r4bp 3 8 biocides manual authorities - europa€¦ · release date: october 2016 7 1. introduction...

How to run BPR processes with R4BP 3 in Member State

competent authorities Release date: October 2016

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Biocides

How to run BPR processes with R4BP 3 in Member State competent authorities

MANUAL for authority users

Biocides


MANUAL for authority users

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Reference: ECHA-16-B-33-EN

Cat number: ED-01-16-966-EN-N

ISBN: 978-92-9495-632-3

DOI: 10.2823/745232

Publ. date: October 2016

Language: EN

© European Chemicals Agency, 2016

Cover page © European Chemicals Agency

Legal notice:

Neither the European Chemicals Agency nor any person acting on behalf of the European

Chemicals Agency is responsible for the use which might be made of the following information.

A wealth of additional information on the European Chemicals Agency is available on the

Internet. It can be accessed through the ECHA website (http://echa.europa.eu).

Reproduction is authorised provided the source is fully acknowledged in the form

“Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written notification

is given to the ECHA Communications Unit ([email protected]).

If you have questions or comments in relation to this document please send them (quote the

reference and issue date) using the information request form. The information request form is

accessible from the Contact ECHA page at: http://echa.europa.eu/contact

European Chemicals Agency

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland

http://echa.europa.eu/contact



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Version Changes Date

Version 1.0 First version. August 2013

Version 2.0

Version 3.0 Version 4.0

Version 5.0

Version 6.0

The manual is updated to incorporate the changes implemented in R4BP 3.1. Six new processes are added, new steps described and streamlined in the process sections, workflow are inserted in the process sections to visualise each single process. New enhanced case event history page has been added. Management of asset document functionality has been added.

The manual is updated to incorporate the changes implemented in R4BP 3.1.2. Four new processes are added: provisional authorisations, renewal of mutual recognition, and new active substance under BPD. The manual is updated to incorporate the changes implemented

in R4BP 3.2. As many as 23 new processes are added. The sequence of the sections has been aligned with that of the industry submission manuals. To avoid repetitions the explanation of the legal framework of each case type (processes) has been referred to the relevant chapters of the BPR practical guide. In the same way the description of the applications

requirements is delegated, when relevant, to the respective submission manuals via dedicated links. To further reduce the length of the document the workflows’ charts have been summarised in one table and are not anymore displayed at the beginning of each section. The manual is updated to describes how the ad hoc

communication supports .xml files and the new communication channels for review programme-related case types work. The SPC sections (3.8.1 to 3.8.3) have also been improved. The

template for the rejection of an application has been repealed since R4BP 3 manages the process automatically. Three new case types have been added: Approval of an active substance in an additional product type, National authorisation cancellation on request and Union authorisation major change on request. Information about meta SPC concept and migration of SPCs from old to new format has been added in the SPC section (3.8.2 and 3.8.3). The CA supporting documents for CA and SPC agreement have been added as Annex I and II in this manual.

April 2014

June 2014 December 2014

February 2016

October 2016

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Table of Contents

1. Introduction ........................................................................................................... 7

2. What is R4BP 3? ................................................................................................... 13

Working in R4BP 3 ................................................................................................ 14

AS-APP Active substance approval ....................................................................... 47

AS-EVA Active substance evaluation under Directive 98/8/EC ............................. 48

AS-NAS New active substance evaluation under Directive 98/8/EC ..................... 50

AS-RNL Renewal of the approval of an active substance ..................................... 50

AS-NPT Approval of an active substance in an additional product type ................ 51

AN-APP (1-5) Amendment of Annex I .................................................................. 51

AN-APP (6) Amendment of Annex I .................................................................... 53

NA-APP National authorisation ........................................................................... 53

NA-APP (WA) Provisional national authorisation Article 55(2) ........................... 55

NA-RNL Renewal of National authorisation ........................................................ 58

NA-RNL Renewal of National authorisation subject to mutual recognition ......... 59

NA-MRP Mutual recognition in parallel ............................................................... 64

NA-MRS Mutual recognition in sequence ............................................................ 67

NA-BBP, NA-BBS National authorisation of the same biocidal product ............... 70

NA-ADC National authorisation - Administrative change on request ................... 73

NA-TRS Transfer of a national authorisation ...................................................... 74

NA-MRG Merge of product authorisations in one product family ......................... 75

NA-MIC National authorisation - Minor change on request ................................. 76

NA-MAC National authorisation - Major change on request ................................ 79

NA-AAT Amendment of National authorisation ................................................... 82

NA-CAT Cancellation of national authorisation ................................................... 84

NA-CCL National authorisation cancellation on request ...................................... 85

ET-NOT Notification for experiment or test ......................................................... 85

NA-NPF Notification of product in product family for national authorisation ...... 86

Settlement of disagreements (n/a) .................................................................... 87

NE-NOT Notification of an unexpected or adverse effect national authorisation . 88

PP-APP Parallel Trade ......................................................................................... 88

PP-AAT Amendment of parallel trade permit ...................................................... 89

PP-CAT Cancellation of parallel trade permit ...................................................... 90

SA-APP National authorisation – simplified procedure ....................................... 90



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SA-BBS Simplified authorisation of the same biocidal product (authorised) ....... 91

SA-BBP Simplified authorisation of the same biocidal product (pending) ........... 92

SA-CAT Cancellation of simplified authorisation ................................................. 92

SA-AAT Amendment of simplified authorisation ................................................. 93

SA-ADC Simplified authorisation administrative change on request ................... 94

SA-TRS Transfer of a simplified authorisation .................................................... 95

SA-MIC Simplified authorisation minor change on request ................................. 95

SA-MAC Simplified authorisation major change on request ................................ 96

SA-NPF Notification of product in product family for simplified authorisation .... 97

SE-NOT Notification of unexpected or adverse effect for SA ............................... 97

SN-NOT Notification for placing on the market - simplified procedure ................ 98

UA-APP Union authorisation ............................................................................... 99

UA-APP (WA) Provisional Union authorisation ................................................. 100

UA-MAC Union authorisation major change on request .................................... 102

Table of Figures Figure 1: R4BP 3 homepage ..................................................................................................... 14

Figure 2: Searching for a task .................................................................................................. 16

Figure 3: ‘Tasks list’ ................................................................................................................. 17

Figure 4: Searching for a message ........................................................................................... 17

Figure 5: Searching for a case ................................................................................................. 19

Figure 6: ‘Case list’ .................................................................................................................. 20

Figure 7: “Case details page” ................................................................................................... 22

Figure 8: Case inventory history page...................................................................................... 23

Figure 9: Searching for an asset .............................................................................................. 23

Figure 10: ‘Assets list’ ............................................................................................................. 24

Figure 11: ‘Asset details’ page ................................................................................................. 24

Figure 12: ‘TASKS’ page ........................................................................................................... 26

Figure 13: ‘MSCA accept’ page ................................................................................................. 26

Figure 14: ‘MSCA accept’ page, release the task function. ....................................................... 27

Figure 15: ‘MSCA accept’ page 1/2 .......................................................................................... 28

Figure 16: ‘MSCA accept’ page 2/2 .......................................................................................... 29

Figure 17: ‘Complete task confirmation’ page .......................................................................... 29

Figure 18: ‘Validate’ page of the “Validate” task. .................................................................... 30

Figure 19: ‘Evaluate’ page of the “Evaluate” task. ................................................................... 30

Figure 20:‘Evaluate & Decide’ page of the “Evaluate & Decide” task. ...................................... 31

Figure 21: Management of SPC files......................................................................................... 31

Figure 22: Management of asset document. ............................................................................ 33

Figure 23: ‘Provide your decision page’1/2 ............................................................................. 37

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Figure 24: ‘Provide your decision page’2/2 ............................................................................. 38

Figure 25: Select the Topic’ page ............................................................................................. 39

Figure 26: Case details – Financial management tab’ page ...................................................... 41

Figure 27: ‘Financial information’ page .................................................................................... 41

Figure 28: ‘Upload new invoice’ page ...................................................................................... 42

Figure 29: ‘Upload new invoice’ page, select language ............................................................ 42

Figure 30: ‘Financial information - send’ page ......................................................................... 42

Figure 31: ‘Confirmation message’ page .................................................................................. 43

Figure 32: ‘Financial information – handle invoices – Fee paid’ page ...................................... 43

Figure 33: ‘Financial information – handle invoices – unpaid’ page ......................................... 44

Figure 34: Tracking the reference case or asset of a same biocidal product ............................ 72

Table of Tables Table 1: Example of process flow chart.................................................................................... 11

Table 2: Case type and SPC correlation table ........................................................................... 34



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1. Introduction

1.1. Objective

This manual addresses users working in the competent authorities of the Member States of

the European Union as well as of Iceland, Norway, Liechtenstein and Switzerland where

appropriate.

The purpose of this manual is to describe the key steps authority users need to perform under

the Biocidal Products Regulation (BPR). It describes the main steps in the IT-tool “Register

for Biocidal Products (R4BP 3)”, to communicate and exchange information with other Member

State competent authorities, the European Chemicals Agency (ECHA) or the Commission.

This manual focusses on the submission and evaluation process of applications and

submissions under the BPR. It will progressively be adapted to cover all the processes

foreseen by the BPR.

1.2. Conventions and terminology

The following text conventions are used throughout this manual:

AS Active substance

MR renewals

Regulation Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014

supplementing Regulation (EU) No 528/2012 of the European

Parliament and of the Council as regards the rules for the renewal of

authorisations of biocidal products subject to mutual recognition

BP Biocidal product

BPC Biocidal Products Committee

BPR Regulation (EU) No 528/2012 of the European Parliament and of the

Council of 22 May 2012 concerning the making available on the market

and use of biocidal products

CAR Competent authority report (for active substance)

cMS Concerned Member State

eCA Evaluating (Member State) competent authority

ECHA European Chemicals Agency

IUCLID International Uniform Chemical Information Database

I6z File format of IUCLID files

MSCA Member State competent authority

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PAR Product assessment report

R4BP 3 Register for Biocidal Products, version 3, established and maintained

by ECHA

rMS Reference Member State (for the process national authorisation

receiving Member State)

PT Product-type

SPC Summary of biocidal product characteristics

UUID

BRC

EAA

MSCA

initiated

Unique Universal Identifier (it can be related to Company, Dossier)

Business Rules Confirmation

ECHA Accept

MSCA initiated

MAA

VAL

MEV

EVL

OPN

MSCA Accept

Validate

MSCA Evaluate

Evaluate and decide

ECHA Opinion

DEC COM Decision

WA Work around. Another case type is used to cover the process. A

supporting document helps to identify the correct process.

The following icons are used throughout this manual:

Useful information, guidance, assistance

Very important note



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1.3. Definitions and concepts

Applicant A legal entity in whose name an application is submitted under

the BPR, e.g. an entity applying for the approval of an active

substance (AS) or a prospective authorisation holder.

Application The formal request to an authority made by the applicant and

evaluated by an authority.

Asset In the R4BP 3 context, an asset is a regulatory decision on an

application (with a unique asset number) related to either an

AS (e.g. a decision on technical equivalence or a decision on

the compliance with Article 95) or a biocidal product (BP) (e.g.

a national authorisation or a Union authorisation), or a

notification (e.g. notification of experiment or test or inquiry).

Asset owner The legal entity in whose name an application or notification is

made under the BPR (e.g. the applicant for product

authorisation, parallel trade permit, decision on technical

equivalence).

Authorisation holder The person established within the Union who is responsible for

the placing on the market of a BP in a particular Member State

or in the Union, and specified in the regulatory decision.

Authority users The authority users are comprised of ECHA, the Member State

competent authorities (MSCA) and the Commission.

Case In R4BP 3, a case relates to an application or notification

submitted by an industry user that follows a series of tasks to

complete a pre-defined workflow. A unique case number

identifies a case in R4BP 3. It includes all the steps in the

application process, which lead to the creation, or the update,

of an asset (the regulatory decision). The case number helps

to manage and view the progress of a submission by both

industry and authority users.

Case owner The legal entity which creates the case and is following it

through its processing, paying any invoices, providing any

additional information requested by authorities, commenting

on any draft evaluation reports or opinions, etc. The case

owner is either the asset owner or the representative of the

asset owner acting on behalf of the asset owner.

Event An event is a step whereby information is submitted that is

needed in the handling / processing of an application.

Examples include the submission of an application, the

submission of additional information on the request of the

authorities, fee payment, and the communication of a

decision.

Industry user The legal entity user registered in R4BP 3.

IVA cycle IVA is the acronym for Initiation, Verification and Authorisation

users. An IVA cycle is a quality tool using the two to three pair

of eyes principle. The first person initiates a task, a second

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person verifies the correctness of the task and the third person

authorises the execution of the task. For MSCAs currently only

the I cycle is implemented in R4BP 3.

Task A working item created by R4BP 3 and assigned to a specific

user group (industry or authority users). A task is created in

order to complete certain actions (e.g. request for additional

information) that are required from the user. These requests

are completed through task items within a defined time period.

The task is identified by the task name and is related to a

particular case number.

1.4. Structure of the document

The structure of the document is as follows: sections 2 and 3 provide a general introduction

to the IT-tool R4BP 3 and its main functions, whereas sections 4 to 44 describe, using a

stepwise approach, the BPR processes relevant to Member States. An overview of all R4BP 3

processes in which MSCA are involved is given in the table of content at the beginning of this

manual.

Each section related to a BPR process is divided in subsections:

1. The “Introduction” subsection provides a link to the relevant chapter(s) of the Practical

Guide where an explanation of the regulatory frame is given.

2. It is followed by the description of the “workflow” types (e.g. BRC > MAA > VAL > EVL).

The acronyms are explained in section 1.2. The dark blue colour highlights the tasks

under MSCA responsibility. They will be explained in details in each subsection “Steps

to be followed by MSCAs”.

3. The “Application requirements” subsection describes, sometimes also referring to the

industry submission manuals, what it is required in a case type (application or

notification) to enable the authority users to correctly receive it.

4. The subsection “Steps to be followed by MSCAs” explains (only) the tasks expected to

be performed by the authority users in a MSCA1. For information on the tasks

performed by the applicant please refer to the relevant industry submission manuals

webpage.

5. Eventually, the subsection “Supporting documents” lists templates (Annex I ans II to

this manual) provided by ECHA to facilitate the MSCA’s work. Please note that this

subsection is only present when supporting documents are required.

6. Table 1: summarises the case types codes, the workflow types and the related

workflow charts. The table of content of this manual explains the case type codes used

in the first column whereas the acronyms in column two are explained in section 1.2.

1 In this manual, authority users are users in an MSCA unless otherwise specified.

http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals



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Table 1: Example of process flow chart

Case types Workflow types Workflow charts

NA-MRP NA-MRS

BRC > EAA > MAA > VAL > EVL

NA-APP NA-RNL NA-MIC NA-MAC NA-BBS NA-BBP SA-BBS SA-BBP

BRC > MAA > VAL > EVL

NA-ADC

NA-TRS NA-MRG

PP-APP SA-APP SA-MAC SA-MIC

BRC > MAA > EVL

NA-NPF ET-NOT SN-NOT SA-NPF SA-ADC SA-TRS SE-NOT

NE-NOT

NA-CCL

BRC > EVL

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NA-AAT

NA-CAT

PP-AAT PP-CAT SA-AAT SA-CAT

MSCA initiated > EVL

AS-RNL AS-NAS UA-APP

AS-NPT

UA-MAC

BRC > EAA > VAL > MEV > OPN > DEC

AS-APP AS-EVA AN-APP (6)

SID > BRC > EAA > VAL > MEV > OPN > DEC

AN-APP (1-5)

SID > BRC > EAA > MAA > MEV > OPN > DEC



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2. What is R4BP 3?

R4BP 3 is an information system established and maintained by ECHA with the aim of

ensuring that the BPR processes are managed by appropriate IT applications, to meet the

requirements set out in the BPR. R4BP 3 provides appropriate functions that allow the

exchange of information between industry and authority users (ECHA, MSCAs and

Commission). R4BP 3 shall be used to record and communicate the decisions on

authorisations taken in the MSCA and at Union level (see Article 71(6) of the BPR).

R4BP 3 consists of two main independent applications, one for all the authority users and

one for industry users.

2.1. Authority application

The R4BP 3 authority application enables authority users to support their day-to-day work

in the regulatory processes. With input from authority users, the system processes the

applications submitted by industry users and facilitates interaction between authority users.

The processes relevant to MSCA authority users are described in the following sections.

2.2. Industry application

The R4BP 3 industry application enables industry users to submit applications, notifications

and information for all processes under the BPR. R4BP 3 also provides the possibility of

monitoring applications, notifications, and asset portfolios. Through the industry interface,

industry users are able to log in, submit applications, review data, download documents

such as invoices, view the status of submitted applications and payments, and receive

notifications from the authorities and complete tasks assigned to them by authority users.

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Working in R4BP 3

3.1 R4BP 3 homepage

After logging into the R4BP 3 portal, you are presented with the “Homepage” of R4BP 3. The

homepage contains the following features (Figure 1):

1. Clicking on the ECHA logo in the top left corner, directs you back to the homepage

from any other page. This feature is available on all of the R4BP 3 pages.

2. The taskbar at the top of the page next to the ECHA label contains four main tabs –

‘TASKS’, ‘MESSAGES’, ‘CASES’ and ‘ASSETS’. Each tab allows you to perform certain

actions or view information related to all of the applications submitted. This taskbar is

available in all of the R4BP 3 pages. More information on each of the tabs is provided

in the following sections of this section.

3. The ‘User ID’ is displayed at the top left corner below the ECHA label, as welcome,

<’user ID’>. This information is displayed in all of the R4BP 3 pages.

4. The log-out button ( button) is available at the top right corner. This feature is

available in all of the R4BP 3 pages.

5. A list of the oldest 10 tasks ‘claimed’ by the user is displayed sorted by submission

date.

6. A list of group tasks is displayed. The system shows 10 ‘All open tasks’ (claimed and

unclaimed), sorted by submission date (oldest on top). Group tasks are all tasks that

are sent to the MSCA, i.e. EVL (evaluation) task, and REC (reply communication) task.

7. Only the 10 latest messages are displayed. Red messages indicate that the message

has not been read yet. The messages are sorted in reversed chronological order by

the receiving date. New unread messages and messages that have been read are

displayed accordingly in the list.

8. Useful explanations can be found on the right hand side, in the yellow ‘Good to know’

box.

Figure 1: R4BP 3 homepage



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3.2 Tasks

A task is a working item that is created automatically during the application process by

R4BP 3 or by an authority user when requesting further information. A task is characterised

by a unique task number and is assigned to a specific industry or authority user. A task is

created in order to complete certain actions that are required from the applicant or another

authority user.

Both tasks and messages are the starting point for an authority user to start working

in R4BP 3. Cases and assets are used for reference, i.e., to know more about the

terms and conditions of an authorisation, to know more about related cases or to

verify in the events history section the status of a case.

3.2.1 Search for tasks

When you select the ‘TASKS’ tab, a page is displayed with a searchable table containing all

of the tasks assigned to you.

You can search for a specific task by filling in some search criteria (Figure 2):

1. Filter task items by: “All open tasks (default)”, ‘Completed’, “ Overdue”, ‘My group(s)

claimed tasks’, ‘My group(s) unclaimed tasks’, ‘Claimed by me’.

2. Task name: e.g. ‘BRC confirmation, ‘MSCA accept’, ‘Evaluate & Decide’, ‘Reply to

communication’.

3. IVA steps: For further information please go to section 3.8.

4. ‘Due date’, ‘Submission date’, ‘Creation date’, ‘Completion date’ filters can be selected

here.

5. The “from” and “to” dates, linked to point 4 can be inserted here.

6. You can search here by ‘Task number’ (please insert only digits).

7. Case number: enter the unique ID of the case. The case number is created in R4BP 3 as

soon as an application is submitted.

8. Case types: the codes and a short description of each case types is given in the drop down

menu. A list of case types is provided in the table of content of this manual.

9. Product name: for applications related to biocidal products, enter the complete product

name.

10. Common name (AS): for IUCLID applications related to active substances, enter the

common name.

11. You can export the selected list of tasks in .xls format (excel) by clicking the “Export (.xls)”

button.

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Figure 2: Searching for a task

When searching for a product name, you can type part of the name

and all the entries containing that letter(s) combination will be

displayed.

Search in R4BP 3 is not case sensitive.

No integrated “Back” button exists. A new search needs to be

performed in R4BP 3 if you select one task and intend to go back to

your initial search results.

3.2.2 The task list

The tasks are displayed in the ‘Tasks list’ (Figure 3) under the ‘TASKS’ tab and include the

following information:

1. Task name describing the task type (e.g.Validate application). The “I” stands for initiator

(you can also find “V” and “A” standing for validator and authoriser respectively). The task

name is a hyperlink to the corresponding task item. For further information please go to

section 3.8.

2. Case number is a hyperlink to the corresponding ‘Case details’ page (Figure 6).

3. Product name if provided in the dossier or in the SPC (when submitting a dossier is not

mandatory).

4. Active substance name.

5. Case type

6. Submission date of the case.

7. Due date.

8. Tasks can have the following statuses:

Unclaimed: all open tasks created and not yet claimed by a specific user.

Claimed: a task that is claimed by a specific user in order to perform the actions

of a task.

Completed: once the claimant of a task performs the task actions and completes

the task, its status changes to ‘Completed’. The task is considered closed; you can

view the task details, but cannot perform any further actions.



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R4BP 3 provides in the task list a reminder feature through which “late”

and “soon to be late” tasks are highlighted. The task will not be auto-

completed even if the deadline is missed but it will appear as late in

the users’ task list.

Figure 3: ‘Tasks list’

3.3 Messages

R4BP 3 is the communication channel between authority and industry users (Article 71(6)

BPR). In particular, an authority user will use the messages tab to check the status of the

messages received and sent via R4BP 3. Information on how to send messages is given in

section 3.10 (ad hoc communication/ new communication). ECHA advises R4BP 3 users to

regularly check whether there are any new messages in their message inbox.

Note that the messages available in the ‘MESSAGES’ tab are in “read-only” format. You

cannot reply to a message from this tab. Please see section 3.10.

Any message sent by you as an authority user will be assigned a unique number, i.e. a

‘Communication number’ or a ‘Decision number’.

You can search for a specific message by filling in some search criteria like (Figure 4):

1. Sent/Received filter buttons.

2. Communication number.

3. Sender: e.g. “Industry”, “Agency” or “MSCA”.

4. Message status: ‘Read’ or ‘Unread’.

5. The received “from” and “to” dates.

Figure 4: Searching for a message

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3.3.1 Message search results

The messages are displayed in the ‘Message list’ under the ‘Messages’ tab and include the

following information:

1. Sender or recipient .

2. Topic: Subject (this is hyperlinked to the communication details)

3. Product/Substance name.

4. Received or Sent Date.

3.4 Cases

A case identifies an application or notification upon successful submission of an application

or notification in R4BP 3. A series of steps need to be completed by authority users in the

application process leading up to the decision according to the BPR. The purpose of a case

is to manage and view the progress of the application and its evaluation.

3.4.1 Search for Cases

When you select the ‘Cases’ tab, a page is displayed with a searchable table containing all

of the cases assigned to you.

You can search for a specific case by filling in some search criteria (Figure 5a, 5b):

1. Case number: unique code create for each application.

2. Case types: the codes and a short description of each case types is given in the drop down

menu. A list of case types is provided in the table of content of this manual.

3. Case status: e.g. In Progress, closed.

4. Dossier UUID: enter the unique universal identifier of the IUCLID dossier (41 alpha-



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numeric code).

5. Evaluating Authority Type: e.g. Agency or MSCA.

6. Evaluating Country (MSCA).

7. Company UUID: enter the unique universal identifier of the relevant company (41 alpha-

numeric entries).

8. Family, Product or Trade name: for applications related to biocidal products, enter the

complete family, product or trade name (Figure 5b).

9. Looking for: for applications related to biocidal products you can seach for Family product

authorisation or Single product authorisations (Figure 5b).

10. Active substance: for IUCLID applications related to active substances, enter the common

name.

11. Product type: List of the 22 product type as reported in Annex V of the BPR.

12. Submission date “From” and “To”.

13. You can export the selected list of cases in .xls format (excel) by clicking the “Export

(.xls)” button.

Figure 5a: Searching for a case

Figure 5b:

The ‘Case list’ is similar to the ‘Task list’.

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Figure 6: ‘Case list’



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3.4.2 Case details page

Specific information on the cases can be found in the case details page. To display the ‘Case

details’ page (Figure 7) click on one of the case number (Figure 6).

The ‘Case details’ page may contain the following information and tabs, depending on the

application type:

Product or Active substance information and Case owner details are displayed it the upper

part of the ‘Case details’ page. From the “Action” button on the top-right you may either initiate an Ad-hoc communication

or download the Case in .pdf format.

Tabs:

1. Reference details

2. SPC tab: The latest submitted SPC file in case of Single product application or the

structure of the latest submitted family SPC file in case of family product applications.

3. Dossiers: List of IUCLID dossiers submitted with the case.

4. Company details: Information about the case owner and asset owner for applications

related to biocidal products or Case owner details - Information about the the case

owner for applications related to active substances.

5. Events history: The authority Events history displays all the events occurred from

initial submission to final decision per case.

6. Documents: Displays all exchanged documents between authority and industry

(including documents generated via the ad hoc communication), except for:

submitted IUCLID dossiers, which are listed under the ‘Dossiers’ sub-tab, and

financial related documents (i.e. invoices, credit notes), which are listed under the ‘Financial management’ sub-tab.

By default, documents are sorted according to their creation date.

7. Financial management: Under this sub-tab, the authority user attaches and sends

invoices/credit notes to the case owner (applicant). You can also change the status

of the invoice, e.g. awaiting payment, unpaid, fee paid, credited. 8. Related cases: Information about any case initiated from the context of the presented

case (i.e. child cases) and any other cases that have been initiated from the same

context as the present case (e.g. cases in other Member States for mutual recognition

in parallel, same BP).

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Figure 7: “Case details page”

The screenshot was taken for the case type ‘UA-APP Application for union authorisation’.

Depending on the case type, the case details page may differ slightly from the one in the

screenshot.

3.5 Event history

In this specific tab all the steps of a case are displayed in chronological order. This information

can be filtered by steps or by the date as shown in Figure 8.

The “events history” page is a useful record of all steps in the sequence of events of a process.

The case event history contains useful information for you such as whether the Agency has

accepted or not an application, dossier UUID or the stakeholder who performs a particular

action.

Steps in red italics can be viewed only by administrator users; steps in bold can be viewed by

administrators, authority and industry users.

The events history tab summarising the submissions from industry or the decisions from the

Authority (completion of task items and requests for resubmission) provides also a link to a

page that summarises the details of each submission/decision or a link to the communication

details page.



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Figure 8: Case inventory history page

3.6 Assets

An asset is a positive regulatory decision on an application related mainly to either an AS

(e.g. approval of the AS or a decision on technical equivalence) or a BP (e.g. a national

authorisation, incl. mutual recognitions, or a Union authorisation), or a notification (e.g.

notification of experiment or test).

Searching for assets is similar to searching cases.

Figure 9a: Searching for an asset

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The searchable table depends on the type of asset selected: related to a biocidal product or

an active substance application (figure 9b).

Figure 9b:

The available asset records are displayed in the ‘Assets list’ (Figure 10)

Figure 10: ‘Assets list’

When a product asset is displayed, also the information on the related active substance(s)

is given in the next column. When the asset number hyperlink is clicked, the ‘Asset details’

page is displayed (Figure 11).

Figure 11: ‘Asset details’ page

Please note that the “create a new case” button allows you to short cut

the steps needed to perform certain processes e.g. amendment or

cancellation of an asset (Figure 11).



25

The ‘Asset details’ page contains different tabs depending on the asset

type: e.g. the “family info” tab only appears for asset related to product

family authorisation.

Authority users will be able to define, which document will be included

in the final asset when finalising the last task item in the workflow

before the asset is created or changed. Additionally will also be able to

manage this document afterwards from the asset tab.

3.7 Case types

An list of BPR processes called ‘case types’ in R4BP 3 can be found in the table of content

of this manual. These processes are described in detail in sections 4 to 47. In addition, a

section on settlement of disagreements is included (Section 28). This process is not a

separate one in R4BP 3 but is relevant for the finalisation of certain processes and this is

the reason why it is included in the present manual.

The processes not relevant for MSCAs are not described in this manual. Information on these

processes can be found however on the ECHA website dedicated to R4BP 3 submissions and

in the appropriate submission manuals for industry also available from the ECHA website.

R4BP 3 does not include all BPR processes. It is foreseen that the missing processes

will be incorporated in future releases. Meanwhile if some of these processes are

necessary, they will be implemented by ECHA in the form of a work around (WA).

3.8 Claiming and completing a task

Under the ‘TASKS’ tab, search for the open tasks in combination with any relevant search

criterion. Click on the task listed as ‘MSCA accept, I - Initiator. The screenshot below provides

an example for ‘MSCA accept I’ (Figure 13). Please keep in mind that for certain processes

the first step is “Validate” (Figure 18)

Step 1: Click on the ‘TASKS’ tab

Step 2: Search for the relevant task, e.g. using the product name and/or case type, i.e.

national authorisation, mutual recognition in sequence, etc.

Step 3: After selecting relevant tasks, click on ‘Search’.

Step 4: Select the task you want to work on.

http://echa.europa.eu/web/guest/support/dossier-submission-tools/r4bp


26

Figure 12: ‘TASKS’ page

Claim a task by selecting ‘Start working’. The task is then automatically assigned to you and

its status is changed to ‘Claimed’ (Figure 13).

Figure 13: ‘MSCA accept’ page



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Figure 14: ‘MSCA accept’ page, release the task function.

As soon as you have claimed the task, you become the user to finalise

it. If you need to release the task in order to be claimed by other users

(a member of yours or of another institution/ministry) you have the

choice to ‘release’ (

Figure 14) the task. By doing this the status is automatically changed

back to ‘Unclaimed’. Releasing a task can be necessary if the claimant

is absent while the task needs to be completed urgently.

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Figure 15: ‘MSCA accept’ page 1/2

Step 1: Provide your decision by selecting “Accept” or “Reject” from the drop-down list

as also explained in section 3.12.

Step 2: Insert a message to the case owner.

Step 3: Upload the relevant document(s).

Step 4: Select type of document you want to upload, language of the document and level

of access (Public, Restricted, Restricted-Authority).

Step 5: Provide any comment. Please note that the comments inserted are only for

internal review.



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Step 6: Complete the task actions and finalise your task item by clicking on ‘complete’

(Figure 16).

The complete button is disabled until the mandatory fields, marked with an

asterisk ( ), have been filled in correctly.

Figure 16: ‘MSCA accept’ page 2/2

Click ‘Continue’ to process the task (Figure 17).

Figure 17: ‘Complete task confirmation’ page

At the end of a process, the applicant receives a message indicating the outcome of the task.

If necessary, a task item to be completed by the applicant might be generated, e.g. if you

request additional information.

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Figure 18: ‘Validate’ page of the “Validate” task.

Figure 19: ‘Evaluate’ page of the “Evaluate” task.



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Figure 20:‘Evaluate & Decide’ page of the “Evaluate & Decide” task.

Figure 21: Management of SPC files.

When more translated SPCs are uploaded, the user needs to define the SPC considered as

master SPC. If only one SPC is provided, the available SPC is by default the master SPC.

A master SPC identifies the SPC used as a reference to determine what key information of

your application shall be displayed in R4BP 3.

The Competent Authority can upload the final master SPC and any relevant translations in

the “Evaluate & Decide” step.



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This area enables the authorities to define the master SPC. You can also amend an asset

(using NA-AAT) and define the SPC file(s) that supports the authorisation after it is granted

in R4BP 3 (see section 3.8.2).

Figure 22: Management of asset document.

This area enables the authorities to define the documents (like PAR, CAR) that will be

attached to the final decision. You can also manage them afterwards through those case

types that support changes in the asset context (e.g. NA-AAT).

3.8.1 SPC

SPC is the acronym for Summary of Product Caracteristics and it’s required by the BPR in

almost every process dealing with authorisations (see table 2).

The manual on how to compile the SPC editor can be downloaded here.

A SPC is always available for you in R4BP 3. The SPC available in R4BP 3 is the starting point

for you to work with. R4BP 3 allows you to download a SPC from the case context, i.e., an

on-going application, or from the asset context, i.e., amendment of a national authorisation.

You must download the SPC provided in the application, insert (potential) missing data and

upload the final SPC in R4BP 3 before finalising the task. Depending on the case type, R4BP

3 will require you to upload the final SPC (see table 2).

Mini-SPCs are available in the following scenarios:

- Cases and assets migrated from R4BP 2; and

- Cases and assets submitted via R4BP 3 prior to 2 December 2014.

Mini-SPCs are SPC templates with minimum information, i.e., active substance and PT

http://echa.europa.eu/support/dossier-submission-tools/spc-editor

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combination; that ensure the appropriate handling of SPCs in R4BP 3 of already existing data

before the SPC became a central part of R4BP 3 in December 2014. These SPCs need to be

replaced by complete SPCs before further actions can be completed (e.g. changes, mutual

recognitions or same product authorisations).

Mini SPCs do not have all the information required in a product authorisation. It is important

to ensure that the SPCs available in R4BP 3 as mini SPCs are completed: if not completed

there may appear authorisations in R4BP 3 without important information like e.g. the AS

name.

Furthermore, by late 2017 the content of the SPC will be disseminated by ECHA (as per

decision of the CA meeting, document CA-Nov15-Doc.4.8) and the content of each SPC should

be completed before being disseminated.

A complete SPC can be added to an authorisation trough the relevant XX-AAT case types. The

terms and conditions of a national authorisation can be found in the SPC available in the

asset. R4BP 3 replaces the content of the SPC in the reference asset based on the latest

successfully “Closed – Approved” change in R4BP 3. If several changes apply to an asset at

the same time, the applicant needs to carefully consider adding up the latest changes in the

latter submission since, once approved, the SPC of the latest “Closed-Approved” case will

determine the terms and conditions available in the SPC. The <Compare with> functionality

in the SPC editor will help you in assessing what new information is added to the SPC of the

latter case.

The final SPC must not include confidential information, as it will be publicly available.

The final SPC is composed of information transferred from R4BP 3 and the SPC file. More

precisely R4BP 3 will transfer the following information: authorisation number, reference

number, authorisation date, expiry date. Furthermore, the following information on the

authorisation holder will be automatically completed: UUID, name, address, postal code, city

and country.

The following table summarises in which processes (case types) related to authorisations a

SPC is needed in the application. A list of definitions of case types is available in the table of

contents of this document.

Table 2: Case type and SPC correlation table

Case type SPC Case type SPC Case type SPC

NA-APP Yes NA-BBS Yes SA-NPF Yes

NA-MRP Yes NA-NPF Yes SA-CAT No

NA-MRS Yes SA-APP Yes SA-AAT amend

NA-RNL Yes (optional)* SN-NOT Yes PP-APP No

NA-CAT No SN-AAT amend PP-AAT No

NA-AAT amend** SN-CAT No PP-CAT No

NA-ADC Yes SA-ADC Yes UA-APP Yes

NA-TRS Yes SA-TRS Yes UA-BBP Yes

NA-MRG Yes SA-MIC Yes NE-NOT No

NA-MIC Yes SA-MAC Yes SE-NOT No

NA-MAC Yes SA-BBP Yes UP-APP Yes

NA-BBP Yes SA-BBS Yes ET-NOT No

NA-CCL No UA-MAC Yes



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* optional means that the SPC is not mandatory but it is suggested

** amend means that the SPC can be submitted by the CA when amending a NA, SA or PP.

The uploaded SPC will not be visible in the newly created case until the case has

passed the ECHA business rules check (BRC).

The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt; maximum

file size is 3GB.

3.8.2 Handling SPC families in R4BP 3

With the release of SPC Editor 2.0, the meta SPC concept has been introduced for a family

SPC.

A meta SPC is a structure of a group of products within a family with a similar composition,

similar uses, same hazard and precautionary statements and a common set of first aid

instructions, disposal, storage and shelf life. For information on the tasks performed by the

applicant please refer to the SPC Editor manual available on ECHA webpage.

A BPF (biocidal product family) can consist of one or more meta SPCs, a meta level might

consist of one or more products.

As part of a biocidal product family application, an applicant needs to include a meta family

SPC containing all members for which an authorisation is sought.

The eCA needs to download the family meta SPC available in the application, edit it and upload

it as part of the final SPC before a national or union authorisation is granted. As a result, R4BP

3 will generate an asset number ending in -0000 related to the family meta SPC and asset

members starting with the same root and ending in 0001, -0002, -0003 for each member of

the family.

The guidance document for implementing of the new concept of biocidal product families is

available on CircaBC (CA-Nov14-Doc.5.8 – Final.rev3).

3.8.3 File migration from SPC 1.0 to SPC 2.0

As a result of the adaptation to the new family structure, ECHA:

- migrated all existing family SPCs in R4BP 3 to the new family structure; and

- updated the SPC online editor to allow structured family applications.

ECHA carried out the automatic migration of existing SPCs for family applications in the

cases/assets available in R4BP 3. The automatic migration process ensures that no data

previously contained in SPCs is lost. However some adaptations may have to be applied to

family SPC anytime R4BP 3 requires their upload in a specific case type. This may happen for:

1) on-going cases where applicants have followed the workaround solution proposed

by ECHA in July 2015 and the new family structure has not been provided yet in

structured format; or

2) when information available in the SPC had to be duplicated.

For point one if there are family cases without any member, the system will add one meta

level and one ‘empty’ product in the converted family SPC. In this scenario you will need to

https://echa.europa.eu/support/dossier-submission-tools/spc-editor

https://echa.europa.eu/documents/10162/14938692/addendum_specific_instructionsproduct_family_applications_en.pdf

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add all the relevant information for the product in the third level of the SPC which appears

empty after the migration.

If there are family assets without any member, the system will create one meta level and one

new member asset in the converted family SPC. In this case as well you will need to add all

the relevant information for the product in the third level of the SPC, which will appear empty

after the migration, by amending the asset with an XX-AAT.

Point two implies that when updating the new family SPC, you will also need to pay special

attention to the removal of any possible duplicates of information, which were necessary in

order to avoid loss of data in the migration procedure. More in detail, please check the

following fields at family level:

1) Manufacturers of the product

2) Manufacturers of the substance and at meta-SPC level

3) Authorised uses

4) General instructions for use

Please check also the content of the field “Other information” where the trade names that

used to be in the old family SPC are migrated as free text.

In any case for the migration to be finalised, for all open cases, you will have to download the

family SPC, and upload it as part of the final SPC. In the Evaluation step, the eCA needs to

download the existing family SPC (evaluate it) and then upload it in order to finalise the

migration. Furthermore for already authorised assets, you may update the migrated SPCs by

using the amendment for authorisations (XX-AAT) case types in R4BP 3. A consultation with

applicants via ad hoc communication may be recommended, in order to give them the chance

to update the SPC.

Please consider that if there were cases or assets containing family SPC in

language A and member SPCs in language B, the system will generate as many

family SPCs as many different languages were present in the old SPC package

(family and member SPCs). Choose only one of them before finalising any

relevant task.

No changes will apply to SPCs for applications for single biocidal products.

3.8.4 Agreeing on and replacing the SPC

In all those processes where an exchange of SPC among CAs is needed before the final

approval/non approval of the application (NA-MRP, NA-MRS, NA-RNL, NA-MIC, NA-MAC,

SA-MIC, SA-MAC and UA-MAC) the RMS/cMS can exchange the draft SPC, for the purposes

of agreeing on the SPC, via ad hoc communication (see section 3.10). The same approach

can be used to agree on the final SPC with the applicant in relevant cases (if the agreed SPC

is requested via the request additional info task the action will “stop the clock” as described

in section 3.9).

The final, agreed SPC in .xml format, must be uploaded by the CA before finalising the EVL

task (Figure 21). If the SPC of an authorisation needs to be amended, the final SPC can also

be uploaded, at a later stage, by the CA using the relevant XX-AAT case types (“amend” case

type in Table 2).



37

3.9 Request additional information with resubmit task

This task needs to be used when the BPR allows additional information to be requested

and a “stop the clock” process is foreseen.

Step 1: Search for the relevant task, e.g. using the product name and/or case type.

Step 2: Claim the task by selecting ‘Start working’.

Step 3: Select ‘Request additional Info’ in the field ‘Please select one of the following

allowed actions based on your decision’ (Figure 23).

Figure 23: ‘Provide your decision page’1/2

Step 4: Type a message to the applicant and set the due date for when your request needs

to be completed (Figure 24).

Step 5: In addition to the field “Message to the owner”, you may also upload a document

describing your request for additional information, set the language in which the

38

request is written and put the relevant classification type (Figure 26)

Step 6: Complete the task.

Figure 24: ‘Provide your decision page’2/2

The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt;

maximum file size is 3GB.

3.10 Ad hoc communication (New communication)

An ad hoc communication (also known as new communication) may be used to

Member States and ECHA about decisions taken by a MSCA or to create a task for

applicant for which no submission of data by the applicant is necessary (e.g. to

the payment of an invoice or exchange a SPC .xml file). Using the financial tab (

Figure 27) will generate only a message to the applicant; using the ad hoc communication

will also create a task to the applicant.



39

Step 1: Search for the relevant case, e.g. using the product name and/or case type (Figure

5 a,b).

Step 2: In the relevant ‘Case details’ page, press the ‘Actions’ button and select ‘New

communication’ (Figure 7).

Step 3: Fill in the requested fields in the ‘Ad hoc communication’ box to create a new

communication. In the field ‘Topic’, select the best fitting option.

Figure 25: Select the Topic’ page

For authority users, only some subjects from the dropdown menu are

relevant, e.g. evaluation, ad hoc invoicing, comments, opinion, SPC,

product sameness and validation.

Step 4: Tick the box ‘Reply required’ and set the appropriate deadline in days. Only

when the box ‘Reply required’ is ticked a task to the recipient will be

created. In other cases, the message will be delivered to the Messages tab.

Step 5: By selecting the click box “reply required” and pressing ‘Send’ the communication

is forwarded to the applicant, the appropriate MSCAs or to ECHA. A task will be

created for the user to which you have sent your communication.

40

Under the ‘Events history’ sub-tab in the ‘Case details’ page (Figure 8), you can see that

the message was sent out.

The documents you attached to the ad hoc communication are accessible via the

‘Documents’ sub-tab in the ‘Case details’ page.

Step 6: Click ‘Continue’ to proceed.

With the ad hoc communication in R4BP 3, no IUCLID dossier or SPC

can be requested (and be update automatically). Should you require a

IUCLID dossier or an amended SPC from the applicant, you need to

use the ‘Request additional information’ with the resubmit task (section

3.9).

Choose the topic ‘Comment’ in the topic field, if no better selection is

available in the dropdown menu.

The ‘Request additional information’ function (section 3.9) stops the

clock and puts on hold the running time the MSCA has for a task (legal

period). Therefore, to ask for clarification to resolve small

inconsistencies in the dossier, or in all cases where a stop of the clock

is not foreseen by the BPR, the MSCA may use the ad hoc

communication, which does not have any effect on the task duration

and does not trigger the possibility for resubmission of a IUCLID file.

With the ad hoc communication you can request an SPC in .xml format

but it will not be uploaded automatically. You still need to upload it

manually before approving the case.

The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt;

maximum file size is 3 GB.

3.11 Invoicing, financial information

The creation of national invoices is out of the scope of R4BP 3.

Therefore, each MSCA should use its own system to prepare invoices.

However, R4BP 3 needs to be used for sending the invoice to the

applicant and to record the status of the payments.

MSCA should invoice only after a relevant task has been created by the

system e.g. “MSCA accept” or “Validate”. By failing to do so there is a

risk that an invoice is sent before the previous step is actually

completed and the invoice have to be refunded if the application is

rejected in the previous step.

Step 1: Search for the relevant case, e.g. using the product name and/or case type.

Step 2: Open the ‘Case details’ by clicking on the case number hyperlink.



41

Step 3: Under ‘Case details’, select the ‘Financial management’ sub-tab.

Figure 26: Case details – Financial management tab’ page

Step 4: Under ‘Financial management’, click the ‘Upload invoice’ button in the ‘Handle

invoices’ section (

Step 5: Figure 27).

Figure 27: ‘Financial information’ page

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Step 6: Fill in the fields and upload the pdf file of your original invoice. Choose the

language in which the invoice has been created (Figure 28 and Figure 29).

Figure 28: ‘Upload new invoice’ page

Figure 29: ‘Upload new invoice’ page, select language

Step 7: Click ‘Send’ in order to send the invoice to the applicant (Figure 30).

Figure 30: ‘Financial information - send’ page



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Step 8: Click ‘Continue’ to proceed.

Figure 31: ‘Confirmation message’ page

Step 9: Once you have received the payment, change the fee status from ‘Awaiting

payment’ to ‘Fee paid’ in the ‘Financial management’ sub-tab of the relevant case

(Figure 32). The applicant will be informed automatically via R4BP 3.

Figure 32: ‘Financial information – handle invoices – Fee paid’ page

Step 10: If the fee has not been paid within 30 days, change the fee status to ‘Fee unpaid’

in the ‘Financial management’ tab of the relevant case (Figure 33). According to

the BPR, the application is to be rejected if the fees are not paid within 30 days.

44

Figure 33: ‘Financial information – handle invoices – unpaid’ page

For all national processes (i.e. except those relevant at Union level), you can reject a case

yourself, if the payment is not done within 30 days.

For processes related to Union level, an ad hoc communication needs to be sent to ECHA

requesting the rejection of the application due to non-payment of the invoice. ECHA will then

reject the application in R4BP 3.

Processes at Union level include: active substance approval (including renewal, amendment

and review of active substance approval) and Union authorisation of biocidal products

(including a change, authorisation of the same and renewal of Union authorisation).

Cancelling and changing invoices can be recorded by setting the status of the invoice to

‘Credited’. You can then upload the credit note and the corrected invoice. By clicking ‘Send’,

both documents are sent to the applicant.

3.12 Acceptance, validation, evaluation,

approval/rejection

Generally, the workflow of biocides processes follows the pattern of acceptance, validation,

evaluation and ends resulting in an approval, non-approval or a rejection of an application.

Rejection can be the outcome at any of the steps. Please note that these terms are not

related to legal acts (decisions, regulations) but only to the applications themselves.

Acceptance is the first step in the processing of an application and it is finalised once the

payment is received. If an invoice is not paid within the given deadline, the application will

be rejected at this stage. The acceptance step has to be finalised within the 30 days deadline.

The validation is understood to be a verification step to ensure the application is complete.

The time for the MSCAs to finalise the validation step is usually 30 days from acceptance

date. More information on which issues need to be validated is described in the sections of

the specific processes in this manual. If the application is found to be invalid, a request for

additional information can be made that must be completed by the industry user within a

defined deadline. In some processes, the validation step was used for confirmation whether

the full evaluation is needed or not.



45

The evaluation of the applications follows the validation step. Once the validation is

finalised, the evaluation of the application can start. The evaluation time of the eCA (or the

rMS) depends on the process. If further information is needed during this step, a request

for additional information can be made that must be completed by the industry user within

a defined deadline. This action will “stop the clock” and the eCA (or the rMS) will need to

specify the deadline industry has to comply with the request.

Approval is the positive outcome of the process after the evaluation step (for those case

types managed by the MSCA). For cases having SPC the authority user should further review

and update, if required, the SPC package (in the correct .xml format) of the final SPC files

attached for the specific case.

Non-approval is the negative outcome of the process after the evaluation step (for those

case types managed by the MSCA).

Rejection is a negative outcome, that can occur in the acceptance, the validation or the

evaluation steps. Rejection is appropriate to use in cases of non-payment of the fee or failure

to submit additional information requested by the authority (where this is justifiable by the

legislation).

To approve, non-approve or reject an application in R4BP 3, select the appropriate option

from the drop-down menu of the relevant task page and upload the decision and, where

relevant, the appropriate documents (e.g. SPC). Complete the task page to move to the

following task or to close the application.

Applications for approval of active substances and for Union

authorisation of biocidal products can only be approved or non-

approved by Commission in R4BP 3.

If the applicant fails to pay the fee within the 30-day deadline, the

MSCA should reject the application and complete the task or inform

ECHA if it relates to an application for which a MSCA cannot reject.

3.13 Business rules – quality of dossiers

Before applications are accepted by ECHA they pass through the ECHA submission pipeline.

This includes a virus check, format validation and a check of process specific business rules.

It also applies for resubmit tasks when a new dossier is required (request for additional

information).

You can find more information on the submission to ECHA in Chapter 6 ‘How ECHA handles

your submission’ of the Biocides Submission Manual - Technical guide: using R4BP 3 for

biocide applications directed at applicants.

3.14 Classification of documents – Access level

Authorities have to classify the documents they upload:

Public: meaning that the document may be disseminated as uploaded and visible to

both industry and authority users in the asset/case/task/message context that it is

uploaded in.

Restricted: meaning that the document is visible to both industry and authority users

in the asset/case/task/message context in which it is uploaded, but it will not be

disseminated as uploaded.

Restricted – Authority: meaning that the document is only visible to authority users in

the asset/case/task/message context in which it is uploaded and will not be

disseminated as uploaded

http://echa.europa.eu/documents/10162/14938692/bsm_02_using_r4bp3_en.pdf

46

Important note about the access level: When uploading your supporting

documents in the R4BP 3, you are required to indicate an ‘access level’ as

either ‘public’, ‘Restricted’ or ‘Restricted to Authority’. The ‘access level’ is

purely indicative and is in no way binding on ECHA.

3.15 What to do if you need support

ECHA offers a dedicated service to the MSCAs in using the Agency’s information systems

and performing their duties in the context of the BPR.

You can address your questions via the contact form:

https://comments.echa.europa.eu/comments_cms/MSCA_ITsupport_form.aspx

https://comments.echa.europa.eu/comments_cms/MSCA_ITsupport_form.aspx



47

AS-APP Active substance approval

4.1 Introduction

Please consult this chapter of the BPR Practical Guide for a description of the regulatory

requirements and the related process.

4.2 Workflow


4.3 Application requirements

Please consult this Biocides Submission Manual for a description of the application

requirements related to this process.

4.4 Steps to be followed by the MSCA

The eCA needs to claim the task during the approval process and can request further

information through the task item.

Step 1: Claim the ‘Validate’ task.

Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant

via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section

3.11). If the fee is not paid within 30 days reject the application (see section 3.12)

Step 3: Complete the actions in the “Validation” page (Figure 18).

Validate the application within 30 days of receiving the task from ECHA according to BPR

Articles 7(3). This validation includes verifying whether:

a. the information requirements for the active substance are fulfilled;

b. the information requirements for the representative product(s) are fulfilled;

c. BPR Article 5(2) is applicable if exclusion criteria are met according to BPR Article

5(1);

d. Justifications have been submitted for the adaptation of information requirements.

The validation should not include an assessment of the quality or the adequacy of the data

or justifications submitted.

e. If the information requirements are fulfilled, complete the validation task and

follow on with Step 4.

f. If the information requirements described above are not fulfilled, inform the

applicant what additional information is required for validating the application

(further information in sections 3.9). Set a reasonable time limit for the submission

of the additional information. This shall normally not exceed 90 days.

g. Validate the application within 30 days of receipt of the additional information. Reject the application if the applicant fails to submit the requested information

http://echa.europa.eu/documents/10162/21742587/pg_on_bpr_1_approval_active_substances_en.pdf

http://echa.europa.eu/documents/10162/14938692/bsm_04_active_substances_en.pdf

48

within the deadline or the information requirements remain incomplete. In such

case, part of the fees paid by the applicant to the eCA may need to be reimbursed.

Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page

(Figure 19).

Evaluate the application within 365 days (BPR Article 8(1)). The following tasks related to

R4BP 3 can be considered during the evaluation:

a. Annotate IUCLID2 file where relevant.

b. via the request additional information function you can request further information

and stop the clock. Set a reasonable time limit for the submission of the additional

information. This shall normally not exceed 180 days. Reject the application (see

section 3.12) if the applicant fails to submit the requested information within the

deadline. The applicant will be automatically notified.

c. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on

issues identified that may need to be discussed at a working group meeting already

before submitting the competent authority report (CAR) and the dossier enters

the peer review phase.

d. Inform ECHA via ad hoc communication if the active substance is a potential

candidate for substitution.

e. Perform confidentiality claims check by evaluating the justifications submitted by

the applicant.

f. According to the ECHA’s procedures it is suggested that not later than 60 days

before the end of the 365-day evaluation period, the eCA would send the CAR and

conclusions for a 30-day commenting period to the applicant. Reply to the

applicant’s comments and adapt the CAR accordingly if necessary.

Step 5: Peer review

Send the CAR to ECHA for initiation of the peer review stage. According to the

“Working procedure for active substance approval”, Table 1, the CAR should be

submitted via R4BP 3.

4.5 Supporting documents

Template agreement to act as CA.

AS-EVA Active substance evaluation under Directive

98/8/EC

5.1 Introduction



2 Guidance on IUCLID is available on ECHA website here: https://iuclid6.echa.europa.eu/support.


https://iuclid6.echa.europa.eu/support



49

5.2 Workflow



This process derives from the assessment of the existing active substances under the BPD

and is supported by Article 90 of the BPR and the Review Programme Regulation (EU) No

1062/2014. The only application requirement is for the active substance to be in the review

programme. All AS/PT combinations have been created in R4BP 3. The case owner is either

the participant or the task force leader. The management of participants (Article 95 list

management) takes place outside R4BP 3.


Step 1: Complete the actions in the “Validation” page (Figure 18).

a. If the application is incomplete, inform the applicant that additional information is

required for validation. Through ‘request additional information’ (see section 3.9)

a resubmission task item for the applicant is created. Set a reasonable time limit

for the submission of the additional information. This shall normally not exceed 90

days. Reject the application if the applicant fails to submit the requested

information by the deadline (see section 3.12).

b. If the information requirements are fulfilled, complete the validation task within 30

days of receipt additional information and follow on with Step 2.

c. Reject the application if the applicant fails to submit the requested information by

the deadline (see section 3.12). The applicant and ECHA will be notified

accordingly.

Step 2: Claim the “Evaluate” task and complete the task actions (Figure 19).

Evaluate the application (the Review Regulation sets PT-dependent deadlines – Annex III).

The following tasks related to R4BP 3 can be considered during the evaluation:

a. When relevant, annotate IUCLID file and/or the study summaries.

b. Consult with ECHA via ad hoc communication if additional information is required.

Request additional information (‘stop the clock’) as described in Step 3 b above to

the applicant. If you ‘stop the clock’, please inform ECHA via ad hoc communication

(see sections 3.9).

c. Inform ECHA on issues identified that may need to be discussed at a working group

meeting via ad hoc communication already before submitting the CAR and the

dossier enters the peer review phase.

d. Inform ECHA if the active substance is a potential candidate for substitution via ad

hoc communication.

e. Perform the confidentiality claims check by evaluating the justifications submitted

by the applicant.

f. According to the ECHA’s procedures it is suggested that not later than 60 days

before the end of the evaluation period, the eCA would send the CAR and the

conclusions for a 30-day-commenting period to the applicant. Reply to the

applicant’s comments and adapt the CAR accordingly if necessary.

https://staging-production.echa.europa.eu/regulations/biocidal-products-regulation/legislation?panel=implementing_legislation

https://staging-production.echa.europa.eu/regulations/biocidal-products-regulation/legislation?panel=implementing_legislation

50

Step 3: Peer review

Send the CAR to ECHA for initiation of the peer review stage. According to the

“Working procedure for active substance approval”, Table 1, the CAR should be

submitted via R4BP 3.

AS-NAS New active substance evaluation under Directive 98/8/EC

6.1 Introduction


requirements and the related process. All AS/PT combinations have been created in R4BP 3.

The case owner is either the participant or the task force lead. The management of

participants (Article 95 list management) is lead outside R4BP 3.

6.2 Workflow

MEV > OPN > DEC


This process derives from the assessment of the new active substances under the BPD and

is supported by Article 90 of the BPR. The only application requirement is that an approval

request was submitted for a new active substance under the BPD.


Please follow the steps 4 and 5 in section 4.4.


Template agreement to act as eCA.

AS-RNL Renewal of the approval of an active substance

7.1 Introduction



7.2 Workflow


Please note that in this case type the validation task is used by eCA to decide whether a

full evaluation is required or not.





http://echa.europa.eu/web/guest/practical-guides/bpr-practical-guides




51


See section 4.4


Template agreement to act as eCA.

AS-NPT Approval of an active substance in an additional product type

8.1 Introduction



8.2 Workflow






See section 4.4


Template agreement to act as eCA (it should be the same eCA of the original dossier).

AN-APP (1-5) Amendment of Annex I

9.1 Introduction

The process relates to the amendment of category 1 to 5 of Annex I to the BPR.



9.2 Workflow

BRC > EAA > MAA > MEV > OPN > DEC








52


Step 1: Claim the “MSCA accept” task.



3.11).

Step 3: Complete the actions in the “MSCA accept” page (Figure 17).

Check whether the fee has been paid within 30 days (3a) or not (3b).

a. If the fee has been paid, accept the application and proceed with Step 4. The

applicant will be notified accordingly by the system.

b. If the fee has not been paid, reject the application. The applicant will be

automatically notified.


(Figure 19).

Evaluate the application within 180 days. The following tasks related to R4BP 3 can be

considered during the evaluation:

a. via the request additional information function you can request further information

and stop the clock. Set a reasonable time limit for the submission of the additional

information. This shall normally not exceed 180 days. Reject the application (see


deadline. The applicant and ECHA shall be notified.

b. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on


before submitting the competent authority report (CAR) and the dossier enters

the peer review phase.

c. Perform confidentiality claims check by evaluating the justifications submitted by

the applicant.

d. ECHA suggests that not later than 60 days before the end of the 180-day

evaluation period, the eCA would send the CAR and conclusions for a 30-day

commenting period to the applicant. Reply to the applicant’s comments and adapt

the CAR accordingly if necessary.

e. Complete the Evaluate task selecting “Submit evaluation”.

Step 5: Peer review

Send the CAR to ECHA for initiation of the peer review stage. According to the “Working

procedure for active substance approval”, Table 1, the CAR should be submitted via R4BP 3.





53

AN-APP (6) Amendment of Annex I

10.1 Introduction

The process relates to the amendment of category 6 of Annex I to the BPR.



10.2 Workflow






The procedure to be followed is the same of AS-APP or AS-EVA. Please See section 4.4.



NA-APP National authorisation

11.1 Introduction



11.2 Workflow






The steps described here are not relevant for applications for mutual

recognition in parallel. If you are the rMS for an application, which shall

be mutually recognised in parallel, please refer to section 15.







http://echa.europa.eu/documents/10162/14938692/bsm_06_national_authorisation_en.pdf

54

3.11).




applicant will be notified accordingly by the system.



Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure

18).

Validate the application within 30 days of the acceptance date. According to the

BPR (Article 29(2)), the validation includes verifying:

whether the relevant information described in Article 20 of the BPR has been

submitted;

that the statement of the applicant that no application for national authorisation of

the same biocidal product for the same use has been submitted to any other MSCA.

A template is provided by ECHA on the website and should be included in the

application by the applicant as a supporting document.

The validation shall not include an assessment of the quality or adequacy of the

data or justifications submitted.

a. If the information requirements described above are fulfilled, complete and

proceed with Step 5.

b. If the information requirements described above are not fulfilled, inform the

applicant of the additional information that is required for validation. Through

‘request additional information’ (see section 3.9) a resubmission task item for the

applicant is created to submit an updated IUCLID dossier or other file type

supported by the case type wizard.

Set a reasonable time frame for the submission of the additional information which

should normally not exceed 90 days. Validate the application within 30 days of

receipt of the additional information.

Reject the application if the applicant fails to submit the requested information by

the deadline (see section 3.12).

c. If the applicant has already submitted an application for national authorisation for

the same biocidal product and the same use in another Member State, reject the

application and inform the applicant of the possibility of seeking mutual

recognition. As R4BP 3 does not allow checking this by searching the data base at

the moment, this has been implemented by the obligatory inclusion of the above

mentioned supporting document by the applicant.



55

Step 5: Claim the “Evaluate & Decide” task

Within 365 days, evaluate whether an authorisation can be granted in accordance

with Article 19 of the BPR. This evaluation step takes place outside R4BP 3. The

following tasks related to R4BP 3 can be performed during the evaluation:

a. Annotate IUCLID file where relevant.

b. Request additional information from the applicant if necessary to carry out the

evaluation. Through ‘request additional information’ (see section 3.9) a

resubmission task item for the applicant is created to submit a new IUCLID dossier

or other file type and it will stop the clock. Set a reasonable period for the

submission of the additional information, which should normally not exceed 180

days in total. Reject the application (see section 3.12) if the applicant fails to

submit the requested information within the deadline. The applicant will be


c. Draft a product assessment report (PAR) summarising the conclusions of the

assessment and the reasons for authorising or refusing to grant the authorisation.

Amend if necessary the draft SPC generated by the applicant. Send an electronic

copy of the PAR and the SPC to the applicant through ad hoc communication (see

section 3.10) and provide the opportunity to submit comments within 30 days

(request reply).

d. Finalise the assessment taking into account the comments provided by the

applicant.

e. Perform a confidentiality claims check by evaluating the justifications submitted by

the applicant.

f. Complete the actions in the “Evaluate & Decide” page by selecting “Approve

application” (Figure 20).

Close the task by approving or not approving the application for the product authorisation

(see section 3.12) and at the same time upload the final PAR and SPC to R4BP 3.

The final SPC must not include confidential information, as it will be made

publicly available.

Applications for authorisation of the same biocidal product will appear as

related asset of the reference product (see Article 7 of the Implementing

Regulation (EU) No 414/2013, amended by Regulation No 2016/1802).

Whenever an authorisation is granted or not, the related cases should be

checked as the connections are not automated.

NA-APP (WA) Provisional national authorisation Article 55(2)

12.1 Introduction




56

12.2 Workflow






Step 1: Claim the “MSCA accept” task (see section 3.8).



3.11).


Check in your national invoicing system whether the fee has been paid within 30

days (3a) or not (3b).

a. If the fee has been paid, complete and proceed with Step 4. The applicant will be

notified accordingly.




18).

Validate the application within 30 days of the acceptance date. According to the

BPR (Article 29(2)), the validation includes verifying:

i. whether the evaluating competent authority has given a recommendation

for approval in the CAR (please check the CAR uploaded in the R4BP 3 or

CIRCA BC page under the new active folders);

ii. whether the relevant information described in Article 20 of the BPR has

been submitted;



a. If the information requirements described above are fulfilled, complete and proceed

with Step 5 by selecting “Validate”.

b. If the information requirements described above are not fulfilled, inform the applicant

of the additional information that is required for validation. Through ‘request additional

information’ (see section 3.9) a resubmission task item for the applicant is created to

submit an updated IUCLID dossier.

i. Set a reasonable time frame for the submission of the additional information

which should normally not exceed 90 days. Validate the application within 30

days of receipt of the additional information.

ii. Reject the application if the applicant fails to submit the requested information




57

by the deadline (see section 3.12).

c. If the applicant has already submitted an application for national authorisation for the

same biocidal product and the same use in another Member State, reject the

application and inform the applicant of the possibility of seeking mutual recognition.

As R4BP 3 does not allow checking this by searching the data base at the moment,

this has been implemented by the obligatory inclusion of the above mentioned

supporting document by the applicant.

Step 5: Claim the “Evaluate & Decide” task

Evaluate whether an authorisation can be granted in accordance with Article 19 of the

BPR. The duration of the evaluation period is still under discussion by the COM services.

The following tasks related to R4BP 3 can be considered during the evaluation:



evaluation. Inform the applicant what additional information is required. Through


applicant is created to submit a new IUCLID dossier or other file type and it will

stop the clock. Set a reasonable period for the submission of the additional

information which should normally not exceed 180 days in total.

Reject the application (see section 3.12) if the applicant fails to submit the

requested information within the deadline. The applicant will be automatically

notified.



Amend if necessary the draft SPC generated by the applicant.

d. Perform a confidentiality claims check by evaluating the justifications submitted by

the applicant.

e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc

communication (see section 3.10) and provide the opportunity to submit

comments within 30 days (request reply). Finalise the assessment taking into

account the comments provided by the applicant.

f. Complete the actions in the “Evaluate & Decide” page by selecting “Approve

application” (Figure 20).

Close the task by approving or not approving the application for the product

authorisation (see section 3.12) and the same time upload the final PAR and SPC

to R4BP 3.

The final SPC must not include confidential information, as it will be publicly

available (see section 3.8.1).

Applications for authorisation of the same biocidal product will appear as

related asset of the reference product (see Article 7 of the Implementing

Regulation (EU) No 414/2013, amended by Regulation No 2016/1802).

Whenever an authorisation is granted or not, the related cases should be

checked as the connections are not automated.

* The duration of the evaluation period is still under discussion within the COM

58

services.

NA-RNL Renewal of National authorisation

13.1 Introduction



13.2 Workflow





MSCAs need to determine whether they are rMS or cMS.



Step 2: Check that there is no supporting document in the document tab and proceed

directly with Step 3. In case there is a supporting document this means that the

case refers to a mutual recognition renewal and you should refer to section 14.



3.11).



a. If the fee has been paid accept the application and proceed with Step 4. The

applicant will be notified accordingly.

b. If the fee has not been paid, reject the application (see section 3.12) and inform

the applicant accordingly through ad hoc communication (see section 3.10).

Similarly, inform the rMS if relevant (if a supporting document is present in the

application).


18).

Decide within 90 days of accepting an application whether a full evaluation of the

application for renewal is necessary taking account of all product-types for which

renewal is needed. A tick box is provided in R4BP 3 to support this option.

Step 6: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &

Decide” page (Figure 20).

In case a full evaluation of the application is necessary, evaluate it within 365 days whether

a renewal of an authorisation can be granted in accordance with Article 30 of the BPR. This

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59

evaluation step takes place outside R4BP 3. The following tasks related to R4BP 3 can be

performed during the evaluation:





or other file type and it will stop the clock.

c. Set a reasonable time frame for the submission of the additional information which

should normally not exceed 180 days in total. Reject the application (see section

3.12) if the applicant fails to submit the requested information within the deadline.

The applicant will be automatically notified.

d. Draft a product assessment report (PAR) summarising the conclusions of the



e. Send an electronic copy of the PAR and SPC to the applicant through ad hoc

communication (see section 3.10) and provide the opportunity to submit

comments within 30 days (request reply). Finalise the assessment taking into

account the comments provided by the applicant.

In case a full evaluation of the application is not necessary evaluate it within 180 days of

accepting the application.

Complete the actions in the “Evaluate & Decide” page by selecting “Approve application”

(Figure 20).

Close the task by approving or not approving the application for the renewal of national

authorisation (see section 3.12) and at the same time, if relevant, upload the final PAR and

SPC to R4BP 3.


available (see section 3.8.1).

NA-RNL Renewal of National authorisation subject to mutual recognition

14.1 Introduction

This is in practice the same case type used for single product authorisation renewal except

that the applicant will request in a single submission the renewal of all (or some) the assets

related by mutual recognition. Communication with concerned MSCA is therefore needed.



14.2 Workflow


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60




MSCAs need first to determine whether they are rMS or cMS by checking the

supporting document.

The grouped submission of renewal application is the principle introduced by

the Commission Regulation No 492/2014 in order to avoid unnecessary

duplication of the evaluation procedures by the Competent Authorities (CA).

This practical approach is also recommended for the sake of consistency during

the evaluation process. However, in case of mutually recognised

authorisations, which have different Authorisation Holders the grouped

submission is not mandatory and up to the Authorisation Holder choice to

nominate another company making the grouped application for renewals.

In case companies decide to submit the applications for renewal separately,

these separate applications may not be linked together and could therefore be

evaluated separately by the (possibly different) receiving MSs as it is described

in Article 31 of the BPR (taking into account exceptions for biocidal products

containing chlorophacinone, bromadiolone or coumatetralyl).

Note also technical limitations explained below due to which two or more

submissions may need to be combined for evaluation by a single rMS under

the Commission Regulation No 492/2014.

14.4 Steps to be followed by the reference MSCA


Step 2: A supporting document (Renewal of authorisation subject to mutual recognition)

should be present under the Documents tab. If there is no supporting document

this means that the case refers to a renewal not involving any mutual recognition

and you should refer to section 13.

Step 3: If there is such supporting document, check in the supporting document whether

you are rMS or cMS. Please note that this information or the related cases cannot

be read from the case details. Furthermore, since there may be missing links in

the R4BP 3 database among the related NA assets, applicants may need to apply

under the regulation 492/2014 in more than one submissions. The kind of

submission (main or additional) can be deduced from the supporting document(s).

The rMS is given by the asset from which the applicant starts the main submission.

The additional submissions cover related assets that could not be included in the

main submission for which the corresponding competent authorities become cMSs.

In order to ensure the information on the rMS/cMS and the additional submissions

is available to all rMS/cMS and to potentially enable their combined assessment

with the main submission, ECHA will send the supporting documents of the main

and additional submissions to the rMS and the cMS through ad hoc communication.

For cMS next steps refer to section 14.5.



3.11).




61





b. If the fee has not been paid, reject the application (see section 3.12). The applicant

will be notified accordingly. Inform the concerned CA through ad hoc

communication (see section 3.10).


18).

Within 30 days of the acceptance in the reference Member State, that Member

State shall validate the application if it contains all the relevant information

referred to in Article 2.

a. If the information requirements described above are fulfilled, select “Validate”

complete and proceed with Step 6.

b. If the information requirements described above are not fulfilled, request additional

information (section 3.9) and set a reasonable period for the submission of the

additional information, which should normally not exceed 90 days in total.

c. Select “reject” if the additional information are not sufficient to validate the

application.

d. Decide within 90 days of accepting an application whether a full evaluation of the

application for renewal is necessary taking account of all product-types for which

renewal is requested. A tick box is provided in R4BP 3 in the validation page to

support this option. The reference CA must send an ad hoc communication to the

concerned CAs to inform them about the evaluation type of their choice.



In case a full evaluation of the application is necessary, evaluate it within 365 days* whether

a renewal of an authorisation can be granted in accordance with Article 30 of the BPR. The

following tasks related to R4BP 3 can be considered during the full evaluation:





or other file type and it will stop the clock. Set a reasonable time frame for the

submission of the additional information which should normally not exceed 180





assessment and the reasons for renewal or refusing to renew the authorisation.


d. Send an the PAR and SPC to the applicant through ad hoc communication (see

62


(request reply). Finalise the assessment taking into account the comments

provided by the applicant.

e. Within 365 days of validating the application, the rMS shall send draft PAR and SPC

through ad hoc communication to the cMS and to the applicant.

*In case a full evaluation of the application is not necessary evaluate it within 180 days of

validating the application. Please note that in this case step 6(b) does not apply.

Agreement by cMS and decision taking:

a. All the cMSs express their position on the draft SPC within 90 days of the receipt

of the draft PAR and SPC from rMS by sending their decision on the agreement

through ad hoc communication to the rMS, the other cMSs and the applicant. If a

cMS expresses a disagreement with the draft SPC and the PAR prepared by the

rMS, the rMS shall refer the detailed explanation of the points of disagreement and

the reasons for position received from the cMS to the Coordination Group without

delay (see section 28).

b. Following the 90 days, the rMS will take a decision on the renewal of the national

authorisation within 30 days and close the task by approving or not approving the

application for the renewal of national authorisation (see section 3.12). The rMS

uploads the agreed SPC and the final PAR in R4BP 3 together with any agreed

terms and conditions on the making available on the market or use of the biocidal

product.


available.

14.5 Steps to be followed by the concerned MSCAs


Step 2: Check whether there is a supporting document (Renewal of authorisation subject

to mutual recognition) under the Documents tab (sent to you by ECHA) which

indicates who the rMS and the respective cMSs are. The supporting documents

you receive should be giving you the status of cMS. This information or the related

cases cannot be read from the case details in the R4BP 3.

Furthermore, since there may be incorrect links in the R4BP 3 database among

the NA assets, applicants may need to apply under the regulation 492/2014 in

more than one submissions. The kind of submission (main or additional) can be

deduced from the supporting document(s).

The rMS is given by the asset from which the applicant starts the main submission.

The additional submissions cover related assets that could not be included in the

main submission for which the corresponding competent authorities become cMSs.

In order to ensure the information on the rMS/cMS and the additional submissions

is available to all rMS/cMS and to potentially enable their combined assessment

with the main submission, ECHA will send the supporting documents of the

additional submissions to the rMS and the cMS through ad hoc communication.




63

via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section 3.11).



a. If the fee has been paid, complete and proceed with Step 4. The applicant will be



will be automatically notified. Send the information also to the rMS and where

relevant other cMSs through ad hoc communication (see section 3.10) using the

template mentioned in the supporting documents section below.

Step 5: Claim the ‘Validate’ task.

Provided that the rMS has validated the application, within 30 days of the

acceptance the concerned Member State(s) will verify that the application it has

received falls within the scope of the supplementary rules for renewal as per Article

1(2) and (3) of Commission Delegated Regulation (EU) No 492/2014. If not, the

application for renewal must be processed under the regular renewal procedures

set out in Article 31 of the BPR. In this case the MSs shall inform the other

concerned MS via ad hoc communication. Such MS should process the application

following the steps described in section 13.4.

A tick box is provided in this task to indicate which kind of evaluation will be

performed by the rMS and the cMS must select the same evaluation type chosen

by the rMS.

Step 6: Claim the “Evaluate & Decide” task.

In case a full evaluation of the application is necessary, within 365 days* of validating an

application, the rMS shall evaluate the application and draft a PAR in accordance with Article

30(3) and send it together with the SPC through ad hoc communication to the cMSs and to

the applicant.

a. All the cMSs express their position on the draft SPC within 90 day of the receipt

of the draft PAR and SPC from rMS by sending their decision on the agreement

through ad hoc communication to the rMS, the other cMSs and the applicant

using the template from the supporting documents sections below.

b. In case a given cMS agrees with the draft SPC and the PAR (a positive

assessment report), the cMS completes the actions in the “Evaluate & Decide”

page (Figure 20) and renews the authorisation within 30 days of reaching the

agreement in conformity with the agreed SPC and closes the task by approving

the application for the renewal of national authorisation (see section 3.12).

Within 7 days after agreement, SPC should be translated by the applicant in all

applicable languages. The finalised respective language version of the SPC must

be uploaded by the cMS when approving the renewal. (The rMS shall upload

the agreed SPC and the final PAR in R4BP 3 together with any agreed terms

and conditions on the making available on the market or use of the biocidal

product when approving the application for the renewal of national

authorisation.)

Make sure to assign the same expiry date as for the reference product. To find

the expiry date of the reference product go to the related cases tab of your

case’s details page and copy the reference number of the reference product

64

(see point 8 of Figure 7). Search for the reference authorisation using this

number.

c. If you disagree with the draft SPC, send a detailed explanation of the points of

disagreement and the reasons for your position to the rMS, the other cMSs, the

applicant and, where applicable, the authorisation holder through ad hoc

communication. This shall be referred by the rMS to the Coordination Group

without delay (see section 28).

d. If you refuse to grant the authorisation of the BP or want to adjust the terms

and conditions of the authorisation to be granted according to Article 37 of the

BPR, and on the grounds of Article 7 of Regulation (EU) No 492/2014,

communicate a detailed statement of the grounds for seeking a derogation to

the applicant via ad hoc communication and seek an agreement. If the

agreement between the two is not reached, the cMS informs COM via ad hoc

communication who takes the final decision.

*In case a full evaluation of the application is not necessary the rMS will evaluate it within

180 days of validating the application. Please note that in this case step 6(b) of section 13.4

does not apply.


available.


Template agreement/disagreement on SPC.

NA-MRP Mutual recognition in parallel

15.1 Introduction



15.2 Workflow






15.4.1 Steps to be followed by the rMS




3.11).

Complete the actions in the “MSCA accept” page (Figure 17). Check whether the

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65

fee has been paid within 30 days (3a) or not (3b).



b. If the fee has not been paid within 30 days, reject the application and inform via

ad hoc communication the cMS.


18). Validate the application within 30 days of the acceptance date in accordance

with Article 29(2) and (3) of the BPR. The validation includes verifying:

whether the relevant information described in Article 20 of the BPR has been

submitted,

the statement of the applicant that no application for national authorisation of the

same biocidal product for the same use has been submitted to any other MSCA. A

template is provided by ECHA on the website and should be included in the

application by the applicant as a supporting document.

The validation should not include an assessment of the quality or adequacy of the data or

justifications submitted.

a. If the information requirements described above are fulfilled, select “Validate”

complete and proceed with Step 4.


applicant of the additional information that is required for the validation. Through


applicant is created to submit a new IUCLID dossier or other file type.

Set a reasonable period for the submission of the additional information which

should normally not exceed 90 days. Validate the application within 30 days of

receipt of the additional information.


the deadline (see section 3.12) and inform the cMS accordingly through ad hoc

communication (see section 3.10) using the template mentioned in the supporting

documents section below.

c. If the applicant has already submitted an application for national authorisation for

the biocidal product with the same use in another Member State, reject the

application and inform the applicant of the possibility of seeking mutual

recognition.

Step 4 Claim the “Evaluate & Decide” task.

Within 365 days of validating the application, evaluate the application whether an

authorisation can be granted in accordance with Article 19. The following tasks related to

R4BP 3 can be considered during the evaluation:





or other file type and it will stop the clock. Set a reasonable time frame for the

66

submission of the additional information which should normally not exceed 180








the applicant.

e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc

communication (see section 3.10) and provide the opportunity to submit comments

within 30 days (request reply). Finalise the assessment taking into account the

comments provided by the applicant.

f. Within 365 days of validating an application, the rMS shall send draft PAR and SPC

(see section 3.8.2 and 3.10) through ad hoc communication to the cMS and to the

applicant.



of the draft PAR and SPC from rMS by sending the agreement through ad hoc

communication to the rMS, the other cMSs and the applicant. If a cMS expresses

a disagreement with the draft SPC prepared by the rMS, the rMS shall refer the

detailed explanation of the points of disagreement and the reasons for position

received from the cMS to the Coordination Group without delay (see section 28).

b. Following the 90 days, the rMS will take a decision on the national authorisation,

the rMS grants the national authorisation within 30 days and close the task by

approving or not approving the application for the renewal of national

authorisation (see section 3.12). The rMS uploads the agreed SPC and the final

PAR in R4BP 3 together with any agreed terms and conditions on the making

available on the market or use of the biocidal product (see Figure 24 and section

3.8.2).

15.4.2 Steps to be followed by the cMS




3.11).

Complete the actions in the “MSCA accept” page (Figure 17). Check whether the fee has been

paid within 30 days (3a) or not (3b).



b. If the fee has not been paid within 30 days, reject the application and inform via

ad hoc communication the cMS.

Step 3: Claim the ‘Validate’ task (see section 3.8). Complete the actions in the

‘Validation’ page (Figure 18). Select “validate” or “reject” in line with the decision

of the rMS.



67


Within 365 days of validating an application, the rMS shall evaluate the application and draft

a PAR in accordance with Article 30(3) and send it together with the SPC through ad hoc

communication to the cMS and to the applicant. Please check the status of the reference asset

to verify the progress of the application.


of the draft PAR and SPC from rMS by sending decision on the agreement through

ad hoc communication to the rMS, the other cMSs and the applicant (see section

3.8.2).

b. In case a given cMS agrees with the draft SPC , the cMS, completes the actions in

the “Evaluate & Decide” page (Figure 20) and grant the authorisation within 30

days of reaching the agreement in conformity with the agreed SPC and close the

task by approving the application for granting a national authorisation (see section

3.12). Within 7 days after agreement, SPC should be translated by applicant in all

applicable languages (as requested by the cMS). The finalised respective language

version of the SPC must be uploaded by the cMS when approving the authorisation.

(The rMS shall upload the agreed SPC and the final PAR in R4BP 3 together with

any agreed terms and conditions on the making available on the market or use of

the biocidal product when approving the application for granting a national

authorisation (see section 3.8.2)).

Make sure to assign the same expiry date as for the reference product. To find the

expiry date of the reference product go to the related cases tab of your case’s

details page and copy the reference number of the reference product (see point 8

of Figure 7). Search for the reference authorisation using this number.

c. If you disagree with the draft SPC prepared by the rMS, send a detailed explanation

of the points of disagreement and the reasons for your position to the rMS, the

other cMSs, and the applicant through ad hoc communication. This shall be referred

by the rMS to the Coordination Group without delay (see section 28).

d. If you refuse to grant the authorisation of the BP or want to adjust the terms and

conditions of the authorisation to be granted according to Article 37 of the BPR,

communicate a detailed statement of the grounds for seeking a derogation to the

applicant through ad hoc communication and seek to reach an agreement on the

proposed derogations.



NA-MRS Mutual recognition in sequence

16.1 Introduction



16.2 Workflow



68








3.11).



a. If the fee has been paid accept and proceed with Step 4. The applicant will be



automatically notified (see section 3.12). If there are applications for mutual

recognition in sequence in other Member States, inform the other cMSs accordingly

through ad hoc communication (see section 3.10).


18).

Validate the application within 30 days of the acceptance date in accordance with

Article 33(2) of the BPR and proceed with Step 5.


Within 90 days of validating the application,

a. If you agree on the SPC, record your agreement by sending the agreement

through ad hoc communication to the applicant and, if applicable, to the other

cMSs (see section 3.8.2 on how to agree on the SPC).

In case the cMS agree on the SPC, the cMS complete the actions in the “Evaluate

& Decide” page (Figure 20) and grants the authorisations within 30 days of

reaching agreement in conformity with the agreed SPC and closes the task by

approving the application for the national authorisations (see section 3.12). Before

closing the task, upload the agreed SPC in R4BP 3 (see section 3.8.2). Within 7

days after agreement, SPC should be translated by applicant in all applicable

languages (as requested by the cMS). The finalised respective language versions

of the SPC must be uploaded by the cMS when approving the authorisation.





b. If you consider that the BP assessed by the rMS does not meet the conditions laid

down in Article 19 of the BPR, send a detailed explanation of the points of

disagreement and the reasons for your position to the rMS, the other cMSs, and

the applicant through ad hoc communication. This shall be referred by the rMS to




69

the Coordination Group without delay (see section 28).

c. If you refuse to grant the authorisation of the BP or want to adjust the terms and


communicate to the applicant a detailed statement of the grounds for seeking a

derogation through ad hoc communication and seek to reach an agreement on the




Particular case: Mutual recognition in sequence related to

applications submitted under the BPD regime.

16.6 Introduction



The case is related to an application for a national authorisation to the rMS and an application for mutual recognition to cMSs submitted before 1 September 2013.

The reference number (in the R4BP 3 this is the asset number) of the initiating application

for national authorisation can be found in the ‘General’ sub-tab in the ‘Case details’ page of the application for mutual recognition.

The application must contain the translation of the original authorisation in the rMS, SPC in

an editable format in a language accepted by the cMS and relevant documents for each

cMS as referred to in Annex II to "Notes for guidance to applicants for product

authorisation and mutual recognition" (CA-Sept12-Doc.6.2.a –Final.Rev2 -28/01/2013).

16.7 Workflow



The applicant has submitted an application for a national authorisation to the rMS

and an incomplete application for mutual recognition or an intention to submit an

application for mutual recognition after the first authorisation will have been

granted to cMSs before 1 September 2013;

The rMS grants the first authorisation after the 1 September 2013 without prior

transmission of its assessment report and SPC to the cMSs.


Step 1: Claim the “MSCA accept” task (see section 3.8) and complete the actions in the

“MSCA accept” page (Figure 17).

Fees under this step have already being paid at the time of the submission before

the BPR entered into operation.



70

18).

Validate the application within 30 days of the acceptance date in accordance with

Article 33(2) of the BPR and proceed with Step 5.


Within 90 days of validating the application,

a. If you agree on the SPC, record your agreement in R4BP and by sending the

agreement through ad hoc communication to the applicant and, if applicable, to

the other cMSs (see section 3.8.2 on how to agree on the SPC).

In case a given cMS agrees on the SPC (and a positive assessment report), the

cMS completes the actions in the “Evaluate & Decide” page (Figure 20) and grants

the authorisation within 30 days of reaching agreement in conformity with the

agreed SPC and close the task by approving the application for the national

authorisation (see section 3.12). Before closing the task, upload the agreed SPC in

R4BP 3 (see section 3.8.2). Within 7 days after agreement, SPC should be

translated by applicant in all applicable languages (as requested by the cMS). The

finalised respective language versions of the SPC must be uploaded by the cMS

when approving the authorisation.





b. If you consider that the BP assessed by the rMS does not meet the conditions laid

down in Article 19 of the BPR, send a detailed explanation of the points of

disagreement and the reasons for your position to the rMS, the other cMSs, the

applicant and, where applicable, the authorisation holder through ad hoc

communication. This shall be referred to the Coordination Group without delay (see

section 28).



communicate to the applicant a detailed statement of the grounds for seeking a

derogation through ad hoc communication and seek to reach an agreement on the


You can also use the “resubmit task” and this will trigger the need for the applicant

to upload an IUCLID file and an SPC file.



NA-BBP, NA-BBS National authorisation of the same biocidal product

17.1 Introduction



http://echa.europa.eu/documents/10162/21742587/pg_on_bpr_6_national_authorisation_en.pdf



71

Authorisations can be sought in a Member State where a national authorisation according to

the BPD or the BPR has already been granted (authorised, NA-BBS) or an application for

such an authorisation has been submitted (pending, NA-BBP).

The new same biocidal product regulation (EU) 2016/1802, amending Implementing

Regulation (EU) No 414/2013, introduces the possibility to apply for authorisations in a

Member State whether an Union authorisation has already been granted (NA-BBS) or an

application for an Union authorisation has been submitted (NA-BBP).

The Competent Authority document (CA-March15-Doc.4.7) provides guidance on

applications for a same biocidal product of an individual product of a biocidal product family.

17.2 Workflow






17.4.1 NA-BBS National authorisation of same biocidal product (authorised)

Step 1: Claim the ‘MSCA accept’ task.



3.11).



a. If the fee has been paid accept and proceed with Step 4. The applicant will be



will be automatically notified (see section 3.12).


18).

Validate the application within 30 days of the acceptance date. Check whether all information

described in Article 2 of Implementing Regulation (EU) No 414/2013, amended by

Regulation No 2016/1802, has been submitted and the proposed differences concern only

administrative changes (3a) or not (3b).

a. “Validate” and proceed with Step 5, or

b. “Reject application” (see section 3.12)

Step 5: Claim the “Evaluate & Decide” task (Figure 20) and complete the actions.

Within 60 days of validating the application, evaluate whether the biocidal product


72

is identical to the reference product, except for information on administrative

changes according to Implementing Regulation (EU) No 354/2013.

Close the task by approving or not approving the application for the product

authorisation (see section 3.12). Upload the final SPC with your decision.


expiry date of the reference product go to the related cases tab of your case’s details

page and copy the reference number of the reference product (see point 8 of Figure

7). Search for the reference authorisation using this number.

For the reference product a link is given to the same biocidal products under the

related assets/cases as appropriate.


available.

Figure 34: Tracking the reference case or asset of a same biocidal product

17.4.2 National authorisation of same biocidal product (pending, NA-BBP)

For national authorisation of the same biocidal product (pending), the applicant submits an

application for product authorisation (the reference product) to the Member States, creating

the reference case, and simultaneously asks for the authorisation of one or more same

biocidal product(s). When the reference product is authorised the authorisation of the same

biocidal product(s) can be granted. Since the process is not automated the MSCA needs to



73

follow the finalisation of the reference case and continue with this process once the

authorisation of the reference product is granted. Until finalisation of the reference product

authorisation, the authorisation of the same biocidal product cannot be granted.

Follow steps 1-3 of the same biocidal product (authorised) as appropriate. When a decision is

made with regard to the authorisation of the reference product proceed with step 4 and 5.

Please ensure that the decision on authorisation is sent within 60 days from the date of the

decision concerning the related reference product.

NA-ADC National authorisation - Administrative change on request

18.1 Introduction



The possibility to transfer an authorisation to a new holder is listed as an

administrative change in the Changes Regulation (Annex, title 1, section 1,

item 3). However, this type of application must be made through the

procedure ‘transferring a national authorisation’ outlined in section 19.

The possibility to transform a frame formulation into a product family is also

listed as an administrative change in the Changes Regulation (Annex, title 1,

section 1, item 6). However, this type of application must be made through

the procedure ‘Merge of a product authorisation(s) in a family’ outlined

in section 20.

18.2 Workflow

BRC > MAA > EVL






Step 2: Check whether there is a supporting document under the Documents tab which

indicates that you are the rMS and who the respective cMSs are. This information

or the related cases cannot be read from the case details. If the the applicant

made a group submission for change in mutually recognised assets, ECHA will

send an ad hoc communication (attach the supporting document) to all cMS listed

in the supporting document notifying them of the composition of rMS and cMS for

this submission.



3.11).

Complete the actions in the “MSCA accept” page (Figure 17). Check whether the fee has been

paid within 30 days (a) or not (b).

http://echa.europa.eu/documents/10162/21742587/pg_on_bpr_11_changes_en.pdf

http://echa.europa.eu/regulations/biocidal-products-regulation/legislation



74



b. If the relevant fee has not been paid, reject the application (see section 3.12) and

inform the other cMSs of the grounds for the rejection through ad hoc

communication in R4BP 3 (see section 3.10), using the template from the

supporting documents section below.



Within 30 days following receipt of the notification (i. e. following the acceptance step)

a. If you agree, where relevant, amend the authorisation of the biocidal product in

conformity with the agreed change. Approve the application (see section 3.12)

and upload the amended SPC to R4BP 3. This needs to be done by each Member

State where the change applies.

b. if you disagree “do not approve” the application. This needs to be done by each

Member State where the change applies.

NA-TRS Transfer of a national authorisation

19.1 Introduction

Note that this process is an implementation of a notification of administrative change

concerning the transfer of an authorisation to a new holder related to NA assets referred by

the Changes Regulation, Annex, Title 1, Section 1, example 3. However, this type of

application must be made through this specific process type.



Please watch this YouTube video for a description of the process

19.2 Workflow

BRC > MAA > EVL








3.11).




https://youtu.be/2dlCyAaYF7s




75

a. If the fee has been paid accept the application and proceed with Step

4. The applicant will be notified accordingly.

b. If the fee has not been paid, reject the application (see section 3.12).

The applicant will be notified accordingly.



Within 30 days following receipt of the notification (i. e. following the acceptance

step),

a. if you disagree with the transfer of the asset to a new Legal Entity established in

the EEA, select do not approve application in R4BP 3 (see section 3.12).

b. If you agree, where relevant, amend the authorisation of the biocidal product in

conformity with the information. Approve the application in R4BP 3 (see section

3.12) and upload the amended SPC to R4BP 3.

NA-MRG Merge of product authorisations in one product family

20.1 Introduction



The NA-MRG case type in R4BP 3 serves for two purposes:

- The need to amend data in R4BP 3, where several assets should be merged as

part of a family or a single asset should cover different family members.

- The need to apply for a conversion from frame into a family; and

Note that this process is an implementation of a notification of administrative change

concerning the conversion of frame formulation established under the Biocidal Products

Directive 98/8/EC into product family listed as an administrative change in the Changes

Regulation (Annex, title 1, section 1, item 6). However, the creation of the biocidal product

family mast be made through the NA-MRG process type.

This process may also be used in situations where an applicant applied for a frame

formulation under the Biocidal Products Directive 98/8/EC but the authorisation for product

family was granted after 1 September 2013 and the system does not recognise the NA asset

as a product family. In such cases, which are not subject to fees pertaining to the

administrative changes, applicants are advised to contact the relevant MSCA.

20.2 Workflow

BRC > MAA > EVL








76





3.11).


Check whether the fee has been paid within 30 days (a) or not (b).




will be notified accordingly.



Within 30 days following receipt of the notification (i. e. following the acceptance step)

a. Select approve the application if you agree that the assets included for merging

fall within the specifications of the frame formulation established under the

BPD. Each of the assets becomes a family member asset. Upload the amended

SPCs to R4BP 3. Following the approval, frame formulation is transformed into

a product family, the new product family asset will be visible in R4BP 3. If the

NA-MRG application was for a single asset, the product family will only contain

one member asset. The final SPCs for the family and the member assets are

stored in the correct family asset.

b. Select do not approve the application if you consider that the assets included

for merging do not fall within the specifications of the frame formulation

established under the BPD.

As a result of the conversion from frame to family via NA-MRG, a new

asset is created in R4BP 3. From version 3.8 the link between assets

joining a new family are kept even if a new asset number is given to the

newly formed family.

NA-MIC National authorisation - Minor change on request

21.1 Introduction



21.2 Workflow



Please consult this manual of the Biocides Submission Manuals series for a description of





77

the application requirements related to this process.




Step 2: Check the supporting document contained in the application for the full list of the

affected authorisations and respective rMS and cMSs.



3.11).



a. If the fee has been paid, complete the task and move to step 5. The applicant will

be notified accordingly.

b. If the fee has not been paid within 30 days, reject the application (see section

3.12) The applicant will be automatically notified. Inform the cMSs accordingly

through ad hoc communication (see section 3.10) using the template mentioned

in the supporting documents section below.


18).

Validate the application within 30 days of the acceptance date.

The validation shall not include an assessment of the quality or adequacy of the data or


a. If the application complies with Article 5 of the changes regulation, select validate

and complete and proceed with step 6. The applicant will be automatically notified.

b. If the application is deemed incomplete, request additional information from the

applicant using the ‘Request additional info’ functionality (see section 3.9). Set a

reasonable time limit not normally exceeding 45 days for resubmission.

i. Validate the application within 30 days of receipt of the additional

information. If the additional information submitted is sufficient, complete

the task and go to step 6. The applicant will be automatically notified.

ii. Reject the application if the applicant failed to submit the requested

information within the deadline. The applicant will be automatically notified.

Inform the cMSs via ad hoc communication (see section 3.10) using the

template mentioned in the supporting documents section below.



Within 90 days following validation of the application, evaluate the application. The following

tasks related to R4BP 3 can be considered during the evaluation:


78

b. If additional information is needed to perform the evaluation, request additional

information from the applicant using the ‘Request additional info’ functionality (see

section 3.8) and set a reasonable time limit normally not exceeding 45 days for

resubmission. The request will stop the clock for this time limit. Reject the

application (see section 3.12) if the applicant fails to submit the requested

information within the deadline. The applicant will be automatically notified. Inform

the cMSs via ad hoc communication (see section 3.9) using the letter template

from the supporting documents section below.

c. Within 90 days of validating the application, draft the assessment report and send

it, where relevant, together, with the revised SPC to the cMSs and to the applicant

via ad hoc communication (see section 3.10).


a. If, within 45 days following receipt of the updated assessment report and, where

relevant, the revised SPC, the cMSs have not expressed their disagreement, those

Member States shall be deemed to have agreed with the conclusions of the

assessment report and, where relevant, the revised SPC. If cMS expresses a

disagreement with the draft SPC, the rMS shall refer the detailed explanation of

the points of disagreement and the reasons for position received from the cMS to


b. Following the 45 days, amend the authorisation of the biocidal product in

conformity with the agreed change within 30 days. Inform the applicant of the

agreement by approving the application in R4BP 3 (see section 3.12). The rMS

uploads the agreed SPC and updated assessment report in R4BP 3 together with


the biocidal product.


Step 1. Claim the “MSCA accept” task (see section 3.8).

Step 2. Check the supporting document contained in the application for the full list of the


Step 3. Issue an invoice according to Article 80(2) of the BPR and send it to the applicant


3.11).

Step 4. Complete the actions in the “MSCA accept” page (Figure 17).


a. If the fee has been paid, accept the application and move to step 5. The applicant



3.12). The applicant will be notified automatically. Inform the reference and where

relevant other cMSs accordingly through ad hoc communication (see section 3.10)

using the template mentioned in the supporting documents section below.

Step 5. Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure

18).

Select “validate” or “reject” in line with the validation step outcome of the rMS.



79

Step 6. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &


Within 90 days of validating an application, the rMS shall evaluate the application and draft

an assessment report and send it, where relevant, together with the SPC through ad hoc

communication to the cMSs and to the applicant.

a. Within 45 days following receipt of the updated assessment report and, where

relevant, the revised SPC, agree/disagree on the evaluation of the change(s).

Agree/disagree on the SPC by sending your position through ad hoc communication

to the rMS, the other cMSs and the applicant using the template from the

supporting documents sections below. If you disagree with the draft SPC, include

a detailed explanation of the points of disagreement. This shall be referred by the

rMS to the Coordination Group without delay (see section 28). If, within 45 days

following the receipt of the updated assessment, you have not expressed your

disagreement, you are deemed to have agreed with the conclusions of the

assessment report and, where relevant, the revised SPC.

b. In case a given cMS agrees with the draft SPC, the cMS completes the actions in

the “Evaluate & Decide” page (Figure 20) and amend the authorisation within 30

days of reaching the agreement in conformity with the agreed SPC and closes the

task by approving the application for the renewal of national authorisation (see

section 3.12).



and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a

detailed statement of the grounds for seeking a derogation to the applicant via ad

hoc communication and seek an agreement. If the agreement between the two is

not reached, the cMS informs COM via ad hoc communication who takes the final

decision.


available.


Template agreement to act as CA;

Template for agreement/disagreement on SPC.

NA-MAC National authorisation - Major change on request

22.1 Introduction



22.2 Workflow



80







Step 2. Check the supporting document contained in the application for the full list of

the affected authorisations and respective rMS and cMSs.



3.11).






3.12). The applicant will be automatically notified. Inform the cMSs accordingly

through ad hoc communication (see section 3.10) using the letter template from

the supporting documents section below.

Step 5. Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure

18).

Validate the application within 30 days.



a. If the application complies with Article 5 of the changes regulation, select validate

and complete and proceed with step 6. The applicant will be automatically notified.

b. If the application is deemed incomplete, request additional information from the

applicant using the ‘Request additional info’ functionality (see section 3.9). Set a

reasonable period normally not exceeding 90 days for resubmission.


information. If the additional information submitted is sufficient, select

validate, complete the task and go to step 6. The applicant will be



information within the deadline. The applicant will be automatically notified.

Inform the other cMSs via ad hoc communication (see section 3.10) using

the template mentioned in the supporting documents section below.

c. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &

Decide” page (figure 20).




81

Within 180 days following validation of the application, evaluate the application. The following

tasks related to R4BP 3 can be considered during the evaluation:


b. If additional information is needed to perform the evaluation, request additional

information from the applicant using the ‘Request additional info’ functionality (see

section 3.8) and set a reasonable time limit normally not exceeding 90 days for

resubmission. The request will stop the clock for this time limit. Reject the

application (see section 3.12) if the applicant fails to submit the requested

information within the deadline. The applicant will be automatically notified. Inform

the cMSs via ad hoc communication (see section 3.9) using the letter template

from the supporting documents section below.

c. Within 180 days of validating the application, draft the assessment report and send

it, where relevant, together with the revised SPC to the cMSs and to the applicant

via ad hoc communication (see section 3.10)


a. If within 90 days following receipt of the updated assessment report and, where

relevant, the revised SPC, the cMSs have not expressed their disagreement, those

Member States shall be deemed to have agreed with the conclusions of the

assessment report and, where relevant, the revised SPC. If cMS expresses a

disagreement with the draft SPC, the rMS shall refer the detailed explanation of

the points of disagreement and the reasons for position received from the cMS to


b. Following the 90 days, amend the authorisation of the biocidal product in

conformity with the agreed change within 30 days. Inform the applicant of the

agreement by approving the application in R4BP 3 (see section 3.12). The rMS

uploads the agreed SPC and updated assessment report in R4BP 3 together with


the biocidal product.



Step 2. Check the supporting document contained in the application for the full list of the




3.11).






3.12). The applicant will be notified automatically. Inform the reference and where

relevant other cMSs accordingly through ad hoc communication (see section 3.10)

using the template from the supporting documents section below.

82



Within 180 days following validation of the application, the rMS shall evaluate the application

and draft the assessment report and send it, where relevant, together with the SPC through

ad hoc communication to the cMSs and to the applicant.

a. Within 90 days following receipt of the updated assessment report and, where

relevant, the revised SPC, agree/disagree on the evaluation of the change(s).

Agree/disagree on the SPC by sending your position through ad hoc

communication to the rMS, the other cMSs and the applicant using the template

from the supporting documents sections below. If you disagree with the draft SPC,

include a detailed explanation of the points of disagreement. This shall be referred

by the rMS to the Coordination Group without delay (see section 28). If, within 90

days following the receipt of the updated assessment, you have not expressed

your disagreement, you are deemed to have agreed with the conclusions of the

assessment report and, where relevant, the revised SPC.

b. In case a given cMS agrees with the draft SPC, the cMS completes the actions in

the “Evaluate & Decide” page (Figure 20) and amend the authorisation within 30

days of reaching the agreement in conformity with the agreed SPC and closes the

task by approving the application for the renewal of national authorisation (see

section 3.12).



and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a

detailed statement of the grounds for seeking a derogation to the applicant via ad

hoc communication and seek an agreement. If the agreement between the two is

not reached, the cMS informs COM via ad hoc communication who takes the final

decision.


Template agreement to act as CA;


NA-AAT Amendment of National authorisation

23.1 Introduction



Article 48 of the BPR describes the possibility for the MSCA (or COM for Union authorisation-

described in a different process – future UA-AAT) to cancel or amend an existing national

authorisation. This decision is triggered by one of the situations described in section 23.3.

Where the competent authority intends to amend an authorisation, it shall inform the

authorisation holder and give it the opportunity to submit comments or additional

information within a specified time limit. The evaluating competent authority shall take due

account of those comments when finalising its decision.




83

Where the competent authority cancels or amends an authorisation it shall immediately

notify the authorisation holder, the competent authorities of the concerned Member States

and the Commission.

Competent authorities that have issued authorisations under the mutual recognition

procedure for biocidal products for which the authorisation has been cancelled or amended

shall, within 120 days of the notification, cancel or amend the authorisations and shall notify

the Commission accordingly.

In the case of disagreement between competent authorities of certain Member States

concerning national authorisations subject to mutual recognition the procedures laid down

in Articles 35 and 36 of the BPR shall apply.

In case the amendment concerns a product family it must be started from the reference

asset and new SPCs must be provided for all the component of the family.

In case additional data is needed from the applicant, you can use the “New

communication” functionality. This functionality cannot be used to request for

a IUCLID dossier. For a NA-AAT case type, R4BP 3 will only consider the final

SPC uploaded by authorities and any supporting documentation you include in

this case.

23.2 Workflow



An existing national authorisation needs to be amended based on one of the following

situations:

the conditions referred to in Article 19 are not (longer) fully satisfied; or

the authorisation was granted on the basis of false or misleading information; or

the authorisation holder has failed to comply with its obligations under the

authorisation or under the BPR.


Step 1: Choose the asset to be amended, click on “Create new case” (as shown in Figure

11) and select the NA-AAT case type from the drop-down menu. This will create a

task (with a case number) that you can find in the task tab.

Step 2: Claim the task “Evaluate & Decide“.

a. Inform the AH giving the opportunity to comment in 30 days using ad hoc


b. Select the option that reflects your decision on the cancellation of the

authorisation (Approve or Do not approve) under Task details in R4BP 3 (see

section 3.12). Complete the “Evaluate & Decide” task (Figure 20).

Step 3: Notify the authorisation holder (the applicant, if different than the AH), the

Commission and other MSCA (cMS) of the decision taken using ad hoc


Step 4: In case of mutually recognised authorisations, each cMS shall amend the

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authorisation within 120 days of the notification described in step 3 using the same

R4BP 3 process (NA-AAT).

Step 5: In case of disagreement between CA(s) on the amendment of mutually recognised

authorisations, follow the procedure described in section 28.2.

NA-CAT Cancellation of national authorisation

24.1 Introduction



Article 48 of the BPR describes the possibility for the MSCA (or COM for Union authorisation-

described in a different process – future UA-AAT) to cancel or amend an existing national

authorisation. This decision is triggered by one of the situations described in section 21.3.

In case cancellation concerns a member of a family it must be started from the asset of that

member of the family.

24.2 Workflow



An existing national authorisation needs to be cancelled based on one of the following

considerations:

the conditions referred to in Article 19 are not (longer) satisfied; or





Step 1: Choose the asset to be cancelled, click on “Create new case” (as shown in Figure

11) and and select the NA-CAT case type from the drop-down menu. This will

create a task (with a case number) that you can find in the task tab.

Step 2: Claim the task “Evaluate & Decide“.

a. Inform the authorisation holder giving the opportunity to comment in 30 days

using ad hoc communication (see section 3.10)

b. Select the option that reflects your decision on the cancellation of the

authorisation (Approve or Do not approve) under Task details in R4BP 3 (see

section 3.12). Complete the “Evaluate & Decide” task (Figure 20).

Step 3. Notify the authorisation holder (the applicant, if different than the authorisation

holder), the Commission and other MSCA (cMS) of the decision taken using ad hoc


Step 4. In case of mutually recognised authorisations, each cMS shall cancel the




85

authorisation within 120 days of the notification described in the previous step

using the same R4BP 3 process (NA-CAT).

Step 5. In case of disagreement between CA(s) on the amendment of mutually recognised

authorisations, follow the procedure described in section 28.2.

NA-CCL National authorisation cancellation on request

25.1 Introduction



25.2 Workflow

BRC > EVL





Step 1: Claim the “Evaluate & Decide” task (Figure 20).

Step 2: Complete the actions in the “Evaluate & Decide” page:

Approve the application if the (re)submitted information is complete and correct

(see section 3.12) and set the cancellation date.

Please note that the reject and the request additional information options

are only present in this task since R4BP 3 uses the Evaluate & Decide task

to finalise this process. Thes two options should not be used since the BPR

requires the MSCAs to accept the request in any case. Furthermore, no

time period is given in the BPR to finalise this task.

ET-NOT Notification for experiment or test

26.1 Introduction

Please consult the Research and Development chapter of the BPR Practical Guide for a

description of the regulatory requirements and the related process.

26.1 Workflow

BRC > EVL




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86




a. If you consider that the application is incomplete, inform the applicant of the

additional information that is required. Through ‘request additional information’

(see section 3.9) a resubmission task item for the applicant is created. Set a

reasonable period for the submission of the additional information.

b. If you are satisfied that the application meets the information requirements laid

down in Article 56(2) and authorise/restrict (by selecting approve) or ban (by

selecting do not approve) the tests or experiments in line with the criteria in Article

56(3) within 45 days of the “Evaluation started” date.

c. If the CA issues no opinion within 45 days the applicant can start the test or

experiment.

NA-NPF Notification of product in product family for national authorisation

27.1 Introduction



27.2 Workflow

BRC > EVL






Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 20)

a. Check whether the notified product belongs to the related biocidal product family

according to the national authorisation.

b. Request additional information through the ‘request additional information’ item

(see section 3.9); a resubmission task item for the applicant is created. Set a

reasonable period for the submission of the additional information

c. If the submitted information is complete and correct, approve the notification (see

section 3.12); a new asset will be created with the authorisation number having

the suffix subsequent to the last authorised family member. All the family members

with the appropriate authorisation numbers (including the suffix) are shown under

the ‘family information’ of the related biocidal product family’s asset. Ensure you

include the correct authorisation number having the appropriate suffix in the





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decision.

d. Please note that an updated SPC needs to be uploaded before finalising the task

as specified in Figure 21.

e. Select “Do not approve the notification” if the conditions for adding the product

into the product family are not met.

Settlement of disagreements (n/a)

28.1 Pre-conditions

The applicant has submitted

o an application for mutual recognition (either in parallel or in sequence) or

o a notification for placing on the market (simplified authorisation) according to

Article 27(2) or

o an application/notification for minor/major change in relation to national

authorisation (subject to mutual recognition)/simplified authorisations

o an application for renewal of authorisations subject to mutual recognition

through R4BP 3.

According to Article 35(2) of the BPR, only concerned MSs are allowed to start the

process.


As mentioned in section 3.8 this process is not a separate one in R4BP 3 but is relevant for

the finalisation of the above mentioned processes. Therefore, this process is included in the

present manual. The working procedures of the Coordination Group describe how this

process is designed in detail.

The concerned Member State (cMS) shall send the detailed explanation of the points of

disagreement and the reasons for its position at the same time to the reference Member

State (rMS), the other cMSs, the Coordination Group (CG) secretariat, the applicant, and

where applicable, to the authorisation holder.

Before concluding that a formal procedure should be launched, Member States should have

an informal exchange between themselves, keeping ECHA informed.

For sending the disagreement, use the ad hoc communication in R4BP 3 (see section 3.10).

You might select ‘Comments’ in the ‘Topic’ as well as in the ‘Doc. Type’ fields. For the

‘Subject’ field please fill in ‘Referral to CG’. If you decide to also record the informal exchange

in R4BP 3, please use ‘Information to CG on Mutual Recognition issues’ in the ‘Subject’ field.

When sending the ad hoc communication to the rMS, please select the box ‘Reply required’.

In this way, a task item will be created for the rMS and by answering to that, the

communication /agreement can be recorded in R4BP 3.

If an agreement is reached in CG, the rMSs and/or cMSs need to implement the agreement.

If no agreement is reached within the 60-day period, the rMS submits the points of

disagreement to the Commission.

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NE-NOT Notification of an unexpected or adverse effect

national authorisation

29.1 Introduction



29.2 Workflow

BRC > EVL







a. If the application does not contain sufficient information as laid down in Article 47,

to assess whether authorisation needs to be amended or cancelled, request

additional information from the applicant using the ‘Request additional info’

functionality (further information in sections 3.9). Set a reasonable time limit for

the submission of the additional information.

b. Notify competent authorities of other Member States using the ad hoc

communication in R4BP 3 (see section 3.10).

c. Check whether the notified unexpected or adverse effect affects the conditions

under which the national authorisation was granted. Take a decision on whether

the authorisation needs to be amended or cancelled. Close the task selecting one

of the relevant options described in section 3.12.

Step 2. Cancel or amend the respective authorisation using NA-AAT or NA-CAT processes.

In case of amendment upload the final PAR and SPC to R4BP 3.

PP-APP Parallel Trade

30.1 Introduction



30.2 Workflow

BRC > MAA > EVL










89





3.11).

Step 3: Complete the actions in the “MSCA accept“(Figure 17).



a. Complete and proceed with Step 4.

b. Reject the application via R4BP 3.



Evaluate whether the biocidal product fulfils the requirements according to Article

53(3), i.e. is identical to the reference product. Additional information may be

requested via ad hoc communication (see section 3.10) from the MSCA of the MSO

(or the applicant). The MSCA of the MSO has 30 days to provide the requested

information.

Approve or reject the parallel trade permit application via R4BP 3 within 60 days

from the date the fee has been received.

PP-AAT Amendment of parallel trade permit

31.1 Introduction



If a parallel trade permit needs to be amended, the interested MSCA needs to initiate a task

under the case type PP-AAT.

31.2 Workflow



Conditions to amend a parallel trade permit need to be met.


Step 1: Choose the asset to be amended and select the PP-AAT action. This will create a

task (with a case number) that you can find in the task tab. Claim the task

“Evaluate & Decide“.


90

Step 2: Inform the permit holder giving the opportunity to comment in 30 days using ad

hoc communication (see section 3.10)

Step 3: Decide on the amendment of the permit under Task details in R4BP 3 (see section

3.12).

Step 4: Complete the “Evaluate & Decide” task (Figure 20) by selecting “Approve” or “Do

not approve”.

PP-CAT Cancellation of parallel trade permit

32.1 Introduction



If a parallel trade permit needs to be cancelled, the interested MSCA needs to initiate a task

under the case type PP-CAT.

32.2 Workflow



Conditions to cancel a parallel trade permit need to be met.


Step 1: Choose the asset to be cancelled and select the PP-CAT action. This will create a



Step 2: Inform the permit holder giving the opportunity to comment in 30 days using ad

hoc communication (see section 3.10)

Step 3: Decide on the withdrawal of the parallel trade permit under Task details in R4BP

3 (see section 3.12).


not approve”.

SA-APP National authorisation – simplified procedure

33.1 Introduction



33.2 Workflow

BRC > MAA > EVL


http://echa.europa.eu/documents/10162/21742587/pg_on_bpr_10_simplified_authorisation_en.pdf



91








3.11).




a. If the fee has been paid, accept and proceed with Step 4.

b. If the fee has not been paid, reject the application (see section 3.12).

Step 4: Claim the ‘Evaluate & Decide’ task and complete the actions in the ‘Evaluate &

Decide’ page (Figure 20).

a. If you are satisfied that the product meets the conditions laid down in Article 25,

authorise the product within 90 days of the acceptance date. Grant the product

authorisation using the ‘approve application’ function (see section 3.12).

b. If you consider that the application is incomplete, inform the applicant of the

additional information that is required. Through ‘request additional information’

(see section 3.9) a resubmission task item for the applicant is created to submit a

new IUCLID dossier. Through ad hoc communication with request for a reply (see

section 3.10), a task is created for which other files than IUCLID dossiers can be

sent via R4BP 3.

c. Set a reasonable period for the submission of the additional information which

should normally not exceed 90 days. Authorise the product within 90 days of

receipt.


the deadline (see section 3.12).

SA-BBS Simplified authorisation of the same biocidal

product (authorised)

34.1 Introduction



34.2 Workflow


http://echa.europa.eu/documents/10162/14938692/bsm_07_simplified_authorisation_en.pdf


92





Please follow the same steps of section 17.4.1.

SA-BBP Simplified authorisation of the same biocidal product (pending)

35.1 Introduction



35.2 Workflow






In the simplified authorisation of the same biocidal product (pending) procedure, an

applicant submitted an application for a simplified product authorisation (the reference

product) to the Member States, creating the reference case. Other application(s) are

submitted for the simplified authorisation of one or more same biocidal product(s). When

the reference product is authorised the simplified authorisation of the same biocidal

product(s) can be granted. Since the process is not automated the MSCA needs to follow

the finalisation of the reference case and continue with the (pending) process as soon as the

authorisation of the reference product is granted. Until finalisation of the reference product

authorisation, the authorisation of the same biocidal product cannot be granted.

Please follow steps 1-3 of section 17.4.1. When a decision is made with regard to the

authorisation of the reference product, you can proceed with step 4 and 5. Please ensure

that the decision on authorisation is sent within 60 days from the date of the decision

concerning the related reference product.

SA-CAT Cancellation of simplified authorisation

36.1 Introduction



In case cancellation concerns a member of a family it must be started from the asset of that

member of the family.







93

36.2 Workflow



An existing simplified authorisation needs to be cancelled based on one of the following

considerations:

the conditions referred to in Article 25 are not (longer) satisfied; or





Step 1: Choose the asset to be cancelled and select the SA-CAT action. This will create a



Step 2: Inform the simplified authorisation holder giving the opportunity to comment in

30 days using ad hoc communication (see section 3.10)

Step 3: Decide on the cancellation of the authorisation under Task details in R4BP 3 (see

section 3.12).


not approve”.

Step 5: Notify the simplified authorisation holder, the Commission and all other MSCAs of

the decision taken using ad hoc communication (see section 3.10)

Step 6: In case notifications in other MSCA need to be cancelled, each cCA must contact

the ECHA Helpdesk.

SA-AAT Amendment of simplified authorisation

37.1 Introduction



In case the amendment concerns a product family it must be started from the reference

asset and new SPCs must be provided for all the component of the family.

37.2 Workflow



An existing simplified authorisation needs to be amended based on one of the following

situations:


94

the conditions referred to in Article 25 are no longer fully satisfied; or





Step 1: Choose the asset to be amended and select the SA-AAT action. This will create a



Step 2: Inform the simplified authorisation holder giving the opportunity to comment in

30 days using ad hoc communication (see section 3.10)

Step 3: Decide on the amendment of the authorisation under Task details in R4BP 3 (see

section 3.12).


not approve”.

Step 5: Notify the simplified authorisation holder, the Commission and all other MSCAs of

the decision taken using ad hoc communication (see section 3.10)

Step 6: In case notifications in other MSCAs need to be amended, the applicant should be

required to submit new notifications through SN-NOT.

SA-ADC Simplified authorisation administrative change on request

38.1 Introduction



38.2 Workflow

BRC > EVL






Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 20) by checking

whether the submitted information is complete and correct and amend the

authorisation of the biocidal product in conformity with the agreed change.

Step 3: Approve the application (see section 3.12) and upload the amended SPC to R4BP

3.

Step 4: Reject the notification if the submitted information is incomplete or/and incorrect





95

(see section 3.12).

SA-TRS Transfer of a simplified authorisation

39.1 Introduction



Please watch this YouTube video for a description of the process.

39.2 Workflow

BRC > EVL






Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 20) by checking

whether the submitted information is complete and correct and amend the

authorisation of the biocidal product in conformity with the agreed change.

Step 3: Approve the application (see section 3.12) and upload the amended SPC to R4BP

3.

Step 4: Reject the transfer if the submitted information is incomplete or/and incorrect

(see section 3.12).

SA-MIC Simplified authorisation minor change on request

40.1 Introduction



40.2 Workflow

BRC > MAA > EVL





https://youtu.be/2dlCyAaYF7s




96



Within 30 days following receipt of the notification, if you disagree with the

change or the relevant fee has not been paid, reject the case in R4BP 3 (see

section 3.12) and inform the applicant on the grounds for the rejection. Inform

the other cMSs also on the grounds for the rejection through ad hoc

communication in R4BP 3 (see section 3.10), using the template mentioned in




Step 4: Complete the actions in the “Evaluate & Decide” page (Figure 20) by amending

the simplify authorisation of the biocidal product in conformity with the agreed

change. Approve the case (see section 3.12) and upload the amended SPC to

R4BP 3.

Step 5: Notify other MSCA (cMS) of the decision taken using ad hoc communication (see

section 3.10).

Step 6: In case notifications in other MSCAs need to be amended, the applicant should

be required to submit new notifications through SN-NOT.


Template rejection of an application.

SA-MAC Simplified authorisation major change on request

41.1 Introduction



41.2 Workflow

BRC > MAA > EVL






Within 30 days following receipt of the notification, if you disagree with the

change or the relevant fee has not been paid, reject the case in R4BP 3 (see





97

section 3.12) and inform the applicant on the grounds for the rejection. Inform

the other cMSs also on the grounds for the rejection through ad hoc

communication in R4BP 3 (see section 3.10), using the template mentioned in




Step 4: Complete the actions in the “Evaluate & Decide” page (Figure 20) by amending

the authorisation of the biocidal product in conformity with the agreed change.

Approve the case (see section 3.12) and upload the amended SPC to R4BP 3.

Step 5: Notify other MSCA (cMS) of the decision taken using ad hoc communication (see

section 3.10).

Step 6: In case notifications in other MSCAs need to be amended, the applicant should

be required to submit new notifications through SN-NOT.

SA-NPF Notification of product in product family for simplified authorisation

42.1 Introduction



42.2 Workflow

BRC > EVL






Step 2: If the submitted information is correct, go to Step 3 or request further information

otherwise (see section 3.9).

Step 3: Accept the notification or reject it if the submitted information is still incorrect or

incomplete (see section 3.12).

SE-NOT Notification of unexpected or adverse effect for SA

43.1 Introduction






98

43.2 Workflow

BRC > EVL










SN-NOT Notification for placing on the market - simplified procedure

44.1 Introduction



44.2 Workflow

BRC > EVL










Step 4: If a MSCA (other than the eCA) considers that the biocidal product has not been

notified, labelled or does not meet the requirements of Article 25, it may refer the

matter to the Coordination Group without delay (see section 28).






99

UA-APP Union authorisation

45.1 Introduction



45.2 Workflow






The eCA needs to claim the task during the authorisation process and can request further


Step 1: Claim the ‘Validation’ task.



3.11). If the fee is not paid within 30 days, reject the application. Inform ECHA of

the rejection and ask to close the case via ad hoc communication in R4BP 3 (see

section 3.10). Once the application is closed the applicant will be automatically

notified.

Step 3: Complete the actions in the ‘Validation’ page (Figure 18).

Validate the application within 30 days after receiving the task from ECHA

according to BPR Article 43(3). The validation includes verifying whether the

information requirements for biocidal products are fulfilled.



a. If the information requirements are fulfilled, complete the validation task and



applicant what additional information is required for validating the application. Use

‘Request additional information’ (see section 3.9), if you require a new IUCLID

dossier set a reasonable time limit for the submission of the additional information.

This shall normally not exceed 90 days.

c. Validate the application within 30 days of receipt of the additional information in

R4BP 3. Reject the application if the applicant fails to submit the requested

http://echa.europa.eu/documents/10162/21742587/pg_on_bpr_9_union_authorisation_en.pdf

http://echa.europa.eu/documents/10162/14938692/bsm_08_union_authorisation_en.pdf

100

information within the deadline or the information requirements remain

incomplete. The applicant (case owner) will be automatically notified. Inform ECHA

of the rejection through ad hoc communication in R4BP 3 (see section 3.10). Part

of the fees paid by the applicant to the eCA may need to be reimbursed.


(Figure 19).

Evaluate the application within 365 days (BPR Article 44(1)). The following tasks

related to R4BP 3 can be considered during the evaluation:



For ‘stop the clock’ requests request additional information as described in Step 3.



before submitting the PAR and the dossier enters the peer review phase.


the applicant (this step is not yet agreed by all the MSCA).

Step 5: ECHA suggests that no later than 60 days before the end of the 365-day evaluation

period the eCA sends the PAR and the draft SPC to the applicant for a 30-day

commenting period. Reply to the applicant’s comments and adapt the PAR and draft

SPC accordingly if necessary.

Send the results of the evaluation in the form of a PAR together with an annotated

IUCLID dossier. The eCA also submits the draft SPC. According to the “Working

procedures for evaluating an application for Union authorisation” Table 1, the

submission is done via ad-hoc communication in R4BP 3.



UA-APP (WA) Provisional Union authorisation

46.1 Introduction



46.2 Workflow









101


The eCA needs to claim the task during the authorisation process and can request further





3.11). If the fee is not paid within 30 days, reject the application. Inform ECHA of

the rejection and ask to close the case via ad hoc communication in R4BP 3 (see

section 3.10). Once the application is closed the applicant will be automatically

notified.


Validate the application within 30 days after receiving the task from ECHA according to BPR

Article 43(3). The validation includes verifying whether the information requirements for

biocidal products are fulfilled and that the evaluating competent authority has given a

positive opinion in the CAR (please check the CAR uploaded in the R4BP 3 or CIRCA BC page

under the new active folders)



a. If the information requirements are fulfilled, complete the validation task and



applicant what additional information is required for validating the application. Use

‘Request additional information’ (see section 3.9), if you require a new IUCLID

dossier Set a reasonable time limit for the submission of the additional information.

This shall normally not exceed 90 days.

c. Validate the application within 30 days of receipt of the additional information in

R4BP 3. Reject the application if the applicant fails to submit the requested


incomplete. The applicant (case owner) will be automatically notified. Inform ECHA

of the rejection through ad hoc communication in R4BP 3 (see section 3.10). Part

of the fees paid by the applicant to the eCA may need to be reimbursed.

Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page (Figure

19).

Evaluate the application within 365 days (BPR Article 44(1)). The following tasks




For ‘stop the clock’ requests request additional information as described in Step 3.

102



before submitting the PAR and the dossier enters the peer review phase.


the applicant (this step is not yet agreed by all the MSCA).

Step 5: ECHA suggests that no later than 60 days before the end of the 365-day evaluation

period the eCA sends the PAR and the draft SPC to the applicant for a 30-day

commenting period. Reply to the applicant’s comments and adapt the PAR and

draft SPC accordingly if necessary.

Send the results of the evaluation in the form of a PAR together with an annotated

IUCLID dossier. The eCA also submits the draft SPC. According to the “Working

procedures for evaluating an application for Union authorisation” Table 1, the

submission is done via ad-hoc communication in R4BP 3.



UA-MAC Union authorisation major change on request

47.1 Introduction



47.2 Workflow









3.11) within 15 days after receiving the task from ECHA. If the fee is not paid

within 30 days, reject the application. Inform ECHA of the rejection and ask to

close the case via ad hoc communication in R4BP 3 (see section 3.10). Once the

application is closed the applicant will be automatically notified.


Validate the application within 30 days after receiving the task from ECHA

according to BPR Article 43(3). The validation includes verifying whether the

information requirements for biocidal products are fulfilled.





103



a. If the information requirements are fulfilled (Art 5 of the Regulation (EU)

354/2013), complete the validation task and follow on with Step 4.

b. If the information requirements described above are not fulfilled, request additional

information from the applicant using the ‘Request additional information’

functionality (see section 3.9). Set a reasonable time limit for the submission of

the additional information. This shall normally not exceed 90 days.


information. If the additional information submitted is sufficient, select

validate, complete the task and go to step 4. The applicant will be




incomplete. The applicant (case owner) will be automatically notified.

Inform the other cMSs via ad hoc communication (see section 3.10) using

the template mentioned in the supporting documents section below.


(Figure 19).

Evaluate the application within 180 days according with Article 13(4) of Regulation

354/2013). Before sending the PAR and conclusions to ECHA, the following tasks




evaluation using the ‘Request additional information’ functionality (see section

3.9). Set a reasonable period for the submission of the additional information,

which should normally not exceed 90 days in total. Reject the application (see


deadline. The applicant will be automatically notified. Inform the cMSs via ad-hoc

communication.



Amend if necessary the draft SPC generated by the applicant. Send an electronic

copy of the PAR and the SPC to the applicant through ad hoc communication (see


(request reply).

d. Finalise the assessment taking into account the comments provided by the

applicant.

e. Perform a confidentiality claims check by evaluating the justifications submitted by

the applicant.

104

f. Complete the actions in the “Evaluate & Decide” page by by approving or not

approving the application and at the same time upload the final PAR and SPC to

R4BP 3.



Annex I CA agreement v.2

Agreement to act as the Competent Authority under

Regulation (EU) No 528/2012, Regulation (EU) No

354/2013 or Regulation (EU) No 492/2014

The undersigned Competent Authority (CA) hereby agrees to serve as the Competent

Authority in the following evaluation under Regulation (EU) No 528/2012 concerning the

making available on the market and use of biocidal products (Biocidal Products Regulation)

or Regulation (EU) No 354/2013 on changes of biocidal products authorised in accordance

with Regulation (EU) No 528/2012 (Change Regulation), Regulation (EU) No 492/2014

concerning renewal of authorisations of biocidal products subject to mutual recognition*:

Application type (please specify application type):

Applicant/Company UUID:

Signed on behalf of the CA:

Date:

Name:

* Delete as appropriate



105

Title:

CA and contact information:

Annex II SPC agreement

Agreement/Disagreement on Summary of biocidal

Product Characteristics (SPC) under Regulation

(EU) No 528/2012, Regulation (EU) No 354/2013

or under Regulation (EU) No 492/2014

The undersigned Competent Authority (CA) hereby states agreement or disagreement to the

Summary of the biocidal Product Characteristics (SPC) of the following evaluation under Regulation

(EU) No 528/2012 concerning the making available on the market and use of biocidal products

(Biocidal Products Regulation), under Regulation (EU) No 354/2013 on changes of biocidal

products authorised in accordance with Regulation (EU) No 528/2012 (Change Regulation) or

under Regulation (EU) No 492/2014 as regards the rules for the renewal of authorisations of

biocidal products subject to mutual recognition.

Application type:

Applicant:

Case number:

Reference Member State:

Agree Disagree

Summary of the rationale for disagreement:

Signed on behalf of the CA:

Date:

Name:

Title:

CA and contact information:

EUROPEAN CHEMICALS AGENCY

ANNANKATU 18, P.O. BOX 400,

FI-00121 HELSINKI, FINLAND

ECHA.EUROPA.EU