exploring product authorisation, a multidimensional process europene sub reg ue 528 din 2012.pdf ·...
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Exploring Product Authorisation, a Multidimensional Process
Camelia MihaiCefic – European Biocidal Products Forum
APDCR – Seminar on Biocides2nd June 2016Bucharest, Romania
General Principles
• Authorisation needed before placing a biocidalproduct (BP) on the market1
• The same rules as for a single BP apply also for a biocidal product family (BPF)
• The authorisation is granted for max 10 years
1 BP prior to approval of active substance (AS) is subject to national rules
2
Conditions for Granting Authorisation
3
1/09/2015
Before 1/09/2015
Is your supplier on the Article 95 list?
Conditions for Granting Authorisation
4
Active Substance Your supplier is on the Article 95 list/
Technical equivalence proofFor every active substance contained in the biocidal product with reference to active substances already included in the list of approved active substances.
http://echa.europa.eu/regulations/biocidal-products-regulation/technical-equivalence
Conditions for Granting Authorisation
5
• Sufficient efficacy has been proven
• No unacceptable risk for human health, animal health (non-target organisms) and the environment has been identified
Conditions for Granting Authorisation
1 Derogation for PBT/vPvB: Art 19 (5)
Authorisation possible ONLY where not authorising thebiocidal product would result in disproportionate negativeimpacts for society when compared to the risks to humanhealth, animal health or the environment arising from theuse of the biocidal product under the conditions laid down inthe authorisation. (Art 19 (5)).
6
• Art 19 (4) lays down conditions where a BP may not be authorisedfor use by the general public (e.g. category 1,2 carcinogen, mutagen,ED, PBT and vPvB1)
Multidimensional Process
7
Authorisation paths
Multi-AS/
Multi-PT
Post authorisation
options
Multi-trade names
BP
Multidimensional Process
8
Authorisation paths
Multi-AS/Multi-PT
Deadline for applications for authorisation
Multi AS products: the time of approval of the last AS for that PT
Multi-PT products: the date of approval of the last AS/PT combination
Post authorisation
options
Multi-trade names
BP
- Art 89 BPR
- CA-Sept 2013
Doc.6.2.b
Multidimensional Process
9
Authorisation paths
Multi-AS / Multi-PT
Post authorisation
options
Multi-trade namesOne AN - multi-trade names
BP
CA-May 2014Doc.5.6
Multidimensional Process
10
Authorisation
paths
Multi-AS / Multi-PT
Post authorisation
options
Multi-trade names
BP
Simplified Authorisation
National Authorisation
Mutual Recognition
Union Authorisation
Simplified authorisation procedure
11
Facilitates the marketing of products with lower concern –
better profile with regard to HH and ENV
CA-March16-Doc.4.6: Q&A on simplified procedure
•AS on (new) Annex I
•No SoC, no nanomaterial
•Sufficient efficacy
•No need to wear PPE
•Faster process - 90 days evaluation
•No LoA to AS dossier needed
•Notification is sufficient after 1st authorisation
Mutual Recognition in Sequence
12
cMS1
cMS2
cMS3
Biocidal ProductAlready authorised
in the RefMS
RefMS
• Application to be submitted to each of the cMSs after 1st
authorisation in the RefMS• Applicant to provide a
translation of the authorisation in the RefMS
Mutual Recognition in Parallel
13
cMS1
cMS2
cMS3
RefMS
Biocidal ProductNot yet authorised • Application to be submitted
at the same time to the RefMS and the cMSs
• Applicant to inform all MSs who is the RefMS and all other cMS(s)
Mutual Recognition in Parallel
14
30d 30d365d
Evaluation90d
Comments 30d
MSs to inform applicant of fees
Sub
mis
sio
n
Applicantto pay fees
Accept/reject application
Validate
RefMS: Issue draft PAR and draft SPC
AgreementFinal PAR,
EN SPC and other terms
Au
tho
risa
tio
n
Dossier, LoAs, draft EN SPCCA-Sept13-Doc.6.2.d SPC translation – 7 days
Pre-submission consultation with the RefMS
Multidimensional Process
15
Authorisation paths
Multi-AS / Multi-PT
Post
authorisation
options
Multi-tradenames
BP
Notification
Renewal
Changes Regulation
Same Biocidal Product
Biocidal Product
16
Changes Regulation
Same Biocidal Product regulation
Changes regulation
Renewal Renewal
Au
tho
risa
tio
nP
ost
auth
ori
sati
on
Re
new
al
Same Biocidal Product
17
Facilitates easy entry into the market based on existing authorisation
• Derived/duplicate authorisations
• “MR between companies”
• LoA to the reference BP and AS(s)
• Indication of the proposed differences
• Evidence of sameness on all other aspects
• Companies can complement their portfolio
and service without heavy regulatory burden
• Short, simple procedure (30 d) – limited to one MS
• Independent authorisation – own life
Same Biocidal Product
18
• Derived/duplicate authorisations
• “MR between companies”
• LoA to the reference BP and AS
• Indication of the proposed differences
• Evidence of sameness on all other aspects
• Companies can complement their portfolio
and service without heavy regulatory burden
• Short, simple procedure (30 d) – limited to one MS
• Independent authorisation – own life
Facilitates easy entry into the market based on existing authorisation
Changes Regulation
19
• Deals only with changes by the Authorisation Holder
• With the change, the conditions of Articles 19/25 are still met
• For amendments initiated by CAs or COM -
Art 48 BPR applies
Facilitates changes to already authorised products
• For changes due to C&L check:
CA-Nov15-Doc.4.1: Handling changes to C&L and consequences
• When doubts about Minor/major change: enquire with ECHA
Administrative no change
to properties or efficacy
Minor not of purely administrative
nature – requires only a limited re-assessment of properties or
efficacy
Major
Other than administrative/minor New Authorisation
Other than administrative / minor / major
New product… 20
Effo
rt –
pro
ced
ure
, dat
a, f
ees
Notification
Reduced evaluation
“Proportionate” evaluation
Full evaluation
Changes Regulation
Biocidal Product Family
21
• Composition variation (within permitted ranges)without adversely affecting risk and efficacy
• Same active substance(s)
• Similar uses
• Maximum risk and minimum efficacy
• Changes in composition without new application and new authorisation
• Easier to quickly comply with market demands
• Saves time and resources
Facilitates authorisation of a group of closely-related products
Biocidal Product Family
22
All authorisation paths are possible: • National Authorisation• Mutual Recognition• Union Authorisation
Facilitates the placing on the market of new BPs within the ranges of the family, but not explicitly identified in the original authorisation• No notification for variation in composition of PPDs• Notification (30 days before placing on the market)
Facilitates authorisation of a group of closely-related products
Biocidal Product Family
23
• Changes Regulation may be applied
• Same Biocidal Product Regulation may be applied
Facilitates authorisation of a group of closely-related products
Level 1 - Family
Level 2 – Subfamily Meta SPC
Level 3 – IndividualBiocidal Products
Label
BPF – Multidimensional concept
24
BPF – Multidimensional concept
List of individual biocidal products
(by meta SPC)
General information: applies to any individual product
Overall information
meta SPC 1.1
BP
1.1.1.
BP
1.1.2.
meta SPC 1.2
BP
1.2.1.
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LEV
EL 1
LEV
EL 2
LEV
EL 3
Submission - Three-level information
General information Applies to any individual product
Description of the "subfamilies“(by meta SPC)
BPF – Multidimensional concept
26
LEV
EL 1
LEV
EL 2
LEV
EL 3
Authorisation - One SPC for the BPF: the three-level information
• AN: BPF-1
• Authorisation/expiry dates
• R4BP asset ref. number
• Family name
• PTs
• Admin: AH
• manufacturer(s) BP
• manufacturer(s) AS(s)
• Formulation Type(s)
• Family composition ranges
• AN: BPF-1-1
• PT(s)
• Formulation type(s)
• Composition range of the meta SPC(s)
• Common set of H&P statements
• Authorised uses
• Use-specific instructions and directions for use
• Common set of RMMs
• General directions for use valid for all intended uses
• Other information
• AN: BPF-1-1-n • Trade name(s) • Specific composition
• AN: BPF-1
• Authorisation/expiry dates
• R4BP asset ref. number
• Family name
• PTs
• Admin: AH
• manufacturer(s) BP
• manufacturer(s) AS(s)
• Formulation Type(s)
• Family composition ranges
• AN: BPF-1-1
• PT(s)
• Formulation type(s)
• Composition range of the meta SPC(s)
• Common set of H&P statements
• Authorised uses
• Use-specific instructions and directions for use
• Common set of RMMs• General directions for use
valid for all intended uses
• Other information
• AN: BPF-1-1-n • Trade name(s) • Specific composition
Conclusion and outlook
27
• The authorisation of a BP is a multidimensional process
• BPR introduces new opportunities
• BPR introduces new challenges and stricter timelines
• Post authorisation choices allow for a dynamic life of the BP
• A pragmatic use of the BPF concept remains
the best opportunity to decrease the regulatory burden
Conclusion and outlook
28
• Implementation is key
• Need for further guidance and clarity of processes
• Pragmatism and practical considerations need to prevail
• Continued dialogue among all stakeholders
Abbreviations
30
AS: Active Substance SoC: Substance of Concern UA: Union Authorisation
BP: Biocidal Product LoA: Letter of Access NA: National Authorisation
PA: Product Authorisation PPE: Personal protective equipment PPDs: Pigments, perfumesand dyes
ED: endocrine disruptor Ref MS/cMS: Reference/concerned Member State
H&P: Hazard and Precautionary
PBT: Persistent, bioaccumulative, toxic
(EN) SPC: (English) Summary of product characteristics
RMM: Risk mitigation measures
vPvB: very persistent and very bioaccumulative
PAR: Product authorisation report AN: Authorisation number
PT: product type BPF: Biocidal Product Family AH: Authorisation holder
(e)CA: (evaluating) Competent Authority
MR: Mutual Recognition HH: Human HealthENV: Environment