electronic application form data exchange standard 3esubmission.ema.europa.eu/eaf/docs/new...

European Medicines Agency Communications and Networking

02-004-00010 ELECTRONIC

APPLICATION FORM

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electronic Application Form

Data Exchange Standard 3.0

SUPPLEMENTARY SPECIFICATION ANNEX 2 “APPLICATION FOR VARIATION TO A MARKETING

AUTHORISATION” (ITERATION 5)

5.0, CURRENT


02-004-00010 ELECTRONIC APPLICATION FORM

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TABLE OF CONTENTS 1. Introduction......................................................................................................................................3

1.1. How to read this document...................................................................................................................... 3 1.2. Sections Components................................................................................................................................ 4

1.2.1 The Elements Mapping Table ............................................................................................................................. 4 1.2.2 The Business Rules Table .................................................................................................................................. 5 1.2.3 The Element Tree Diagram (ETD)...................................................................................................................... 5

1.3. Restrictions from the Main dictionnary................................................................................................. 6 1.3.1 Rdm:mp-procedure.............................................................................................................................................. 6 1.3.2 Rdm:ingredient .................................................................................................................................................... 6

2. Variation Application Form ............................................................................................................1 2.1. Application ................................................................................................................................................ 1 2.2. MAH Information summary ................................................................................................................... 4 2.3. Product concerned by this application ................................................................................................... 6 2.4. Variations .................................................................................................................................................. 8 2.5. Information, Present & Proposed Changes ......................................................................................... 10 2.6. Type II Variations – new indications – orphan medicinal product information ............................. 11

2.6.1 HAS ORPHAN DESIGNATION BEEN APPLIED FOR FOR THIS MEDICINAL PRODUCT? ................. 11 2.6.2 INFORMATION RELATING TO ORPHAN MARKET EXCLUSIVITY...................................................... 13 2.6.3 Type II variations – Paediatric Requirements.................................................................................................... 17 2.6.4 Type II Variations – Extended Data/Market Exclusivity................................................................................... 21 2.6.5 Annexes: Product information proposals........................................................................................................... 23 2.6.6 Declaration of the Applicant for Type II ........................................................................................................... 24

3. About this Document .......................................................................................................................1 3.1. Document location .................................................................................................................................... 1 3.2. Definitions, Acronyms, and Abbreviations ............................................................................................ 1 3.3. Referenced documents ............................................................................................................................. 1 3.4. Document Approval ................................................................................................................................. 1 3.5. Document history...................................................................................................................................... 1



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1. INTRODUCTION

1.1. How to read this document In association with this document the variation_human_vet.xsd file contains the description of the structure of all the concepts used for this annex. This will enable you to construct a data extraction/generation script to populate the relevant information to/from your systems. The “Chapters” refer to the paragraph number of the paper application form. The “Sections” refer to the paragraph numbering of this document. Some diagrams are too large to describe the whole hierarchy on only one page. Therefore, the diagrams are split in sub sections that might not be in line with the paper document chapters. In order to find your way back in this document when starting from paper document refer to the chapters’ labels and numbering. The information provided in this document focus only on the variation application form information and how it is mapped with the DES 3.0 standard. Description and definition of the DES 3.0 Concepts used in this document can be found in the DES 3.0 supplementary specifications document.



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1.2. Sections Components Each section is split in three components that show different aspects of the DES 3.0 standard applied to the application form.

1.2.1 The Elements Mapping Table This table describes how the mapping between the paper form fields of a specific chapter and the elements of the DES 3.0 Model. The table consists in 4 columns: • Element Id: The id of the field used in business rules. <paragraph>-<numeric order> Ex: 264-1 • Label: The label of the field in the application form sometimes preceded by a chapter numbering. • DES 3.0 Mapping: It is the corresponding mapped-to element in the DES 3.0 model. It contains at

least one mapped-to element. The mapping shows the hierarchy from the root element to the leaf element with the parent-child link represented by the “/” sign.

• RDM Mapping: It is the corresponding mapped-to attribute in the RDM Model. The mapping shows how to get the information in the RDM relational model through links between the technical concepts represented by the “>” sign.

The minimal notation is always “<technical concept parent>/” in the common context and “<mapped-to element>” in the DES 3.0 column. The description of the technical concept parent is in the DES 2.0 supplementary specifications sections 7.1 and 7.2 If there is no mapping, the DES 1.0 element remains in the form specific part of the model. • Remarks: Contains any relevant information concerning the element values, format or business

rules. Colours Text: Tells that the elements are not part of the RDM 3.0 and can be found only in DES 3.0 with no similarity in terms of definition. Text: Tells that there is no existing mapping between the DES 3.0 and RDM 3.0. The missing mapping can be of two kinds.

o “ignored” based on the decision of the RDM team not to map the element o “not mapped”: The RDM 3.0 may contain more or less elements because the DES 3.0 draft came

after the DES 3.0. Text: Tells that the RDM element is an additional linked entity comparing to the DES 3.0 hierarchy. Note: The EUTCT controlled terms used in the RDM 3 are not always published yet. That’s why some of the DES lists only provide a “short-name” which does not directly corresponds to a CTL term id.



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1.2.2 The Business Rules Table This table contains the description of the business rules between the DES 2.0 mapped-to elements of the Element Mapping Table. It is composed of 4 columns. • Rule: The description rule that applies the target elements described normal English. • Field id: Contains the ID’s of the elements involved in the business rule and formulated in logic math

logic. • Source context: the id’s and common path (hierarchy) of the element(s) that trigger(s) the business

rule. (between the “if....then”) The form field may be referenced by its DES 1.0 or DES 2.0 element name depending on the scope of the rule. If a rule depend on another one then the subsequent rule ID will be notes “id.subid” ex: 1.1 • Target Context: the id’s and common path (hierarchy) of the element(s) that are influenced by the

rule (after the “then” of the business rule) Effect may sometime involve an element form another section but it will be then specified by its ID

1.2.3 The Element Tree Diagram (ETD) The data structure constrains are captured in a graphic approach to facilitate le reading and assessment by the business. The model used refers to the one used by W3C (World Wide Web Consortium XML Specification DTD for its publication standard issued in 1998. The model is called “Element Tree Diagram” (ETD) The diagrams of this version reflect the DES 3.0 standard described in the DES 3.0 Supplementary Specifications document. The ETD shows which are the concepts involved in the mapping of all the application form fields in the Element Mapping Table and the hierarchical constrains between them.



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1.3. Restrictions from the Main dictionary The notation for a restricted element is a doted frame line:

1.3.1 Rdm:mp-procedure The rdm:mp-procedure has been restricted to some of its child elements and renamed “var-mp-procedure”

1.3.2 Rdm:ingredient The rdm:ingredient has been restricted to some of its child elements and renamed “ingredient”

rdm:mp-procedure

var-mp-procedure

country procedure-type +

CTLCTL

actor procedure-number

/text

rdm:mp-authorisation

procedure-start-date proposed-date expiry-date acceptance-date wave-number please-specify-information

renewal-date rdm:application

rdm:mp-procedure

/date /date /date/date

/date

/text/text

element

ingredient

low-strength-numerator

/text

low-strength-denominator

/text

strength-numerator-unit strength-denominator-unit

/CTL /CTL

active-substance-form

/CTL

ich-m5-strength-description

/text

overage reference-monograph-standard

/text

Ingredient-origin mrl

/text /CTL

+ingredients

rdm:ingredient

high-strength-numerator high-strength-denominator

/text /text

substance

/CTL

quantity-operator

/CTL

ingredient-role

/text



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2. VARIATION APPLICATION FORM The “<variation-application-form>” is the highest level of the form specific model that represents the paper form. The declaration and annexed documents sections are fully mapped to the Reference Data Model core concepts and common application form concepts (see DES 3.0 supplementary specifications for more info about those concepts).

2.1. Application Element Mapping Table

Common DES 3.0 Context Common RDM Entry point variation-application-form/ Application >

Field Id

Label DES 3.0 Mapping / = Hierarchy relationship

RDM 3.0 Mapping > = relationship link

Remark /Value/Type/rule/format

21-1 HUMAN domain Domain CTL > term id Value=”human use” 21-1 VETERINARY domain Domain CTL > term id Value=”veterinary use” 21-2 NATIONAL AUTHORISATION IN MRP var-mp-procedure/procedure-type/short-name mp-procedure > Procedure Type CTL > term id Value=”National Authorisation in MRP” 21-3 MRP variation number var-mp-procedure/procedure-number mp-procedure > procedure number 21-2 COMMUNITY AUTHORISATION var-mp-procedure/procedure-type/short-name mp-procedure > Procedure Type CTL > term id Value= “Community authorisation” 21-2 NATIONAL AUTHORISATION ONLY var-mp-procedure/procedure-type/short-name mp-procedure > Procedure Type CTL > term id Value= “National authorisation only”

21-4 Reference Member state var-mp-procedure/country/short-name var-mp-procedure/country/term-id

Not mapped mp-procedure > role > country CTL > term id

21-5 Concerned Member states var-mp-procedure/rdm:mp-authorisation/country /short-name var-mp-procedure/rdm:mp-authorisation/country /term-id

Not mapped procedure use > role > country CTL > term id

Type of application 21-6 Type 1 a IN application-type/short-name Var Type Summary CTL > term id Value= “Type 1 a IN” 21-6 Type 1A application-type/short-name Var Type Summary CTL > term id Value= “Type 1A” 21-6 Type 1B foreseen application-type/short-name Var Type Summary CTL > term id Value= “Type 1B foreseen” 21-6 Type 1B unforeseen application-type/short-name Var Type Summary CTL > term id Value= “Type 1B unforeseen” 21-6 Type II application-type/short-name Var Type Summary CTL > term id Value= “Type II” 21-6 Type II art 23 application-type/short-name Var Type Summary CTL > term id Value= “Type II art 23” -



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21-7 Simple variation variation-grouping/ short-name Var Grouping CT > /term id Value= “Simple variation” 21-7 Grouping variation variation-grouping/ short-name Var Grouping CT > /term id Value= “Grouping variation” 21-7 Including a line extension variation-grouping/ short-name Var Grouping CT > /term id Value=” grouping variation Including a line a-

extension“ 21-7 Worksharing variation-grouping/ short-name Var Grouping CT > /term id Value== “Worksharing” Change(s) concerns(s) 21-8 Indication change-concerns/short-name Var Domain Summary CTL > term id Value= “Indication” 21-8 Pediatric indication change-concerns/short-name Var Domain Summary CTL > term id Value=“Pediatric indication” 21-8 Safety change-concerns/short-name Var Domain Summary CTL > term id Value= “Safety” 21-8 Following urgent safety restriction change-concerns/short-name Var Domain Summary CTL > term id Value= “Following urgent safety restriction” 21-8 Quality change-concerns/short-name Var Domain Summary CTL > term id Value= “Quality” 21-8 Annual variation fir human influenza vaccine change-concerns/short-name Var Domain Summary CTL > term id Value= “Annual variation for human influenza

vaccine” 21-8 Non-food producing target species change-concerns/short-name Var Domain Summary CTL > term id Value= “Non-food producing target species” 21-8 other change-concerns/short-name Var Domain Summary CTL > term id Value= “other”

Business rules table

Rule fields id Source Context Target context If domain is "human" then "non-food producing market" may not be selected

If 21-1 then not21- 8 (21-1) domain=”human use” (21-8) change-concerns/short-name=”“Non-food producing target species”

if "veterinary" then not "Annual variation for human influenza vaccine"

If 21-1 then not 21-8 (21-1) domain=”human use” (21-8) change-concerns/short-name=”“Pediatric indication”

if "veterinary" then not "Paediatric indication" If 21-1 then not 21-8 (21-1) domain=”veterinary use” (21-8) change-concerns/short-name=“Annual variation for human influenza vaccine”

if "National in MRP" then “MRP variation number” is mandatory

If 21-2 then 21-3 (21-2) var-mp-procedure/procedure-type/short-name="National in MRP" (21-3) var-mp-procedure/procedure-number

if "National in MRP" then “Reference Member State” is mandatory

If21-2 then21- 4 (21-2) var-mp-procedure/procedure-type/short-name ="National in MRP" (21-4) var-mp-procedure/country/term-id

if "National in MRP" then “Reference Member State” is unique and “Concerned Member State” is mandatory

If 21-2 then 21-4 and 21-5

(21-2) var-mp-procedure/procedure-type/short-name ="National in MRP" (21-4) var-mp-procedure/country/term-id AND (21-5) var-mp-procedure/rdm:mp-authorisation/country /term-id

if "National procedure" then “Reference Member State” is empty

If 21-2 then not 21-4 (21-2) var-mp-procedure/procedure-type/type="National procedure" (21-4) var-mp-procedure/country/term-id



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Rule fields id Source Context Target context if "community authorisation" and "Worksharing" then “Reference Member State” is "EMA" and “Concerned Member State” is mandatory

If 21-2 and 21-7 then 21-4 and 21-5

(21-2) var-mp-procedure/procedure-type/type="National procedure" AND (21-7 /variation-grouping/short-name=“Worksharing”

(21-4) var-mp-procedure/country/term-id AND (21-5) var-mp-procedure/rdm:mp-authorisation/country /term-id

if "community authorisation" and single variation" then 4 is empty and 5 in "NONE"

If 21-2 and 21-7 then 21-4 and 21-5

(21-2) var-mp-procedure/procedure-type/type=" community authorisation" AND (21-7 variation-grouping/short-name=“single variation”

(21-4) var-mp-procedure/country/term-id = <”EMA”> AND (21-5) var-mp-procedure/rdm:mp-authorisation/country /term-id =<”NONE”>

if "grouping of variation “then no "single variation"

If 21-7 then not 21-7 (21-7 variation-grouping/short-name=“grouping” (21-7) variation-grouping/short-name =“single variation”

if "Paediatric indication" then "type II art 29" is mandatory

If 21-8 then 21-6 (21-8) change-concerns/short-name =“Paediatric indication” (21- 6) application-type/short-name

Element Tree Diagram

variation-application-form

var-mp-procedure application-type Variation-grouping change-concerns + + +

CTLCTLCTL



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2.2. MAH Information summary Element mapping table Common DES 3.0 Context Common RDM Entry point variation-application-form/ Application

Field Id



Remark Type/rule/format

- 22-9 Name and address of MA holder applicant/rdm:role Role > Role CTL > term id Value=”Marketing

Authorisation Holder” - applicant/rdm:role /party-type Role > Party > Party Type CTL > term -d Value=“Organisation” applicant/rdm:role /name Role > Party > Organisation >Name - applicant/rdm:role /rdm:contact-details/address Role > Party > Contact Details > address line 1 (to address line 5) applicant/rdm:role /rdm:contact-details/city Role > Party > Contact Details > city applicant/rdm:role /rdm:contact-details/post-code Role > Party > Contact Details > post-code applicant/rdm:role /rdm:contact-details/country/short-name Not mapped applicant/rdm:role /rdm:contact-details/country/term-id Role > Party > Contact Details > Country CTL > term id 22-10 Name and address of Contact contact-person/rdm:role Role > Role CTL > termid - contact-person /rdm:role /party-type Role > Party > Party Type CTL Value=“Person” - contact-person /rdm:role /given-name Role > Party > Person > given-name contact-person /rdm:role /family-name Role > Party > Person > family name - contact-person /rdm:role /rdm:contact-details/address Role > Party > Contact Details > address line 1 (to address line 5) contact-person /rdm:role /rdm:contact-details/city Role > Party > Contact Details > city contact-person /rdm:role /rdm:contact-details/post-code Role > Party > Contact Details > post-code contact-person /rdm:role /rdm:contact-details/country/short-name Not mapped contact-person /rdm:role /rdm:contact-details/country/term-id Role > Party > Contact Details > Country CTL > term id



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Business rules table Rule fields id Source Context Target context “Name and address of MA holder” is mandatory with specific values

22-9 - applicant/rdm:role /name applicant/rdm:role /party-type=”Organisation” applicant/rdm:role /rdm:contact-details/address applicant/rdm:role /rdm:contact-details/post-code applicant/rdm:role /rdm:contact-details/country/term-id

“Name and address of Contact” is mandatory with specific values

22-10 - contact-person /rdm:role /party-type=”Person” contact-person /rdm:role /given-name contact-person /rdm:role /family-name contact-person /rdm:role /rdm:contact-details/address contact-person /rdm:role /rdm:contact-details/post-code contact-person /rdm:role /rdm:contact-details/country/term-id

Element Tree Diagram The rdm:party concept has been merged with the rdm:role to simplify the mapping. .

variation-application-

applicant contact-person

rdm:role rdm::role



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2.3. Product concerned by this application Common DES 3.0 Context Common RDM Entry point variation-application-form/concerned-products/pharmaceutical-products Application

Field Id



23-1 (invented names) authorisations/authorisation/invented-name Medicinal product > Medicinal Product Group > invented name 23-2 Active substance(s) ingredients/ingredient/substance/term-id Medicinal product > Pharmaceutical Product > Ingredient > Substance CTL > term id

Medicinal product > Pharmaceutical Product > Ingredient > Ingredient Role CTL > term id (1) (1) term id for ”Active substance”

23-3 Pharmaceutical form pharmaceutical-product/pharmaceutical-form/dosage-form/term-id

Medicinal product > Pharmaceutical Product/pharmaceutical Dose Form CTL > term id

23-4 Strength ingredients/Ingredient/low-strength-numerator ingredients/Ingredient/low-strength-denominator ingredients/Ingredient/high-strength-numerator ingredients/Ingredient/high-strength-denominator ingredients/Ingredient/quantity-operator/term-id ingredients/Ingredient strength-numerator-unit/term-id ingredients/Ingredient strength-denominator-unit/term-id

Medicinal product > Pharmaceutical Product > Ingredient > low strength numerator Medicinal product > Pharmaceutical Product > Ingredient > low strength denominator Medicinal product > Pharmaceutical Product > Ingredient > high strength numerator Medicinal product > Pharmaceutical Product > Ingredient > high strength denominator Medicinal product > Pharmaceutical Product > Ingredient > Quantity Operator CTL > term id Medicinal product > Pharmaceutical Product > Ingredient > Unit CTL > term id Medicinal product > Pharmaceutical Product > Ingredient > Unit CTL > term id

23-5 MA holder name authorisations/authorisation/authorisation-holder Role > Party > Organisation > Name 23-6 MA number(s) authorisations/authorisation/authorisation-number Medicinal Product > MP Authorisation > authorisation number 23-7 Member state /community authorisations/authorisation/country/term-id Medicinal product > MP Authorisation > Country CTL > term id 23-8 MRP Variation Number authorisations/authorisation/mrp-variation-number Medicinal product > MP Procedure > procedure number

Business rules table Rule fields id Source Context Target context “(invented names)” is mandatory 23-1 - - Active substance(s) is mandatory with specific values 23-2 - ingredients/Ingredient/ingredient-role=”Active substance” Pharmaceutical form is mandatory 23-3 - - Strength is mandatory 23-4 - - MA holder name is mandatory 23-5 - - MRP Variation Number is mandatory 23-8 - - Member state /community is mandatory 23-7 - -



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Element tree diagram The ingredient element is a restriction of the rdm:ingredient.

eu-application-form

+

+


concerned-products

pharmaceutical-products

pharmaceutical-product

ingredients

+

authorisations

authorisation

+

authorisation-numbers

authorisation-number +

/text

pharmaceutical-form

ingredient

country invented-name authorisation-holder mrp-variation-number

/CTL /text /text /text

dosage-form

/CTL



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2.4. Variations Element mapping table Common DES 3.0 Context Common RDM Entry point variation-application-form/variation-items Application

Field Id




- Variation included in this application - 24-1 Classification variation-item/variation-classification/type No mapped - Classification description variation-item/variation-description No mapped - - variation-item/variation-item-type/type No mapped 24-2 Procedure type variation-item/procedure-tyoe No mapped 24-3 Art 5 variation-item/is-article5 No mapped 24-3 Implementation. date variation-item/implementation-date No mapped 24-5 Present variation-item/present-description Application Proposal > present product info 24-6 Proposes variation-item/proposed-description Application Proposal/ > proposed product info

Business rules table Rule fields id Source Context Target context The classification is mandatory 24-1 - - The procedure type is mandatory 24-2 - - Implementation. Date is mandatory is procedure type is of type IA If 24-2= “IA” then 24-3 is

mandatory (24-2) variation-item/procedure-tyoe (24-3) variation-item/-implementation-date

Present is mandatory 24-5 - - Proposed is mandatory 24-6 - -



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Element Tree Diagram The Present and proposed values are children of the variation-item element in order to keep the link between each instance of a variation classification and the corresponding changes .

variation-items

variation-item

+

variation-classification variation-item-type procedure-type variation-description present-description proposed-description Implementation-date Is-article5

/CTL /text /text /text /Date /text “Yes” | “No”

/CTL /text

eu-application-form




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2.5. Information, Present & Proposed Changes Element mapping table Common DES 3.0 Context Common RDM Entry point variation-application-form/ Application

Field Id Label DES 3.0 Mapping / = Hierarchy relationship



25-1 PRECISE SCOPE AND BACKGROUND FOR CHANGE, AND JUSTIFICATION FOR GROUPING, WORKSHARING AND CLASSIFICATION OF UNFORESEEN CHANGES (if applicable)

/background-for-change scope background

25-2 OTHER APPLICATIONS /other-applications Other application

Business rules table Rule fields id Source Context Target context “PRECISE SCOPE AND BACKGROUND” is mandatory

25-1 - -

Element tree diagram


other-applications background-for-change /text /text

eu-application-form



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2.6. Type II Variations – new indications – orphan medicinal product information 2.6.1 HAS ORPHAN DESIGNATION BEEN APPLIED FOR THIS MEDICINAL PRODUCT?

Element Mapping Table Common DES 3.0 Context Common RDM Entry point variation-application-form/type2-variation-orphan-medicnal-product/rdm:orphan-designation/ Application >

Field Id


RDM 3.0 Mapping > = Foreign key relationship


HAS ORPHAN DESIGNATION BEEN APPLIED FOR THIS MEDICINAL PRODUCT?

-

261-1 No rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Orphan Designation > has od applied value=”Regulation” Value=“Yes”” Value=”141/2000” Value=”5.1” Value=“No”

261-2 Yes rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Orphan Designation > has od applied Value=”Regulation” Value=“yes”” Value=”141/2000” Value=”5.1” Value=“Yes”

261-3 Orphan Designation Procedure Number rdm:od-procedure/odp-number od procedure number 261-4 Pending rdm:od-procedure/od-authorisation/oda-status / short- name Authorisation Status CTL > term id Value=”Pending” 261-5 Orphan Designation Granted rdm:od-procedure/od-authorisation/oda-status / short- name Authorisation Status CTL > term id Value=”Granted” 261-6 Date rdm:od-procedure/od-authorisation/oda-date od status date Format: yyyy-mm-dd 261-7 Based on the criterion of "significant

benefit" Is _significant-benefit is based significant benefit

261-8 Number in the Community Register of Orphan Medicinal Products

rdm:od-procedure/od-authorisation/oda-eu-register-number od community reg number

261-9 Attach copy of the Designation Decision rdm:od-procedure/od-authorisation / attachment/attachment-type/ Ignored. term-id= “5.18”



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Business rules table Rule fields id Source Context Target context The legislation element is mandatory with specific values for the child elements

261-1, 261-2 rdm:legislation:leg-type=”Regulation” rdm:legislation:leg-applies=“yes” | “No” rdm:legislation /legislation-eu-code=”141/2000” rdm:legislation /leg-article/leg-article-number=”5.1” rdm:legislation /leg-article:leg-applies=”yes” | “No”

Element Mapping Table

rdm:legislation

rdm:orphan-designation

rdm:od-procedure

od-authorisation


?

type2-variation-orphan-medicnal-product

rdm:attachment

eu-application-form



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2.6.2 INFORMATION RELATING TO ORPHAN MARKET EXCLUSIVITY Element Mapping Table Common DES 3.0 Context Common RDM Entry point variation-application-form/type2-variation-orphan-medicnal-product/rdm:orphan-designation/od-market-exclusivity Application

Field Id Label DES 3.0 Mapping / = Hierarchy relationship



Has any medicinal product been designated as an Orphan medicinal product for a condition relating to the new indication proposed in this variation application?

-


Orphan Designation > has mp designated orphan Value=”Regulation” Value=”No” Value =”141/2000” Value =”8.1” Value =” “No”

262-2 yes m:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Orphan Designation > has mp designated orphan Value=”Regulation” Value=”Yes” Value =”141/2000” Value =”8.1” Value =”Yes”

262-3 Please specify the EU Orphan Designation Number(s)

od-procedure-numbers/od-procedure-number Orphan Designation > OD Number > eu od number

has any of the designated Orphan medicinal product(s) been granted a marketing authorisation in the EU

-

262-4 yes rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Orphan Designation > has od mp granted ma Value =”Regulation” Value =”Yes” Value =”141/2000” Value=”5.9” Value =”Yes”


Orphan Designation > has od mp granted ma Value =”Regulation” Value =”Yes” Value =”141/2000” Value=”5.9” Value = “No”



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262-6 Name, strength, pharmaceutical form of the authorised product

rdm:reference-medicinal-product/medicinal-product-group/medicinal-product/rdm:pharmaceutical-product/... invented-name pharmaceutical-dose-form/term-id ingredient/low-strength-numerator ingredient/low-strength-denominator ingredient/high-strength-numerator ingredient/high-strength-denominator ingredient/quantity-operator/term-id strength-numerator-unit/term-id strength-denominator-unit/term-id

Reference Medicinal Product > Medicinal Product >... medicinal product name Pharmaceutical Product > Pharmaceutical Dose Form CTL > term id Pharmaceutical Product > Ingredient > low strength numerator Pharmaceutical Product > Ingredient > low strength denominator Pharmaceutical Product > Ingredient > high strength numerator Pharmaceutical Product > Ingredient > high strength denominator Pharmaceutical Product > Ingredient > quantity operator CTL > term id Pharmaceutical Product > Ingredient > Unit > term id Pharmaceutical Product > Ingredient > Unit > term id

262-7 Name of the marketing authorisation holder rdm:reference-medicinal-product/medicinal-product-group/medicinal-product/rdm:mp-authorisation/... authorisation/authorisation-holder

Reference Medicinal Product > Medicinal Product > Mp Authorisation > Role > party > organisation > name

party-type=”organisation”

262-8 Marketing authorisation number(s) rdm:reference-medicinal-product/medicinal-product-group/medicinal-product/rdm:mp-authorisation/... authorisation-number

Reference Medicinal Product > Medicinal Product > MP Authorisation > authorisation number

262-9 Date of authorisation rdm:reference-medicinal-product/medicinal-product-group/medicinal-product/rdm:mp-authorisation/... authorisation-date

Reference Medicinal Product > Medicinal Product > MP Authorisation > authorisation date

If yes, is the medicinal product, subject of this application, considered as “similar” to any of the authorised Orphan medicinal product(s)? (as defined in Article 3 of Commission Regulation (EC) No 847/2000)

-

262-10 yes rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Orphan Designation > is mp similar to authorised Value =”Regulation” Value =”Yes” Value =”847/2000” Value=”3” Value =”Yes”


Orphan Designation > is mp similar to authorised Value =”Regulation” Value =”Yes” Value =”847/2000” Value=”3” Value = “No”



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Business rules table Rule fields id Source Context Target context “Has any medicinal product been designated as an Orphan medicinal product for a condition relating to the new indication proposed in this variation application” must be answered yes or no and contains specific values.

262-1, 262-2, rdm:legislation:leg-type=”Regulation” rdm:legislation:leg-applies=”Yes” rdm:legislation /legislation-eu-code=”141/2000” rdm:legislation /leg-article/leg-article-number=”8.1” rdm:legislation /leg-article:leg-applies=”Yes” | “No”

“Has any of the designated Orphan medicinal product(s) been granted a marketing authorisation in the EU” must be answered yes or no and contains specific values.

If “262-2” = TRUE” then 262-4 OR 262-5 must be selected

262-2: legislation/leg-article:leg-applies=”Yes”

rdm:legislation:leg-type=”Regulation” rdm:legislation:leg-applies=”Yes” rdm:legislation /legislation-eu-code=”141/2000” rdm:legislation /leg-article/leg-article-number=”5.9” rdm:legislation /leg-article:leg-applies=”Yes” | “No”

“If yes, is the medicinal product, subject of this application, considered as “similar” to any of the authorised Orphan medicinal product(s)? (As defined in Article 3 of Commission Regulation (EC) No 847/2000)” must be answered yes or no and contains specific values.

If 262-5 = TRUE then 262-10 OR 262-11 must be selected

262-5: legislation/leg-article:leg-applies=”Yes”

rdm:legislation:leg-type=”Regulation” rdm:legislation:leg-applies=”Yes” rdm:legislation /legislation-eu-code=”847/2000” rdm:legislation /leg-article/leg-article-number=”3” rdm:legislation /leg-article:leg-applies=”Yes” | “No”



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Element Tree Diagram In the context of the market exclusivity, any granted orphan designation for one of the indication of the current applied product is mapped to the reference medicinal product depending on the legislation element (article 5.9 of Regulation (EC) 141/2000). The information about any marketing authorisation (article 8.1 of Regulation (EC) 141/2000) for an orphan designated product is mapped to the reference medicinal product depending on the corresponding legislation element.

rdm:reference-medicinal-product rdm:legislation


*od-procedure-numbers

+type2-variation-orphan-medicnal-product

rdm:orphan-designation

od-market-exclusivity

*+

eu-application-form



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2.6.3 Type II variations – Paediatric Requirements Note: For human medicinal products only; section to be completed only for variations concerning a new indication or for variations related to PIP implementation. Note: The notion of ‘global marketing authorisation’ as stated in Article 6(1)2nd subparagraph of Directive 2001/83/EC, as amended, should be taken into account for products belonging to the same(footnote 6) marketing authorisation holder Element Mapping Table Common DES 3.0 Context Common RDM Entry point variation-application-form/type2-variation-pediatric/ Application >

Field Id




ARTICLE 8 OF THE PAEDIATRIC REGULATION APPLIES TO THIS VARIATION APPLICATION, SINCE

- -

263-1 The application relates to a new indication for an authorised medicinal product, which is protected by a supplementary protection certificate under Regulation (EEC) No 1768/92

rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies rdm:legislation /leg-usage

Paediatric Designation > Paed Regulation App CTL Value= “Regulation” Value=”Yes" Value=”1901/2006” Value=”8” Value=”yes” Value=”supplementary protection”

263-2 The application relates to a new indication for an authorised medicinal product, which is protected by a patent which qualifies for the granting of the supplementary protection certificate


Paediatric Designation > Paed Regulation App CTL Value= “Regulation” Value=”Yes" Value=1901/2006 Value=”8” Value=”yes” Value=”patent protection”

263-3 This application relates to a previous/ongoing/parallel procedure which triggered the Article 8 requirement.


Paediatric Designation > Paed Regulation App CTL Value= “Regulation” Value=”Yes" Value=”1901/2006” Value=”8” Value=”yes” Value=”other triggering procedure”

263-4 This application does not fall within the scope of the paediatric regulation

rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Paediatric Designation > Paed Regulation App CTL Value= “Regulation” Value=”Yes" Value=”1901/2006” Value=”8” Value=”No””



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263-5 THIS APPLICATION RELATES TO A MEDICINAL PRODUCT TO WHICH ARTICLE 7 OF THE PAEDIATRIC REGULATION APPLIED


Paediatric Designation > Paed Regulation App CTL Value= “Regulation” Value=”Yes" Value=”1901/2006” Value=”Article 7” Value=”Yes””

263-6 THIS APPLICATION RELATES TO A NEW INDICATION FOR A PAEDIATRIC USE MARKETING AUTHORISATION (PUMA).


Paediatric Designation > Paed Regulation App CTL Value= “Regulation” Value=”Yes" Value=”1901/2006” Value=”30” Value=”yes”

263-7 THIS APPLICATION RELATES TO PAEDIATRIC STUDIES SUBMITTED ACCORDING TO ARTICLE 45 OR 46 OF THE PAEDIATRIC REGULATION.


Paediatric Designation > Paed Regulation App CTL Value= “Regulation” Value=”Yes" Value=”1901/2006” Value=”45” | “46” Value=”yes”

THIS APPLICATION INCLUDES: - - 263-8 PIP Decision Number(s): rdm:paediatric-designation/paediatric-designation-plan/...

pip-decision-number Paediatric Designation > art 7 pip decision number

263-9 Waiver Decision Number rdm:paediatric-designation/pediatric-designation-plan/rdm:waiver/... waiver-decision-number waiver_type

Paediatric Designation > art 7 product waiver number waiver-type=”product specific”

263-10 Waiver Decision Number rdm:paediatric-designation/pediatric-designation-plan/rdm:waiver/... waiver-decision-number waiver_type

Paediatric Designation > art 7 class waiver number waiver-type=”class”

263-11 A copy of pip/waiver decision is to be included in module 1.10

rdm:paediatric-designation/pediatric-designation-plan/rdm:attachment

Ignored. value = “1.10”

HAS THIS APPLICATION BEEN SUBJECT TO PIP COMPLIANCE VERIFICATION?

- -

263-11 Yes pip-verification/rdm:legislation:leg-type pip-verification/rdm:legislation:leg-applies pip-verification/rdm:legislation /legislation-eu-code pip-verification/rdm:legislation /leg-article/leg-article-number pip-verification/rdm:legislation /leg-article:leg-applies

Paediatric Designation > subject to pip compliance Value= “Regulation” Value=”Yes" Value=”1901/2006” Value=”23.2.a” Value=”Yes"



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263-12 No pip-verification/rdm:legislation:leg-type pip-verification/rdm:legislation:leg-applies pip-verification/rdm:legislation /legislation-eu-code pip-verification/rdm:legislation /leg-article/leg-article-number pip-verification/rdm:legislation /leg-article:leg-applies

Paediatric Designation > subject to pip compliance Value= “Regulation” Value=”Yes" Value=”1768/92” Value=”23.2.a” Value=”No"

263-13 PDCO compliance Opinion Number rdm:paediatric-designation/pip-verification/document-reference/... document-reference reference-type

Paediatric Designation > pdco opinion number reference-type=”PDCO”

263-14 National competent authority/EMEA document reference

rdm:paediatric-designation/pip-verification/document-reference/... document-reference reference-type

Paediatric Designation > nca emea doc reference reference-type =”National” or “EMEA”

263-15 Please provide the overview table of PIP results in Module 1.10

rdm:paediatric-designation/pip-verification/Attachment/short-name Ignored. Value = “Pip results”

Business rules table Rule fields id Source Context Target context if there is a “paediatric indication:” only one selection is authorised for points 263-1 to 263-7 with specific values

21-8 = “Paediatric indication” then XOR (263-1 to 263-7) = TRUE

(21-8) change-concerns/type= “Paediatric indication” rdm:legislation:leg-type=” Regulation” rdm:legislation:leg-applies=”Yes” rdm:legislation/legislation-eu-code=”1901/2006” | “1768/92” rdm:legislation/leg-article/leg-article-number=” 8” | “7” | “30” | “46” | “45” rdm:legislation/leg-usage=” supplementary protection” | ”patent protection” | “other triggering procedure” rdm:legislation/leg-article:leg-applies= yes”|”no”

if there is a “paediatric indication:” only one selection is authorised for section “THIS APPLICATION INCLUDES:”

21-8 = “Paediatric indication” then XOR (263-8 to 263-10) = TRUE

(21-8) change-concerns/type= “Paediatric indication” (263-8 to 263-10)rdm:paediatric-designation/paediatric-designation-plan/

if there is a “paediatric indication, the section “HAS THIS APPLICATION BEEN SUBJECT TO PIP COMPLIANCE VERIFICATION?:” must be answered with specific values

21-8 = “Paediatric indication” then XOR (263-11, 263-12) = TRUE

(21-8) change-concerns/type= “Paediatric indication” (263-11, 263-12) rdm:paediatric-designation/pip-verification rdm:legislation:leg-type= “Regulation” rdm:legislation:leg-applies=”Yes" rdm:legislation /legislation-eu-code=”1768/92” rdm:legislation /leg-article/leg-article-number=”23.2.a” rdm:legislation /leg-article:leg-applies=”Yes” | ”No"



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rdm:paediatric-designation

eu-application-form


type2-variation-pediatric

rdm:legislation

pip-verification

rdm:legislation rdm:paediatric-designation rdm:attachment



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2.6.4 Type II Variations – Extended Data/Market Exclusivity Element Mapping Table Common DES 3.0 Context Common RDM Entry point variation-application-form/type2-variation-market-exclusivity/ Application

Field Id




264-1 Article 10(1) of Directive 2001/83/EC / Article 14(11) of Regulation (EC) No 726/2004


Var Data Exclusivity CTL Value=”Directive” Value=”Yes” Value=”2001/83/EC” Value= “10.1” Value=”Yes””

264-2 Article 10(5) of Directive 2001/83/EC rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Var Data Exclusivity CTL Value=”Directive” Value=”Yes” Value=”2001/83/EC” Value= “10.5” Value=”Yes””

264-3 Article 74(a) of Directive 2001/83/EC rdm:legislation:leg-type rdm:legislation:leg-applies rdm:legislation /legislation-eu-code rdm:legislation /leg-article/leg-article-number rdm:legislation /leg-article:leg-applies

Var Data Exclusivity CTL Value=”Directive” Value=”Yes” Value=”2001/83/EC” Value= “74.a” Value=”Yes””

Business rules table Rule fields id Source Context Target context Only one article may be selected for section “Type II variations - Extended data/market exclusivity” with specific values

XOR(264-1 to 264-3) = TRUE - (264-1 to 264-3 ) /... rdm:legislation:leg-type=”Directive” rdm:legislation:leg-applies=”Yes” rdm:legislation /legislation-eu-code=”2001/83/EC” rdm:legislation /leg-article/leg-article-number“10.1” | “10.5” | “74.a” rdm:legislation /leg-article:leg-applies=”Yes”



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rdm:legislation

eu-application-form


type2-variation-market-exclusivity



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2.6.5 Annexes: Product information proposals Element Mapping Table Common DES 3.0 Context Common RDM Entry point variation-application-form/-product information-proposals/ Application

Field Id




265-1 Summary of Product Characteristics rdm:attachment/short-name App Information Proposal CTL > term id Value=”Summary of Product Characteristics” 265-2 Manufacturing Authorisation Holder responsible

for batch release and conditions of the marketing Authorisation15

rdm:attachment/short-name App Information Proposal CTL > term id Value=”Manufacturing Authorisation Holder”

265-3 Labelling rdm:attachment/short-name App Information Proposal CTL > term id Value=”Labelling” 265-4 Package leaflet rdm:attachment/short-name App Information Proposal CTL > term id Value=”Package leaflet” 265-5 Mock-ups rdm:attachment/short-name App Information Proposal CTL > term id Value=”Mock-ups” 265-6 Specimens rdm:attachment/short-name App Information Proposal CTL > term id Value=”Specimens” Business rules table Rule fields id Source Context Target context - - - -


rdm:attachment

eu-application-form


Product-information-proposals

*



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2.6.6 Declaration of the Applicant for Type II Element mapping table Common DES 3.0 Context Common RDM Entry point variation-application-form/ Application

Field Id




266-1 Declaration of the applicant - 266-2 There are no other changes than those identified in

this application declaration/declaration-items/short-name App Information Proposal CTL > term id Value=”There are no other changes than those identified in

this application” 266-2 Where applicable, all conditions as set for the

variation(s)concerned are fulfilled declaration/declaration-items/short-name App Information Proposal CTL > term id Value=”Where applicable, all conditions as set for the

variation(s)concerned are fulfilled” 266-2 For type 1A notifications, the required documents as

specified for the changes concerned have been submitted

declaration/declaration-items/short-name App Information Proposal CTL > term id Value=”For type 1A notifications, the required documents as specified for the changes concerned have been submitted”

266-2 Where applicable, national fees have been paid declaration/declaration-items/short-name App Information Proposal CTL > term id Value=”Where applicable, national fees have been paid” 266-2 This application has been submitted simultaneously in

RMS and all CMSs declaration/declaration-items/short-name App Information Proposal CTL > term id Value=”This application has been submitted

simultaneously in RMS and all CMSs” 266-2 for worksharing only the MAs concerned belong to the

same MAH declaration/declaration-items/short-name App Information Proposal CTL > term id Value=”for worksharing only the MAs concerned belong to

the same MAH” 266-3 Change(s) will be implemented from Next production

run/next printing ? change from next production

266-4 Change(s) will be implemented from Date declaration/change-date change from date Fees paid or will be paid, if applicable - - 266-5 Amount/Currency fee-amount Ignored 266-6 Please specify fee category under National rules fee-category Ignored 266-7 Signature place ignored Signature place Signature place is present in old version of Variation form 266-8 Main Signatory - 266-9 Date signatories/main-signatory/date signature date Format: yyyy-mm-dd 266-10 Print name signatories/main-signatory/role/...

personal-title family-name given-name

Role > Party > Person > Personal title family name given name

266-11 Status (Job title) signatories/main-signatory/role/job-title Role > Party > Person > job title



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266-12 For worksharing/grouping... signatories/rdm:attachment

Second Signatory -

266-13 Print name signatories/second-signatory/role/... personal-title family-name given-name

Role > Party > Person > Personal title family name given name

266-14 Status (Job title) signatories/second-signatory/role/job-title Role > Party > Person > job title 266-15 Date signatories/second-signatory/date signature date Format: yyyy-mm-dd

Business rules table Rule fields id Source Context Target context



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rdm:role

eu-application-form

?


declaration fee-amount fee-category signatories

main-signatory second-signatory

rdm:role date date

declaration-items change-date

? ? ?

/CTL

/text /text

/date /date

/date


02-004-00010 ELECTRONIC

APPLICATION FORM

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3. ABOUT THIS DOCUMENT

3.1. Document location The document is located in the following folder on EDMS: documentum\Docbases\EDMS\Projects\02-004-00010-AF Implementation\2 Elaboration phase\New eAF DES standards

3.2. Definitions, Acronyms, and Abbreviations Additional definitions, acronyms, and abbreviations are described in the

3.3. Referenced documents Doc ID Title Locator

DES 3.0 Document DES 3.0 Specification Http://…/DES30.doc

DES 3.0 XSD DES 3.0 XSD dictionary file http://.../dictionary.xsd

DES 3.0 ANNEX 2 XSD Form XSD for Marketing application for veterinary use http://.../annex2.xsd.

3.4. Document Approval Date Submitted by Approved by Approver Role

21/6/2010 Philippe Deblire eAF Working Group Business Users

3.5. Document history Version Who Date What

00.00;01 Deblire Philippe 2009-03-11 [DRAFT] 00.01.01 Deblire Philippe 2009-03-16 [DRAFT] 00.01.02 Deblire Philippe 2009-03-16 Section 2 added 00.01.02 Deblire Philippe 2009-11-04 Updated in line with DES 2.0 1.2 Deblire Philippe 2010-04-15 Draft for reformed xsd 2.0 Deblire Philippe 2010-06-11 Draft DES 3.0 aligned

electronic application form data exchange standard 3esubmission.ema.europa.eu/eaf/docs/new...

Documents