electronic Application Form Data Exchange Standard 3.0

Transcription

1 ELECTRONIC APPLICATION FORM electronic Application Form Data Exchange Standard 3.0 Supplementary Specification Annex 3 Application for Renewal of Marketing Authorisation (Merged Version) 7.6, CURRENT 1

2 TABLE OF CONTENTS 1. Introduction How to read this document Sections Components The Elements Mapping Table The Business Rules Table The Element Tree Diagram (ETD) Renewal Application Form Application information Product Information Summary MAH Information Summary Declaration Maa Particulars Manufacturers Qualitative & Quantitative Composition Present & Proposed Changes Annexed Documents for Human and Veterinary application About this Document Definitions, Acronyms, and Abbreviations Acronyms Referenced documents Document Approval Document history

3 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. 3

4 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 The Elements Mapping Table This table describes how the mapping between the paper forms 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: Label: The label of the field in the application form is 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 <mappedto 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 : The RDM 3.0 may contain more or less elements because the RDM 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 in RDM model. 4

5 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 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 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. 5

6 2. RENEWAL APPLICATION FORM The Renewal 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 2.0 supplementary specifications for more info about those concepts). The remaining elements in the specific application form are kept in the DES 1.0 structure to facilitate the reading of the model. maa:eu_application_form/ Application > Elem Id Label DES 2.0 Mapping RDM 3.0 Mapping Remarks 2-1 HUMAN maa:renewal-form/maa:domain Domain CTL > term id Value= human use 2-2 VETERINARY maa:renewal-form/maa:domain Domain CTL > term id Value= veterinary use 2-3 APPLICATION FOR RENEWAL OF A MARKETING AUTHORISATION Page 1 Box 1 and Box 3 (application information) See section Page 1 Box 2 Column1 (Product and MAH information See section 2.2 and 2.3 summary) Last page, Last box (declaration) See section 2.4 Approved manufacturers See section 2.5 Box for PRESENT / PROPOSED product information text See section 2.6 DOCUMENTS APPENDED TO THIS APPLICATION See section 2.7 maa:envelope:formname Not mapped Value= APPLICATION FOR RENEWAL OF A MARKETING AUTHORISATION 6

7 2.1. Application information Concerning the ingredient, the mapping and associated value refer to a default situation. Many ingredients are measured with fractions and/or ranges with corresponding units: Ex: 5ug/10ml to 7ug/10ml maa:eu_application_form/maa:renewal-form/ Application > Layout: first box of the first page 21-1 NATIONAL AUTHORISATION IN MRP rdm:mp-procedure/procedure-type/short-name mp-procedure > Procedure Type CTL > term id Value= National Authorisation in MRP MRP procedure number rdm:mp-procedure/procedure-number mp-procedure > procedure number Value = Mutual recognition COMMUNITY AUTHORISATION rdm:mp-procedure/procedure-type/short-name mp-procedure > Procedure Type CTL > term id Value= Community authorisation NATIONAL AUTHORISATION ONLY rdm:mp-procedure/procedure-type/short-name mp-procedure > Procedure Type CTL > term id Value= National authorisation only 21-2 Reference Member state rdm:mp-procedure/country/short-name rdm:mp-procedure/country/term-id 21-3 Concerned Member states rdm:mp-procedure/rdm:mp-authorisation/country/short-name rdm:mp-procedure/rdm:mp-authorisation/country/term-id 21-4 Is the product currently marketed : Yes Not mapped mp-procedure > role > country CTL > term id Not mapped procedure use > role > country CTL > term id rdm:mp-authorisation:is-marketed Product Marketing > is product marketed Value= Yes No rdm:mp-authorisation:is-marketed Product Marketing > is product marketed Value= No 21-5 If yes, in which member states rdm:mp-authorisation/country/term-id Not mapped 21-6 Layout: Box with dates down page Date of first authorisation in Reference Member State/Community rdm:mp-authorisation/rdm:authorisation-date mp-procedure > rms first auth date 21-8 Date of expiry of current authorisation in Reference Member State/Community 21-9 Date of first authorisation in the Concerned Member State to which this application is made rdm:mp-authorisation/rdm:expiry-date mp-procedure > rms current auth expiry date rdm:mp-procedure/rdm:procedure-start-date mp-procedure > cms first auth date Date of expiry of current authorisation in the Concerned Member State rdm:mp-procedure/rdm:expiry-date mp-procedure > cms current auth expiry date Proposed Common Renewal Date: rdm:mp-procedure/rdm:proposed-date mp-procedure >Procedure Use > proposed common renewal date 7

8 Element Tree Diagram maa:eu_application-form maa:renewal-form maa:domain :CTL rdm:mp-authorisation rdm:mp-procedure 8

9 2.2. Product Information Summary Layout: Second Box of the first page maa:eu_application_form/maa:renewal-form/ Application > Medicinal product > 22-1 (Invented)Name: maa:invented-name Medicinal Product Group > invented name 22-2 Active substance(s): rdm:pharmaceutical-product/rdm:ingredient/rdm:substance/rdm:term-id rdm:pharmaceutical-product/rdm:ingredient/rdm:ingredient-role 22-3 Pharmacotherapeutic classification (Group + ATC code): rdm:atc-class Not mapped Pharmaceutical Product > Ingredient > Substance CTL > term id Pharmaceutical Product > Ingredient > Ingredient Role CTL > term id 22-4 (Group + rdm:atc-class/rdm:atc-name Not mapped 22-5 ATC code) rdm:atc-class/rdm:atc-code/rdm:short-name ATC Code CTL > term id 22-6 Pharmaceutical form(s) rdm:pharmaceutical-product/rdm:pharmaceutical-dose-form/rdm:term-id Pharmaceutical Product/pharmaceutical Dose Form CTL > term id Value= Active substance 22-7 and strength(s) rdm:pharmaceutical-product/rdm:ingredient/rdm:low-strength-numerator rdm:pharmaceutical-product/rdm:ingredient/rdm:low-strength-denominator rdm:pharmaceutical-product/rdm:ingredient/rdm:high-strength-numerator rdm:pharmaceutical-product/rdm:ingredient/rdm:high-strength-denominator rdm:pharmaceutical-product/rdm:ingredient/rdm:strength-numerator-unit/type rdm:pharmaceutical-product/rdm:ingredient/rdm:strength-denominator-unit/type rdm:pharmaceutical-product/rdm:ingredient/rdm:quantity-operator/type 22-8 Route(s) of administration 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 CTL > term id Pharmaceutical Product > Ingredient > Unit CTL > term id rdm:pharmaceutical-product/ rdm:route-of-administration/rdm:term-id Pharmaceutical Product > Route of Administration CTL 22-9 Target species rdm:target-population/rdm:species/rdm:short-name Target Population Species CTL > term id MA numbers (s) rdm:mp-authorisation/rdm:authorisation-number MP Authorisation > authorisation number 9

10 Element Tree Diagram maa:eu_application_form maa:renewal-form Invented-name :CTL rdm:mp-authorisation rdm:pharmaceutical-product maa:atc-class rdm:target-populkation 10

11 2.3. MAH Information Summary Layout: Right Side of the Second box of page 1 maa:eu_application_form/maa:renewal-form/rdm:application-actor/rdm:actor/ Application > 23-1 Name and address of MA holder: rdm:marketing-authorisation-holder/rdm:role Role > Role CTL > term id Value= Marketing Authorisation Holder 23-2 rdm:marketing-authorisation-holder/rdm:role/rdm:party-type rdm:marketing-authorisation-holder/rdm:role/rdm:name rdm:marketing-authorisation-holder/rdm:role/rdm:contact-details/rdm:address rdm:marketing-authorisation-holder/rdm:role/rdm:contact-details/rdm:city rdm:marketing-authorisation-holder/rdm:role/rdm:contact-details/rdm:post-code rdm:marketing-authorisation-holder/rdm:role/rdm:contact-details/rdm:country/rdm:short-name rdm:marketing-authorisation-holder/rdm:role/rdm:contact-details/rdm:country/rdm:term-id 23-2 Name and address of Contact rdm:contact-after-authorisation/rdm:role rdm:contact-after-authorisation/rdm:role/given-name rdm:contact-after-authorisation/rdm:role/family-name rdm:contact-after-authorisation/rdm:role/rdm:contact-details/rdm:address rdm:contact-after-authorisation/rdm:role/rdm:contact-details/rdm:city rdm:contact-after-authorisation/rdm:role/rdm:contact-details/rdm:post-code rdm:contact-after-authorisation/rdm:role/rdm:contact-details/rdm:country/rdm:short-name rdm:contact-after-authorisation/rdm:role/rdm:contact-details/rdm:country/rdm:term-id Role > Party > Party Type CTL > term d Role > Party > Organisation >Name Role > Party > Contact Details > address line 1 (to address line 5) Role > Party > Contact Details > city Role > Party > Contact Details > post-code Not mapped Role > Party > Contact Details > Country CTL > term id Role > Role CTL > term id Role > Party > Person > given-name Role > Party > Person > family name Role > Party > Contact Details > address line 1 (to address line 5) Role > Party > Contact Details > city Role > Party > Contact Details > post-code Not mapped Role > Party > Contact Details > Country CTL > term id 23-3 Telephone number: rdm:contact-after-authorisation/rdm:ole/rdm:contact-details/rdm:phone Role > Party > Role > Party > 23-4 Fax number: rdm:contact-after-authorisation/rdm:role/rdm:contact-details/rdm:fax Role > Party > Role > Party > rdm:contact-after-authorisation/rdm:role/rdm:contact-details/rdm: Role > Party > Role > Party > 23-6 Applicant's reference Not mapped applicant reference Value= Organisation 11

12 Element Tree Diagram renewal-form rdm:mp-procedure rdm:application rdm:application-actor rdm:actor 12

13 2.4. Declaration maa:eu_application_form/maa:renewal-form/ Application > Declaration info Fees paid or will be paid, if applicable maa:payment/maa:payment-status/ ignored 24-2 Amount/Currency maa:payment/maa:amount maa:payment/maa:currency ignored 24-3 Main Signatory maa:role/maa:main-signatory/maa:dec-signature ignored 24-4 Date maa:role/maa:main-signatory/maa:date signature date 24-5 Print name maa:role/maa:main-signatory/rdm:role/rdm:personal-title maa:role/maa:main-signatory/rdm:role/rdm:family-name maa:role/maa:main-signatory/rdm:role/rdm:given-name maa:role/maa:main-signatory/rdm:role/rdm:party-type/rdm:short-name Role > Party > Person > Personal title Role > Party > Person > family name Role > Party > Person > given name 24-6 Status (Job title) maa:role/maa:main-signatory/rdm:role/rdm:job-title Role > Party > Person > job title 24-7 Second Signatory maa:role/maa:main-signatory/ rdm:dec-signature ignored 24-8 Print name maa:role/maa:second-signatory/rdm:role/rdm:personal-title maa:role/maa:second-signatory/rdm:role/rdm:family-name maa:role/maa:second-signatory/rdm:role/rdm:given-name maa:role/maa:second-signatory/rdm:role/rdm:party-type/rdm:short-name Role > Party > Person > Personal title Role > Party > Person > family name Role > Party > Person > given name Not mapped 24-9 Status (Job title) maa:role/maa:second-signatory/rdm:role/rdm:job-title Role > Party > Person > job title Date maa:role/maa:second-signatory/maa:date signature date Value= person Value= person 13

14 Element Tree Diagram maa:eu-application-form maa:renewal-form maa:invented-name :CTL maa:payment maa:role maa:main-signatory maa:second-signatory maa:date :Date maa:dec-signature rdmrole maa:date maa:dec-signature rdm:role /text :Date /text 14

15 2.5. Maa Particulars Manufacturers Element Tree Diagram maa:eu-application-form maa:renewal-form maa:role maa:manufacturer-batch-release maa:contact-blood-vaccine maa:manufacturer-pharmaceutical-product maa:manufacturer-active-substance maa:manufacturer-batch-testing-site rdm:role rdm:role rdm:role rdm:role rdm:role 15

16 Manufacturer batch release maa:eu_application_form/maa:renewal-form/maa:role/maa:manufacturer-batch-release Application > APPROVED MANUFACTURERS - - Authorised manufacturer(s) (or importer) - - responsible for batch release in the EEA Company Name rdm:role/rdm:name rdm:role/rdm:party-type/rdm:short-name Address:; Country:; Telephone:; Telefax:; rdm:role/rdm:contact-detail/rdm:address rdm:role/rdm:contact-detail/rdm:city rdm:role/rdm:contact-detail/rdm:post-code rdm:role/rdm:contact-detail/rdm:country/rdm:short-name rdm:role/rdm:contact-detail/rdm:country/rdm:term-id rdm:role/rdm:contact-detail/rdm:phone rdm:role/rdm:contact-detail/rdm:fax rdm:role/rdm:contact-detail/rdm: Organisation >Name Party Type CTL > term d Contact Details > address line 1 (to address line 5) Contact Details > city Contact Details > post-code Not mapped Contact Details > Country CTL > term id Value= Organisation 16

17 Contact for blood product and vaccine maa:eu_application_form/maa:renewal-form/maa:role/maa:contact-blood-vaccine Application > For blood products and vaccines: - - Company Name Address:; Country:; Telephone:; Telefax:; rdm:role/rdm:name rdm:role/rdm:party-type/ rdm:short-name rdm:role/rdm:contact-detail/rdm:address rdm:role/rdm:contact-detail/rdm:city rdm:role/rdm:contact-detail/rdm:post-code rdm:role/rdm:contact-detail/rdm:country/rdm:short-name rdm:role/rdm:contact-detail/rdm:country/rdm:term-id rdm:role/rdm:contact-detail/rdm:phone rdm:role/rdm:contact-detail/rdm:fax rdm:role/rdm:contact-detail/rdm: Organisation >Name Party Type CTL > term d Contact Details > address line 1 (to address line 5) Contact Details > city Contact Details > post-code Not mapped Contact Details > Country CTL > term id Value= Organisation 17

18 Contact for batch testing sites maa:eu_application_form/maa:renewal-form/maa:role/maa:contact-batch-testing-site Application > Role > Party > Site(s) in EEA or in countries where an MRA or other Community arrangements apply, where batch control/testing takes place, Company Name rdm:role/rdm:name rdm:role/rdm:party-type/ rdm:short-name Address:; Country:; Telephone:; Telefax:; rdm:role/rdm:contact-detail/rdm:address rdm:role/rdm:contact-detail/rdm:city rdm:role/rdm:contact-detail/rdm:post-code rdm:role/rdm:contact-detail/rdm:country/rdm:short-name rdm:role/rdm:contact-detail/rdm:country/rdm:term-id rdm:role/rdm:contact-detail/rdm:phone rdm:role/rdm:contact-detail/rdm:fax rdm:role/rdm:contact-detail/rdm: Organisation >Name Party Type CTL > term d Contact Details > address line 1 (to address line 5) Contact Details > city Contact Details > post-code Not mapped Contact Details > Country CTL > term id 18

19 Manufacturer of medicinal product maa:eu_application_form/maa:renewal-form/maa:role/maa: manufacturer-pharmaceutical-product Application > Role > Party > Manufacturer(s) of the medicinal product and site(s) of manufacture (including diluent and solvent manufacturing sites): Company Name rdm:role/rdm:name rdm:role/rdm:party-type/ rdm:short-name Address:; Country:; Telephone:; Telefax:; Brief description of functions performed by manufacturer of dosage form/assembler, etc rdm:role/rdm:contact-detail/rdm:address rdm:role/rdm:contact-detail/rdm:city rdm:role/rdm:contact-detail/rdm:post-code rdm:role/rdm:contact-detail/rdm:country/rdm:short-name rdm:role/rdm:contact-detail/rdm:country/rdm:term-id rdm:role/rdm:contact-detail/rdm:phone rdm:role/rdm:contact-detail/rdm:fax rdm:role/rdm:contact-detail/rdm: actor-activities Organisation >Name Party Type CTL > term d Contact Details > address line 1 (to address line 5) Contact Details > city Contact Details > post-code Not mapped Contact Details > Country CTL > term id 19

20 Manufacturer of active substance maa:eu_application_form/maa:renewal-form/maa:role/maa:manufacturer-active-substance Application > Role > Party > Manufacturer(s) of the active substance(s) Company Name rdm:role/rdm:name rdm:role/rdm:party-type/ rdm:short-name Address:; Country:; Telephone:; Telefax:; - rdm:role/rdm:contact-detail/rdm:address rdm:role/rdm:contact-detail/rdm:city rdm:role/rdm:contact-detail/rdm:post-code rdm:role/rdm:contact-detail/rdm:country/rdm:short-name rdm:role/rdm:contact-detail/rdm:country/rdm:term-id rdm:role/rdm:contact-detail/rdm:phone rdm:role/rdm:contact-detail/rdm:fax rdm:role/rdm:contact-detail/rdm: Organisation >Name Party Type CTL > term d Contact Details > address line 1 (to address line 5) Contact Details > city Contact Details > post-code Not mapped Contact Details > Country CTL > term id 20

21 2.5.2 Qualitative & Quantitative Composition Active substances composition maa:eu_application_form/maa:renewal-form/maa:as-composition/rdm:pharmaceutical-product Application > Medicinal product > Pharmaceutical Product > QUALITATIVE AND - QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE SUBSTANCE(S) AND THE EXCIPIENT(S) Name of active substance*(s) /rdm:ingredient/rdm:substance/rdm:term-id Not mapped Ingredient > Substance CTL > term id Ingredient > Ingredient Role CTL > term id (1) (1) correpspnds to value= active substance Quantity rdm:ingredient/rdm:low-strength-numerator rdm:ingredient/rdm:low-strength-denominator rdm:ingredient/rdm:high-strength-numerator rdm:ingredient/rdm:ingredient/high-strength-denominator rdm:ingredient/rdm:quantity-operator/type Ingredient > low strength numerator Ingredient > low strength denominator Ingredient > high strength numerator Ingredient > high strength denominator Ingredient > Quantity Operator CTL > term id Unit rdm:ingredient/rdm:strength-numerator-unit/type rdm:ingredient/rdm:strength-denominator-unit/type Ingredient > Unit CTL > term id Ingredient > Unit CTL > term id Monograph standard rdm:ingredient/rdm:reference-monograph-standard Ignored 21

22 Excipients substance composition maa:eu_application_form/maa:renewal-form/maa:ex-composition/rdm:pharmaceutical-product Application > Medicinal product > Pharmaceutical Product > Name of excipient*(s) /rdm:ingredient/rdm:substance/rdm:term-id Ingredient > Substance CTL > term id (1) correpspnds to Not mapped Ingredient > Ingredient Role CTL > term id (1) value= excipient Quantity rdm:ingredient/rdm:low-strength-numerator rdm:ingredient/rdm:low-strength-denominator rdm:ingredient/rdm:high-strength-numerator rdm:ingredient/rdm:ingredient/high-strength-denominator rdm:ingredient/rdm:quantity-operator/type Ingredient > low strength numerator Ingredient > low strength denominator Ingredient > high strength numerator Ingredient > high strength denominator Ingredient > Quantity Operator CTL > term id Unit rdm:ingredient/rdm:strength-numerator-unit/type rdm:ingredient/rdm:strength-denominator-unit/type Ingredient > Unit CTL > term id Ingredient > Unit CTL > term id Monograph standard rdm:ingredient/rdm:reference-monograph-standard Ignored Overages maa:eu_application_form/maa:renewal-form/rdm:overage Application > Medicinal product > Pharmaceutical Product > Ingredient Details of any overages should not be included in the formulation but stated below active substances rdm:active-substance/rdm:shortname rdm:active-substance/rdm:term-id exipient rdm:excipient/rdm:short-name rdm:excipient/rdm:term-id active substance overage excipient overage 22

23 2.6. Present & Proposed Changes maa:eu_application_form/maa:renewal-form/maa:product-information Application > Application Proposal 26-1 PRESENT PRODUCT INFORMATION TEXT 26-2 PROPOSED PRODUCT INFORMATION TEXT maa:present-product-information present product info maa:proposed-product-information proposed product info 23

24 2.7. Annexed Documents for Human and Veterinary application Element mapping table The table For Human Medicinal Product Only and For Veterinary Medicinal Product Only are grouped in this table as they can be differentiated by the domain plus their attachment/term-id maa:eu_application_form/maa:renewal-form/maa:annex/maa:human-annex/ - DOCUMENJT APPENDED TO THIS APPLICATION ignored Cover Letter maa:cover-letter:is-attached ignored H:1.0; V: Comprehensive table of content maa:table-of-content:is-attached ignored H:1.1; V Renewal Application Form with the following annexes: maa:following-annexes:is-attached ignored H: 1.2; V: Details on contact persons: maa:product-presentations:is-attached ignored H:1.2; V: Qualified person in the EEA for Pharmacovigilance maa:eea-for-pharmacovigilance:is-attached ignored H:1.2; V: Contact person in the EEA with overall responsibility for product defects and recall maa:eea-overall-responsibility:is-attached ignored H:1.2; V: Contact person for scientific service in the EEA in charge of information about the medicinal product maa:eea-charge-of-information:is-attached ignored H:1.2; V: List of EU Member States / Norway / Iceland where the product is on the market and indicating for each country which presentations are marketed and the launch date 27-9 Chronological list of all post-authorisation submissions since grant of the Marketing authorisation or last renewal: a list of all approved or pending Type IA/IB and Type II variations, Extensions, Art 61(3) Notifications, USR, giving the procedure number (where applicable), date of submission, date of approval (if approved) and brief description of the change maa:eu-member-states:is-attached ignored H: 1.2; V: 2.3 maa:post-authorisation-submissions:is-attached ignored H: 1.2; V: Chronological list of Follow-up measures, and for Community Authorisations only, any Specific Obligations submitted maa:post-authorisation-submissions:is-attached ignored H: 1.2 since grant of marketing authorisation or last renewal indicating scope, status, date of submission and date when issue has been resolved (where applicable) Revised list of all remaining Follow-up measures/post-authorisation commitments, and for Community Authorisations maa:post-authorisation-commitments:is-attached ignored H: 1.2; V: 2.5 only any Specific Obligations and signed letter of commitment (where applicable) Proof of payment of fee, where relevant ignored V: A statement, or when available, a certificate of GMP compliance, not more than three years old, for the maa:certificate-of-gmp-compliance:is-attached ignored H:1.2; V:2.7 manufacturer(s) of the medicinal product listed in the application issued by an EEA competent authority or MRA partner authority. A reference to the Community EudraGMP database will suffice, once this is available For manufacturing sites of the medicinal product not located in the EEA or in the territory of an MRA partner, a list of maa:most-recent-gmp:is-attached ignored H:1.2; V 2.8 the most recent GMP inspections carried out by other authorities indicating the date, inspection team and outcome A declaration by the Qualified Person (QP) of each of the manufacturing authorization holders (i.e. located in the EEA) listed in the application form where the active substance(s) is used as a starting material, that the active substance(s) is manufactured in accordance with the guidelines on good manufacturing practice for starting materials as adopted by maa:qualified-person:is-attached ignored H: 1.2; V2.9 24

25 the Community Where different, a declaration by the Qualified Person (QP) of the manufacturing authorisation holder(s) listed in the application form as responsible for batch release, that the active substance(s) is manufactured in accordance with the guidelines on good manufacturing practice for starting materials as adopted by the Community5 maa:starting-materials:is-attached ignored H:1.2; V: SPC, Labelling and Package Leaflet maa:labelling-package:is-attached ignored H:1.3.1; V: Specimen (for Community Authorisations only) maa:specimen:is-attached ignored H: Information about the expert maa:expert-information:is-attached ignored H: Quality (incl. Signature + CV) maa:quality:is-attached ignored H: Non-clinical (incl. Signature + CV) if applicable (for Community Authorisations only) maa:non-clinical:is-attached ignored H: Clinical (incl. Signature + CV) maa:clinical-overview:is-attached ignored H: Quality Overall Summary (Quality Expert Statement) maa:quality-expert-statemen:is-attached ignored H Currently authorised specifications for the active substance and the finished product maa:authorised-specifications-active-substance:is-attached ignored V: Qualitative and quantitative composition in terms of the active substance(s) and the excipient(s) maa:composition:is-attached ignored V: Non-clinical Overview (Non-clinical Expert Statement) if applicable (for Community Authorisations only) maa:clinical-expert-statement:is-attached ignored H Clinical Overview (Clinical Expert Statement) maa:safety-expert-statement:is-attached ignored V:5; H: Reports of Post-marketing experience (Periodic Safety Update Report and Summary Bridging Report if applicable) maa:periodic-safety-update:is-attached ignored H: Safety expert statement maa:safety-expert-statement:is-attached ignored V: Periodic Safety Update Report and Summary Bridging Report if applicable maa:periodic-safety-update:is-attached ignored V: Declaration of current TSE status maa:tse-status:is-attached ignored V:8 25

26 ELECTRONIC APPLICATION FORM 3. ABOUT THIS DOCUMENT 3.1. Definitions, Acronyms, and Abbreviations Acronyms Name Definition cms concerned member state DCP DeCentralised Procedure DTD Data Type Definition ETD Element Tree Diagem EU European Community MA Marketing Authorisation MRP Mutual Recognition Procedure NP National Procedure RDM Reference Data Model rms Reference member state TSE Transmissible Spongiform Encephalopathy XML extended Markup Language XSL XML Stylesheet Language 3.2. Referenced documents Doc ID Title Locator DES 3.0 Document DES 3.0 Specification Data Exchange Standards (DES) - v3.0 (Draft) DES 3.0 XSD DES 3.0 ANNEX 3 XSD DES 3.0 XSD dictionary file Form XSD for Marketing application for veterinary use Renewal - Human and Vet - XML Schema Definition (Draft) Renewal - Human and Vet - XML Schema Definition (Draft) 3.3. Document Approval Date Submitted by Approved by Approver Role N/A 3.4. Document history Version Who Date What 00.00;01 Deblire Philippe Half of DTD Deblire Philippe Rest of DTD Deblire Philippe Add Discussion Board Deblire Philippe Update in line with DES Deblire Philippe Update in line with RDM 2.0 and revised XSD 26