1. 1 Harmonisation of requirements: where we are Erik Waterdrinker, IFAH-Europe 2nd Veterinary Workshop on E-submission 4 Dec 2009, EMEA, London

2. 2 Harmonisation of requirements Agenda: 1 - Outline 2 - Impact of revised guideline 3 - Can the same electronic dossier be submitted in all countries ? 4 - Impact of national requirements –An industry perspective

3. 3 Harmonisation of requirements 1 - Outline

4. 4 Harmonisation of requirements: Outline E-submission remains optional for industry. –Since 2005, HMA target to implement infrastructure and processes to accept electronic submissions by the end of 2009 Clear benefits for both the Regulators and Industry –Less paper production –More efficient and practical evaluation environment –New approach to dossier maintenance and lifecycle management –Less archiving space

5. 5 Harmonisation of requirements: Outline Common specifications for electronic submission TIGes Vet Guideline on the specification for an e- submission, a single standard across the EU based on NTA (Notice to Applicants) Strong message to all stakeholders to harmonise the requirements for all e-submissions in Europe since first national specifications in 2004.

6. 6 Harmonisation of requirements 2 - Impact of revised guideline

7. 7 Harmonisation of requirements: Impact of revised guideline The major changes brought by the revised guideline (1): VNees Introduction to eNTA concept based on XML backbone technology. Media and File protections are not permitted Addition of specifications for the folder structure as per the NTA ( notice to applicants), volume 6B. GTOC and TOC with functional hyperlinks

8. 8 Harmonisation of requirements: Impact of revised guideline The major changes brought by the revised guideline (2): A detailed 3 layer only folder system to match all types of applications and dossier contents –How to adapt this folder system to applications concerning older dossiers ? –How to adapt this format when submitting different types of applications such as grouped applications as per the variation Regulation. A detailed folder and file naming convention

9. 9 Harmonisation of requirements: Impact of revised guideline The major changes brought by the revised guideline (3): Validation requirements and checks –Virus free –No types of security or protection on media of files –Folder structure and naming conventions –No files above 100 MB –Presence of GTOC and TOC with functional hyperlinks –All documents in PDF 1.4 The Industry may not have specific software (or different software) in place with regulators which may lead to validation problems.

10. 10 Harmonisation of requirements: Impact of revised guideline The major changes brought by the amended guideline (4): Software and Hardware –Confirmation that no specific software or hardware is required for the preparation of VNees applications –Bespoke software required for eNTA types of e- submission. Simple electronic renditions of paper applications can reduce the volume of paper. Can this situation persist after January 2010 ?

11. 11 Harmonisation of requirements 3 - Can the same electronic dossier be submitted in all countries ?

12. 12 Harmonisation of requirements: can the same electronic dossier be submitted in all countries ? How to ensure that the common electronic dossier in its form and contents is accepted throughout all Member States, under any procedure: NP MRP DCP CP. –How to manage local translations of parts of the dossier ? –How to manage national specifications ? National guidances on E-submission have already been published and may differ. Can Industry afford several specifications?

13. 13 Harmonisation of requirements: can the same electronic dossier be submitted in all countries ? The guideline will be applicable for the centralised procedure. –Amendment of the CVMP requirement sheet ? Will it be applicable for NP, MRP, DCP ? –Many Member States already accept electronic copies –Is Chapter 7 of Volume 6B to be amended ? –Are national specifications on e-submission to be amended ? Paper copies : are these relevant as dossiers structured according to VNees or eNTA are not convenient for printing on paper: –Absence of pagination

14. 14 Harmonisation of requirements 4 - Impact of national requirements

15. 15 Harmonisation of requirements: impact of national specifications List of issues that may represent a hurdle to a common electronic dossier: Translation of English documents such as expert reports. Original signatures may be required, for the application form or any signed document National TSE forms, not the NTA form National mock ups Certified copies of agreements between manufacturers and marketing authorisation holders. Certified copies of marketing authorisation documents.

16. 16 Harmonisation of requirements: impact of national specifications List of issues that may represent a hurdle to a common electronic dossier ( continued): Power of attorneys to name the persons allowed to sign the application Extracts from the local chamber of commerce with sworn translations and authentication by the local consulate. Proof of trade mark registration National application forms, either specific or translations of the EU form. Complex national fee structure: could be managed outside the scope of an individual application or paid upon invoice ?

17. 17 Harmonisation of requirements Conclusion

18. 18 Harmonisation of requirements: Conclusion Impact of revised guidance ? –A clear message to move forward and propose a harmonised environment for E-submission. Paper remains possible. E-submission is only optional. Can the same e-dossier be submitted in all countries ? –Not yet clear for Industry. For centralised procedures, yes. For MRP, DCP and NP, risk of facing validation problems and therefore delays. Impact of national requirements ? –Major point for industry to resolve in order to allow for a single dossier to be accepted throughout Europe.

19. 19 Harmonisation of requirements: Conclusion Industry welcomes any initiative, especially from the TIGes Vet group, to ensure the guideline is adopted in all Member States. E-submission should pave the way to a more efficient submission, validation and evaluation process for applications Thank you