EMA update pre- and post-authorisation procedural advice for centralised procedures

Below is a summary of the updated Q&A documents released by the European Medicines Agency (EMA) for users of the centralised procedure.

Pre-authorisation procedural advice

This guidance document addresses a number of questions which users of the centralised procedure may have. It provide an overview of issues which are typically addressed during the course of pre-submission meetings.

The update includes the following revised questions and answers:

  • 2. How can I tell if I am duly established in the EEA as an applicant?
  • 7. How should I notify a change in the intended submission date of my application?
  • 9. How is a marketing authorisation application pre-submission meeting conducted at EMA?
  • 2.4. What aspects should I consider at time of submission of my application for marketing authorisation if there are orphan medicinal products designated or authorised for a condition related to my proposed therapeutic indication?
  • What aspects should I consider if my medicinal product is considered similar to an orphan medicinal product?
  • 1. How and to whom should I submit my dossier?
  • 4. What fee do I have to pay?
  • 1.1. How long does it take for my application to be evaluated

Post-authorisation procedural advice

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of issues which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

The update includes the following revised questions and answers:

  • 4. How shall I present and submit my Type IA/ IAIN Variation(s)?
  • 8. What fee do I have to pay for a Type IA/ IAIN variation?
  • 15. Who should I contact if I have a question when preparing my application or during the procedure?
  • 4. How shall I present and submit my Type IB Variation?
  • 8. What fee do I have to pay for a Type IB Variation?
  • 14. Who should I contact if I have a question when preparing my application or during the procedure?
  • 7. How shall I present my type II Variation application?
  • 13. Which post-opinion steps apply to my type II variation and when can I implement the approved changes?
  • 14. What fee do I have to pay for a type II variation?
  • 20. What aspects should I consider at time of submission of a type II variation if there are orphan medicinal products designated or authorised for a condition related to my proposed therapeutic indication?
  • 5. How shall I present my Extension Application?
  • 6. What aspects should I consider at time of submission of an extension application if there are orphan medicinal products designated or authorised for a condition related to my proposed therapeutic indication?
  • 12. How shall my Extension Application be handled (timetable)?
  • 13. What fee do I have to pay for an Extension Application?
  • 3. How shall I present a grouped variations application?
  • 6. How will grouped variation applications be handled (timetable)? What will be the outcome of the evaluation of a grouped variation application?
  • 8. What fee do I have to pay for grouped variations?
  • 4. When can I expect to receive a response to my query?
  • 3. How shall I present my annual re-assessment application?
  • 2. When shall I submit my renewal application?
  • 3. How shall I present my renewal application?
  • 3. How shall I present my annual renewal application?
  • 4. How shall I present my non-interventional imposed PASS and in which format?
  • 5. To whom should I submit my imposed non-interventional PASS?
  • 6. How do I submit a joint PASS?
  • 5. What is a legally binding measure [‘LEG’]?
  • 9. Under which procedure should I submit my PAM?
  • 10. How shall I structure my PAM submission dossier?
  • 12. How long after the European Commission decision should Annex 1 of the RMP be submitted to EudraVigilance?
  • 13. How and to whom shall I submit my RMP application?
  • 3. How shall I present my PSUR and in which format?
  • 3. How shall I present my article 46 paediatric study application at submission?
  • 5. How to choose the implementation date?
  • 15. Who should I contact if I have a question when preparing my application or during the procedure?

The information in these updated documents, alongside effective pre-submission communication between the MAH and the EMA should enable efficient submission, review and validation of applications, whilst still being in conformity with the legal and regulatory requirements.