On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of the centralised procedure (“the guidance document”).

Background

The aim of this guidance document is to enable marketing authorisation holders (“MAHs”) to submit post-authorisation applications which are in conformity with applicable legal and regulatory requirements and which can be validated and processed promptly by the EMA. Post-authorisation applications include applications for extensions or variations of marketing authorisations.

For this purpose, the guidance document addresses a number of questions which MAHs may have on post-authorisation procedures. The guidance document provides an overview of the Agency’s position on issues which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

The guidance document is structured as a Questions & Answers (“Q&As”) paper that is being updated continuously to reflect new developments and the implementation of the new European legislation. The EMA also updates the Q&As to include guidance on further post-authorisation procedures.

The EMA highlights in the guidance document that the Q&As should be read in conjunction with The Rules governing Medicinal Products in the European Union, Volume 2, Notice to Applicants.

New or revised questions

The EMA published the guidance document with the new or revised questions and their corresponding answers marked as “NEW” or “Rev.” with the relevant date.

The new or revised questions dated 19 December 2016 include the following:

1. Type IA variations

1.1. When shall I submit my Type IA/IAIN variation(s)?

1.4. How shall I present and submit my Type IA/ IAIN Variation(s)?

3. Type II variations

3.1. What changes are considered Type II Variations?

3.2. Is the Co-Rapporteur involved in Type II Variations?

3.3. Is the PRAC Rapporteur involved in type II variations? – NEW

3.5. How shall I present my type II Variation application?

3.6. How shall I present my application for a new or modified therapeutic indication? – NEW

3.8. When shall I submit my type II variation?

3.9. How shall my Type II application be handled (timetable)?

3.10. How should parallel type II variations that affect the product information be handled? – NEW

3.11. Which post-opinion steps apply to my type II variation and when can I implement the approved changes?

3.14. When do I have to submit revised product information? In all languages?

3.15. What changes will trigger new EU number(s) (additional presentation(s))?

3.19. Do I need to confirm the maintenance of my orphan designation when applying for a type II variation?

3.23. When will I get a PIP compliance statement? – NEW

5. Grouping of variations

5.2. What groups of variations would be considered acceptable?

5.3. How shall I present a grouped variations application?

5.4. What procedure number will be given to grouped variation applications?

6. Worksharing of variations

6.4. How shall I present a variation application under worksharing?

6.6. What procedure number will be given to variation applications under worksharing?

For further information visit: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf