New Guideline

Explanatory Note to GVP Module VII (March 2017)

This new explanatory note to GVP Module VII explains the purpose and requirements of key sections of the PSUR. The recommendations aim to reduce the number of issues and requests for clarification that are currently being raised with PRAC during the assessment period.

The explanatory note can be found here.

Updated Guidelines

EMA post-authorisation procedural advice (Rev.70, April 2017)

This Q&A has been updated with substantial new information relating to PV procedures.

NEW Q&A Periodic Safety Update Reports:

17.10. Do I have to submit a PSUR if the marketing authorization for my product has been granted on or after the data lock point (DLP) in the EURD list? NEW Mar 2017
17.11. My company holds a Parallel Import Authorisation; do we have to submit PSUR for these product(s)? If a PSUR is submitted will it be assessed? NEW Mar 2017
17.14. Do I have to submit a PSUR if my medicinal product is authorised in accordance with Article 126(a) of Directive 2001/83/EC? NEW Mar 2017
17.21. How to identify the official contact person for the PSUR? NEW Mar 2017
17.26. To whom should I submit follow-up data requested after the conclusion of a PSUSA procedure? NEW Mar 2017
17.28. How shall I implement the outcome of a PSUSA procedure? NEW Mar 2017

Revised Q&A Periodic Safety Update Reports:

17.2. What is the scope of PSUR assessment under the EU single assessment? Rev. Mar 2017
17.3. How shall I present my PSUR and in which format? Rev. Apr 2017
17.12. Do I have to submit a PSUR for my medicinal product if it is a generic, a product containing a well-established substance, a homeopathic or herbal medicinal product? Rev. Mar 2017
17.16. How can I submit the proposed changes to the product information within the PSUR for NAPs which are part of an EU single assessment? Rev. Mar 2017
17.17. Can I submit a RMP update together with my PSUR? Rev. Mar 2017
17.18. Can I submit a clinical study report together with my PSUR? Rev. Mar 2017
17.19. What are the timelines for the submission of PSURs? Rev. Mar 2017
17.20. To whom should I submit my PSUR? Rev. Mar 2017
17.22. What fee do I have to pay? Rev. Mar 2017
17.23. How will my PSUR submission be handled? Rev. Mar 2017
17.24. How shall I submit the response to a request for supplementary information during a PSUSA procedure? Rev. Mar 2017
17.25. How is the CHMP opinion/CMDh position structured and which annexes need to be translated? Rev. Mar 2017
17.27. How can I know about the outcome of a PSUSA procedure? Rev. Mar 2017
17.31. Who should I contact if I have a technical issue with the submission of the PSUR? Rev. Mar 2017


Revised Q&A: Post Authorisation Safety Study (PASS):

13.8. Who should I contact if I have a question when preparing my application and during the procedure? Rev. Feb 2017

The questions and answers document can be found here.


EUDRAC provide full pharmacovigilance services for clients in all EU Member States and supply PV Intelligence updates for all countries.

Please see more details at http://www.eudrac.com/services/pharmacovigilance/