top of page

EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure

Yesterday (13 October 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure".

The EMA's guidance on post-authorisation procedural advice serves as a resource for pharmaceutical companies and stakeholders involved in the post-approval phase of the centralised procedure, which is applicable to certain types of innovative medicines and therapies. It underlines the importance of ensuring the continued safety, efficacy, and compliance of medicines in the EU, post-approval.

The guidance outlines the various post-authorisation procedures and their respective timelines. It covers variations, renewals, line extensions, and other processes that are necessary after medicine has received marketing authorisation.

The updates were on the below questions

  • Is the Co-Rapporteur involved in Type II Variations?

  • Under which procedure should I submit my non-interventional imposed PASS?

  • When should I register my studies in the EU PAS Register?

  • When and how will the RMP Summary be published on the EMA website?

  • What is the “Article 46 paediatric study submission”

  • How should I request the withdrawal of my central marketing authorisation?

Click this LINK to know more in detail about the number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures.


bottom of page