EMA: Update Q&A "Centralised Procedures"

In late June 2023, the European Medicines Agency updated two Q&A documents on centralised marketing authorization procedures. With this, EMA provides scientific and regulatory advice to pharmaceutical companies on the regulatory process for the European drug approval. Q&As relevant before, during, and after the approval of medicines for the European market have been updated or newly added.

A brief summary:

The update to the Q&A "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" includes:

• Question 3.5.15. When should I submit the RMP Annex 1 to EudraVigilance? (Rev. June 2023)
• Question 5.1.10. How and when can I withdraw my application? (Rev. June 2023)

The Q&A "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure“ comes with two revised and two new questions:

• Question 3.26. How and when can I withdraw my Type II variation application? (NEW Jun 2023)
• Question 4.5. How shall I present my Extension Application? (Rev. Apr 2023)
• Question 4.20. How and when can I withdraw my Extension Application? (NEW Jun 2023)
• Question 16.11. How long after the European Commission decision should Annex 1 of the RMP be submitted to EudraVigilance? (Rev. Jun 2023)

The Agency's Q&A documents are regularly updated to reflect updated European legislation. The questions and answers are marked with the amendment date.

Source:

EMA: Post-authorisation, Pre-authorisation