EMA – Review of the Question and Answer Documents for Centralized Procedure

On February 2021, the European Medicines Agency (EMA) published on its website an updated version of the document on post-authorisation procedural advice for users of the centralised procedure, which was last revised in January 2021.

This question-and-answer document is used as a guideline for marketing authorization holders and centralized procedure seekers, for relevant matters after the marketing authorization has been granted.

The latest version includes the following amendments and updates to chapters:

  • 1. Type IA variations (paragraphs 1.4., 1.6., 1.10., 1.11. AND 1.15.).

  • 2. Type IB variations (paragraphs 2.4., 2.11., 2.12 . And 2.14.).

  • Notifications (paragraphs 22.1., 22.3. AND 22.6.).

Another important Q&A document that was updated was on European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications. The most recent versions of these guidance documents can be found at:

  • Questions and Answers on procedural advice for users of the centralised procedure for generic/hybrid applications: https://bit.ly/3umz7tB

  • Questions and Answers on post-authorisation procedural advice for users of the centralised procedure: https://bit.ly/3spdSWl

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