EMA: Updated Q&A documents on Centralised Procedures

Recommendation

28-30 March 2023

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In January 2021, the European Medicines Agency (EMA) published on its website updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised procedures. These Q&As are intended to provide guidance and support for marketing authorisation holders and applicants of centralised procedures and provide answers to potential questions before and during the submission.

Generics

For applicants of centralised procedures for generic or hybrid medicinal products, the explanations given in the Q&A paper "European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications" are of particular interest. The updated version includes an amendment to paragraph 2.1., which refers to the legal basis to be fulfilled.

Pre-authorisation advice

Questions related to issues before and during the submission of an application for a centralised procedure are listed and answered in the document "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure", which was last revised in October 2020. Amendments were made mainly to the subjects "paediatric use marketing authoristaion (PUMA)" (paragraph 1.7., paragraph 2.1.2.3. and paragraph 3.2.1.) and "dossier preparation, in particular proposed product name" (paragraph 3.1.1.).

Post-authorisation advice

The Q&A document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which was also updated in October 2020, was revised and published in its latest version on the EMA website as well. This questions and answers catalogue handles post-authorisation topics. It includes, for example, explanations on how to deal with variations or marketing authorisation renewals. The revised version mentions updates in paragraphs 3.8., 4.3., 14.2. and 16.11.

The new versions of the "Q&A" documents for centralised procedures can be found here:

• Generic and hybrid applications
• Pre-authorisation topics
• Post-authorisation topics