EMA: Updates of the Q&A Documents for "Centralised Procedures"

In December 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised marketing authorization procedures on their website. These Q&A catalogs are intended to provide assistance and guidance to marketing authorization holders and centralised procedure applicants, and provide answers to potential questions at various stages of the centralised marketing authorization application process.

Questions related to issues prior to and during the submission of a centralised procedure are listed and answered in the revised document "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure". The latest version (as of December 2021) again draws attention to the fact that from January 2022 Irish will be used as authentic language in communication between the Agency and Irish applicants, thus ending the transitional period for this. A so-called "language waiver" must now be applied for, if the product information of the corresponding Irish marekting authorisation and the communication are to continue respectively to be available in English.

Updates and general changes have been made in the following passages as a result:

  • Paragraph 1.3. 
  • Paragraph 1.3.2. 
  • Paragraph 1.3.3. 
  • Paragraph 3.1.1. 
  • Paragraph 5.1.1. 
  • Paragraph 5.1.3.

Further information regarding the Irish language derogation ending on the 1st of January 2022 can be found on the EMA website.

Also, the Q&A document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" was amended in December 2021 to include the addendum regarding the ending of the Irish language derogation. The latest version is published on the EMA website. This Q&A catalog is dedicated to topics that may be relevant after the granting of marketing authorisation. These include, for example, explanations on how to deal with variation procedures or marketing authorization renewals.

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

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