EMA updates Q&A Document on Procedures Issues for Holders of a Centralised Marketing Authorisation

The questions and answers document of the EMA entitled "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" deals with procedural issues which are typically addressed in discussions or meetings between the EMA and MAHs in the post-authorisation phase. This document is being regularly updated. The last update was performed in June 2013 and addressed the following topics:

  • Post-Authorisation Measures (PAMs)
    An authorisation may be granted even if the amount of data available at that time is not yet sufficient to prove the quality, safety or efficacy of a medicinal product. The MAH gets the authorisation upon condition that he continues to collect more data about the marketed product in the post-authorisation phase. The EMA classifies the PAMs in 5 categories:

    - Specific obligation (SOB)
    Such obligations can only be imposed to the MAH on marketing authorisations granted under exceptional circumstances or on conditional marketing authorisations. The completion of the data on quality, safety and efficacy is legally binding and directly coupled with the granting of the authorisation.

    - Annex 2 Conditions (ANX)
    The EMA may require additional information from the MAH at the time of the granting of the marketing authorisation or later - mainly data regarding the safety and efficacy of a medicinal product.

    - Additional Pharmacovigilance activity in the RMP (MEA)
    This measures package includes clinical studies which must be conducted by the MAH on the authorised medicinal product to remove any safety concerns.

    - Legally binding measures ("LEG")
    They concern data for periodic safety update reports (PSUR) as well as CAPA measures in the context of inspections.

    -Recommendation ("REC")
    The EMA may issue recommendations for further development of a medicinal product, i.e. with regard to some quality aspects or considerations for extending the patient population. These recommendations are not binding.

The topic of Post-Authorisation Measures has been newly added to the Questions and Answers collection.

  • Transfer of Marketing Authorisation
    The EMA has provided precise details about how an application for the transfer of a marketing authorisation should be presented. Basically, the CTD format should be used. The question of fees due for the transfer of a marketing authorisation has also been updated.
    In the event of this topic, another question and its respective answer have been added regarding changing the name of a medicinal product as part of a transfer application. In short, the answer is: Yes. But to change the name of a medicinal product, a variation is required which means that a separate application should be submitted.

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