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EU: EMA Improves its Guidance for Post-Authorisation Activities

Friday, July 14, 2017: The European Medicines Agency (EMA) has updated its best practice guidelines and support documents for marketing authorisation holders (MAHs) in the areas of type II variations, post-authorisation safety studies and changes related to quality aspects.

The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes. This will result in a more efficient validation process. The guidance documents are part of EMA's commitment to operational excellence. The main updates are:

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