Variations: How to submit Results of Confirmatory Stability Studies

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23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

As a part of the Heads of Medicines Agencies, the CMD(h) (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) is publishing a number of interesting documents. Best Practice Guides questions-and-answer documents give valuable information regarding the point of view of the European registration and supervisory authorities. Now, the Q/A-List for the Submission of Variations has been updated.

Question 2.13 is dealing with the submission of the results of confirmatory stability studies on production-scale batches where stability data for pilot-scale batches have already been accepted during application for a MA.

The answer is:
It is not generally foreseen that these data are submitted to NCAs, either via variation or simple notification. It is the responsibility of the applicant to perform these studies as agreed. However in cases where issues arise during the confirmatory studies with production-scale batches (e.g. unexpected impurities, trends towards out of specification results etc.), the MAH should either submit a variation, if appropriate, (e.g. to correct the shelf-life, storage conditions etc.) or contact the RMS who will then decide whether any corrective action has to be taken."

Here you can find the document with tracked changes.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The CMD(h) has started its activities in November 2005 and replaced the informal Mutual Recognition Facilitation Group, which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.