Variations Regulation: how to classify special Changes

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) has updated their Q&As on Variations according to Commission Regulation (EC) 1234/2008.

A question was added on the classification of special changes:
"If the correct category for a special change is not listed in the classification guideline and the applicant is not sure about the correct variation type, is it possible to liaise with the RMS?"

"Generally it is the duty of the applicant to identify the correct variation type and to classify the variation procedures by themselves and to choose the correct variation type incl. the IB by default variation. Only in exceptional cases it is, however, necessary to contact the RMS, e.g. for grouping applications not listed in Annex III of the Regulation. Any advice received by the RMS has then to be submitted in writing as addendum to the application form together with the variation application."

Please also see the document with the 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.

Compiled by Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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