Changes in the Pharmacopoeia: how to submit a Variation?

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) has published an updated version of its Q&As on Variations according to Commission Regulation (EC) 1234/2008. Currently 39 frequently asked questions are grouped into the following categories:

  • General questions
  • Questions relating to the submission of variations
  • Questions relating to the classification of a variation
  • Questions relating to grouping and worksharing
  • Questions regarding the approval and implementation of variations

In the latest revision, a question regarding pharmacopoeial updates was added:

Question 3.8
"When general monographs of the Ph.Eur. or product specific monographs of a national pharmacopoeia of a Member State are updated how should variations affecting the finished product be submitted?"


"Variation B.III.2 only relates to active substances, excipients and active substance starting material. Changes to comply with Ph.Eur. or with a national pharmacopoeia of a Member States affecting the finished product should be submitted according to the relevant variations listed under B.II.d. There is no need to notify the competent authorities of an updated monograph of the European pharmacopoeia or a national pharmacopoeia of a Member State in the case that compliance with the updated monograph is implemented within six months of its publication and reference is made to the 'current edition' in the dossier of an authorised medicinal product."

Other new Q&As were added under categories 'submission of variations' and 'grouping and worksharing'.

The document with tracked changes can be found here.

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.

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