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Variations

In accordance with Sections 22 - 24 AMG the competent federal higher authority has to be notified of changes in the information or documents without delay, accompanied by supporting documentation

Notification of these variations takes place either on the basis of the German Medicinal Products Act (AMG) or of Regulation (EC) No. 1234/2008, the so-called variation regulation.

As of 4 August 2013, the rules laid down in Chapter IIa of Commission Regulation (EC) No 1234/2008 of 24 November 2008 ("Variation Regulation") as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 must be applied for the submission and assessment of variations to the terms of purely national marketing authorisations.

The following medicinal products are exempted from this regulation:

  • Homeopathic marketing authorisations granted before 1 January 1998
  • Homeopathic medicinal products subject to Section 38 AMG
  • Traditional herbal medicinal products subject to Section 39 a - d AMG
  • Standard marketing authorisations subject to Section 36 AMG
  • Parallel imports

For variations to the terms of marketing authorisations for these medicinal products and variations not covered by Commission Regulation (EC) No 1234/2008, such as changes of the marketing authorisation holder or co-distributor, Section 29 of the German Medicines Act (AMG) remains applicable.

For further information regarding the processing of variations please refer to the CMDh Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure. (Homepage of the CMD(h))

Specific advice on purely national variations subject to the Variation Regulation which fall within the responsibility of the BfArM can be found in the BfArM announcement of 12 July 2013.