Tasks

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 medicinal products for administration to human beings that are subject to approval, and which were approved before 1 January 1998 or which are classified as being approved.
• homeopathic registrations according to Section 38 AMG
• registered traditional herbal medicinal products according to Sections 39 a-d AMG
• blood components referred to in Article 3(6) of Directive 2001/83/EC
• tissue preparations authorised pursuant to Section 21 AMG, unless an industrial process is used in their manufacture
• parallel imports
• standardised licences according to Section 36 AMG

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.

Specific advice on purely national variations subject to the Variation Regulation which fall within the responsibility of the BfArM can be found in the Joint Announcement by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines (PEI) on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 dated 16 April 2025.