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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.

Information on transfer of the marketing authorisation holder

Changes to the marketing authorisation holder must be reported nationally in accordance with Section 29(1) of the German Medicinal Products Act (AMG). They are not covered by Commission Regulation (EC) No 1234/2008.

 The following documents must be submitted by the (previous or future) marketing authorisation holder:

• Cover letter clearly stating the change of marketing authorisation holder
• Application form

In order to ensure that notifications of changes are processed quickly, please submit notifications of changes via the PharmNet.Bund portal “electronic notifications of changes”. When using this application, please also note the general information on national notifications of changes.

• Valid extract from the commercial register for the new marketing authorisation holder if this is not already available to the higher federal authority
• Updated product information texts (editable Word files, version in revision mode and version with accepted changes)
• Declaration signed by the previous and future marketing authorisation holder regarding the change of marketing authorisation holder
• Declaration regarding the date of the change of marketing authorisation holder
  Note: If this declaration is not provided, the date of receipt of the notification of change by the Federal Supervisory Authority will be used as the basis.
• Authorisation letter from the marketing authorisation holder if the notification is submitted by another company (consultant) on behalf of the marketing authorisation holder
• Declaration of any changes to the contact details of the Qualified Person for Pharmacovigilance (QPPV) and the location of the Pharmacovigilance System Master File (PSMF)

Note: The new marketing authorisation holder is responsible for checking whether the change of marketing authorisation holder results in a new Pharmacovigilance System Master File (PSMF) and Summary of the Pharmacovigilance System (sPSMF). If this is the case, the new marketing authorisation holder must also submit a Type IAIN variation in accordance with Category C.I.8 of the Classification Guideline (2013/C 223/01).