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Request for supergrouping

The PharmNet.Bund application ‘’Request for supergrouping number‘’ enables pharmaceutical companies to request the required supergrouping number ‘’DE/H/xxxx/IA/nnnn/G‘’ with BfArM as reference authority. Since supergroupings affect more than one marketing authorisation, the product number is no longer unique and must be replaced by ‘xxxx’. The procedure number with the associated sequence number (nnnn) cannot be formed by the marketing authorisation holder, but is automatically assigned upon request via the PharmNet.Bund application. If DE is not the RMS for all the marketing authorisations concerned, the BfArM can also be requested as the reference authority. Only the reference authority can assign the procedure number. When the applicant uses the application, the system asks for information on the supergrouping and uploads the letter of intent. The supergrouping number is then automatically communicated by the system.

When the supergrouping number is assigned, the system does not check whether the criteria for a supergrouping according to CMDh BPG Chapter 6 are met. In this context, please also note the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Marketing Authorisations (Joint announcement by BfArM and PEI).

On 17 September 2024, the previous application for a supergrouping number by email to ‘Variation-grouping-IA-number@bfarm.de’ at the BfArM was replaced by the new portal application. Since then, the BfArM no longer accepts applications by email.

This application does not affect worksharing procedures (in the case of type IB or type II variations). The current request by e-mail ( worksharing@bfarm.de ) remains in place here.

Supergrouping / Groupingnumber

Application for supergrouping or a grouping number

Request for Supergrouping / Groupingnumber

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