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Licensing Procedures

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The marketing authorisation procedure evaluates whether a medicinal product is efficacious and safe and whether it has the required pharmaceutical quality. The necessary documentation is submitted to the regulatory authorities by the pharmaceutical company that intends to place the medicinal product on the market.

The licensing documentation includes data on analytical, pharmacological-toxicological, and clinical trials as well as the corresponding expert reports. Furthermore, the pharmaceutical company has to present the Package Leaflet and Summary of Product Characteristics, labelling texts, and information on the pack sizes. An exact description of the intended pharmacovigilance and risk-management systems is also part of the licensing documentation.

The legal basis for granting a marketing authorisation in Germany is Section 21 (1) of the German Medicines Act ("Arzneimittelgesetz", AMG); where the content requirements for the marketing authorisation documentation are laid down in Sections 22 to 24.

Contact Persons

Contact persons for licensing

Contact persons for licensing

FAQ

What has to be considered when preparing national translations?

If the final English product information is based upon a CHMP referral or a centralised procedure, the corresponding German translation has to be used.

If parallel procedures are concluded with identical final English product information, identical German translations have to be submitted.

If considered necessary, BfArM may declare one translation binding.

What is the contact address for the submission of translations?

In what form should the national texts be submitted?

The national texts are to be inserted into the “Bescheidmaske”, which is made available on the BfArM homepage.

Submissions without a “Bescheidmaske” will be rejected unprocessed.

For each strength, a separate “Bescheidmaske” must be submitted in which the first pages (up to the signature) are completely filled in.

The text of the product information is only to be inserted in Annexes 1-3 of the “Bescheidmaske” for the lowest strength.

If a combined “Fachinformation” for several strengths is intended, sections 1, 2, 3, 4 (excipient warnings, if applicable) and 6 in Appendix 4 shall be completed for all strengths.

If the texts for different strengths of a medicinal product differ in terms of content (e.g. indication, dosage), a fully completed “Bescheidmaske” must be submitted for each strength.

In addition, the product information for all strengths / parallel processes must be submitted in Word format.

More FAQs on the topic

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Further information about DCP and MRP

National Licensing Procedures

If a medicinal product is to be marketed exclusively in Germany, a national approval process must be carried out.

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Centralised Licensing Procedures

A Marketing Authorisation (MA) for a medicinal product intended for the use in all EU/EEA countries may be obtained submitting an application to the European Medicines Agency (EMA) for those products falling within the scope of the centralised procedures (CP).

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