BfArM - Federal Institute for Drugs and Medical Devices

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Types of Marketing Authorisation

Before a medicinal product can be placed on the market it requires a marketing authorisation or registration. In order for these to be granted, the pharmaceutical entrepreneurs have to submit the corresponding applications to the BfArM. Depending on the nature of the project, different types of applications for marketing authorisation are available. The following pages provide information regarding the respective requirements.

Forms

Renewals

Variations

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

Biosimilars

Licensing of biosimilars

Due to rapid scientific progress, biotechnologically produced drugs are becoming increasingly important and naturally exhibit a certain batch-to-batch variability. The development and approval of biological drugs is therefore strictly regulated in order to guarantee consistent quality, safety and efficacy.

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Interchangeability of biosimilars

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have emphasised that biosimilars approved in the EU are interchangeable from a scientific viewpoint, meaning that a biosimilar can be used instead of its reference product, or vice versa. A biosimilar can likewise be used in place of another biosimilar of the same reference product.

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Bibliographical Application

It is possible to replace results of the pre-clinical and clinical trials by detailed references to published scientific literature if it can be demonstrated that the active substances of a medicinal product in the claimed therapeutic indication have been in well-established medicinal use within the Union for at least ten years, with recognised efficacy and an acceptable level of safety.

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Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)Complementary and Alternative Medicines

According to § 109a AMG, traditional medicinal products may also include medicinal products which do not belong to the so-called "particular therapeutic systems". They distinguish themselves from other medicinal products in that their efficacy is exclusively based on traditional use.

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