Licensing
Evaluating medicinal products. Licensing health.
Tasks
The authorisation of finished medicinal products on the basis of the Medicinal Products Act ("Arzneimittelgesetz", AMG) is one of the main tasks of the BfArM. In the course of these licensing procedures, it reviews the health benefit, i.e. efficacy, safety, and pharmaceutical quality of the medicinal products. Furthermore, the BfArM fulfils important tasks in connection with drug licensing on a European level and thus makes a major contribution towards the prevention of risks to public health.
Forms
Renewals
-
Set of forms
concerning the application for renewal of a licence/registration according to Sections 31, 39 AMG - Table of contents (according to Common Technical Document - CTD)
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Cover letter
concerning the renewal application -
Annex 1
submission on pharmaceutical quality for licences according to Section 105 in connection with Section 109a AMG -
Annex 2
declaration on adaptation to BfArM core texts of package leaflet and SPC -
References
to the declaration concerning the pharmaceutical quality
Issues relevant for licensing
Announcements
- Announcement regarding the publication of the results of clinical trials in accordance with Section 42b of the Medicinal Products Act (Unofficial translation provided by the German Association of Research-based Pharmaceutical Companies, vfa)
- 3rd Announcement on Clinical Trials of Medicinal Products in Humans , Download_VeroeffentlichtAm_EN
- Announcement on the notification of variations for purely national licences in accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 which are within the BfArM's responsibility in accordance wtih Section 77 AMG