Medicinal products
Evaluating benefit. Minimising risks.
Tasks
Both marketing authorisation and registration of medicinal products belong to the main tasks of the BfArM. Medicinal products are substances that are used to treat diseases, to relieve complaints, or to prevent such diseases or complaints in the first place. This definition applies regardless of whether the medicinal product is administered to humans or to animals. The substances can act both within or on the body. The legal definition of medicinal products is laid down in Section 2 of the German Medicinal Products Act (Arzneimittelgesetz, AMG).
Forms
Licensing Forms - Renewals
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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
Pharmacovigilance Forms
- Reporting form for adverse drug reactions (ADR)
- Reporting form for communication of quality defects, batch recalls, and counterfeit drugs
- Form for submission of PSURs
- Form for submission of PSURs
- Form for prolongation of the PSUR submission interval
- Notification of a change to the Stufenplanbeauftragter
- Notification of the Stufenplanbeauftragter