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
-
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)
-
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
Biosimilars
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