Sunset Clause
The Marketing Authorisation (MA) holder is required to notify the national competent authority (NCA) of the date of actual marketing of the medicinal product, taking account of the various presentations authorised, and to notify the NCA if the product ceases to be placed on the market either temporarily or permanently. Except in exceptional circumstances, the notification shall be made no later than two months before the cessation of the placing on the market.
The commencement of the Fourteenth Law amending the Medicinal Products Act of 29 August 2005 (Federal Law Gazette/ BGBl I p. 2570) on 6 September 2005 extended the notification requirements for medicinal products to include marketing and discontinuation of marketing by the holder of the marketing authorisation (Section 29 sub-sections 1b and 1c AMG). This also applies to medicinal products not being marketed at the time the 14th Amendment of the AMG came into force (Section 141 number 7 AMG).
Information on the electronic notification procedure (marketing and cessation of marketing)
For notifications in accordance with Section 29 sub-sections 1b and 1c AMG as well as with Section 141 sub-section 7 AMG an online procedure was developed which should be used for such reports.
The BfArM expressly requests use of this electronic procedure as opposed to conventional notifications.
The PharmNet.Bund application “Notifications for Sunset Clause”
Before using the procedure for the first time, it is strongly recommended to read and consider the information and documents available there. In addition to the "Short manual for Sunset Clause" the previous explanations are still available here.
Electronic application portal for exemptions and suspensions to the sunset clause
According to section 31 sub-section 1 sentence 1 no. 1 AMG, the marketing authorisation expires if the authorised medicinal product is not placed on the market within three years of the authorisation being granted or if the authorised medicinal product that was placed on the market after the authorisation was granted is no longer on the market for three consecutive years.
According to section 31 sub-section 1 sentence 2 AMG, the competent higher federal authority may allow exceptions if this is necessary for reasons of health protection. In addition, the 3-year period can be suspended if the authorisation cannot be used for legal reasons.
An electronic application portal for exemptions and suspensions to the sunset clause was developed which should be used for such applications. The BfArM expressly requests use of this electronic procedure as opposed to conventional applications.
The PharmNet.Bund application “Sunset Clause - Exceptions”
Further information
Joint announcement of the Federal Institute for Drugs and Medical Devices (BfArM) and the Federal Office of Consumer Protection and Food Safety (BVL) on the change in administrative practice regarding the expiry of marketing authorisations pursuant to Section 31 (1) sentence 1 no. 1 AMG (only available in German):
FAQ
Frequently asked questions in the topic area sunset clause
Contact for questions and problems
If, despite correct entry and taking the explanations into account, problems arise with the transmission of notifications or if you have questions about the ssunset clause application, please contact the e-mail address
sunset-clause@bfarm.de
.
For questions regarding registration or certificates please contact helpdesk-technik@bfarm.de