Reports in Accordance with Section 29 Sub-sections 1b and 1c AMG as well as with Section 141 Sub-section 7 AMG Notification Procedure on the "Sunset Clause"
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 yet being marketed at the time the 14th Amendment of the AMG came into force (Section 141 number 7 AMG).
For notifications in accordance with Section 29 sub-sections 1b and 1c AMG as well as with Section 141 sub-section 7 AMG the BfArM has developed an online procedure which should be used for such reports. It is now possible to notify marketing and discontinuation of marketing on workdays between 8:00 am and 6:00 pm by way of an online form.
The BfArM expressly requests use of this electronic procedure as opposed to conventional notifications.
It is urgently recommended to read the "Erläuterungen des BfArM zur Sunset Clause" (PDF) prior to first use of this procedure. These explanatory notes describe the individual steps and entry masks in detail.