Your position:  Homepage » For Companies » Sunset Clause

content

Notifications for 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 must be made no less than two months before the interruption in supply or removal from the market.

Notifications in accordance with Section 29 sub-sections 1b and 1c AMG as well as with Section 141 sub-section 7 AMG

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).

Further information is available on the BfArM website.

Access and user authorisation

There is a role-based, central authentication and registration for the access to applications. The roles differentiate between the administrator in the higher federal authorities and the main user(representative) in a company or an authority. Other users are created and administrated by the representative.

In addition to customer data a X.509-certificate is needed for a first registration. This ensures sufficient safety for authentication and authorization.

More information about the certificate, request access authorization and user administration can be found in the user manuals below.

Supporting information

Last modified: 4/17/24

Your position:  Homepage » For Companies » Sunset Clause
© BfArM 2023

This website uses session cookies to ensure login to closed areas. In order to optimize the website, we use the analysis tool Matomo. Our Matomo installation works without tracking cookies. You will find more detailed information and the possibilities to object to the use of Matomo in our data privacy declaration.