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).

The application "Notifications for Sunset Clause" should be used for these notifications.

Sunset Clause - Applications for exemption and suspension

According to section 31 sub-section 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.

The application "Sunset Clause - Exceptions" should be used for these applications.

Further information is available on the BfArM website: Sunset Clause.