Notification obligations pursuant to Section 29 AMG and Sunset Clause Rule
Pursuant to Section 29 AMG (German Medicines Act), marketing authorisation holders have a number of notification obligations. These, among other things, serve to allow the authorities to have a certain amount of control of the so-called Sunset Clause rules.
In addition, a justification is required pursuant to Section 29 para 1g AMG for
Updated: 20.05.2021
The marketing authorisation holder must notify the competent higher federal authority immediately of the date on which the medicinal product is to be placed on the market, taking into consideration the different pharmaceutical forms and strengths authorised.
The marketing authorisation holder must notify the competent higher federal authority in compliance with sentence 2 in the event of temporary or permanent cessation of the marketing of the medicinal product. Notification must be submitted at least two months before the suspension of marketing. This does not apply in the event of circumstances over which the marketing authorisation holder has no control.
The holder of a marketing authorisation for medicinal products must notify the competent higher federal authority immediately of the reasons for temporarily or permanently ceasing to market or recalling the medicinal product, renouncing or failing to apply for the extension of the marketing authorisation. In particular, the marketing authorisation holder must explain whether the measure pursuant to sentence 1 is based on one of the grounds listed in section 25 (2) sentence 1 nos. 3, 4 or no. 5, section 30 (2) sentence 1 no. 1 or section 69 (1) sentence 2 no. 4 or no. 5. The notification pursuant to sentence 1 is also to be made if the measure is taken in a third country and is based on one of the grounds pursuant to sentence 2. If a measure pursuant to sentence 1 or sentence 3 is based on one of the reasons listed in sentence 2, the marketing authorisation holder must also notify the European Medicines Agency (EMA) thereof.
The marketing authorisation expires if the authorised medicinal product is not placed on the market within three years of the granting of the marketing authorisation, or if the authorised medicinal product that was placed on the market in accordance with the marketing authorisation is not placed on the market for three successive years.
Updated: 21.03.2024
Notification procedure regarding the sunset clause in accordance with section 29 subsections 1b and 1c of the Medicinal Products Act (Arzneimittelgesetz, AMG)
According to section 31 subsection 1 sentence 1 no. 1 of the AMG, known as the sunset clause rule, marketing authorisations expire if a pharmaceutical company does not make use of the marketing authorisation over a period of three years, i.e. does not place the medicinal product on the market. This means that the medicinal product was either not marketed within three years after the marketing authorisation was granted or that the authorised medicinal product was no longer marketed within three successive years.
Pharmaceutical companies are obliged to notify the senior federal authority when the marketing of a medicinal product begins as well as if there is a temporary suspension or permanent cessation of marketing a medicinal product (section 29 subsections 1b and 1c of the AMG). If the authority is notified of a cessation of placing on the market, this must be justified to the senior federal authority (section 29 subsection 1g of the AMG).
The AMG lays down that the competent senior federal authority can permit exceptions to the rule of section 31 subsection 1 sentence 1 no. 1 of the AMG if required for the protection of human or animal health (section 31 subsection 1 sentence 2 of the AMG). A suspension of this three-year period is also possible if no use can be made of the authorisation for legal reasons.
The notification procedure is only applicable for national authorisations that fall within the remit of the Paul-Ehrlich-Institut. Medicinal products authorised via the centralised procedure fall within the remit of the EMA. Therefore no additional notification has to be made to the Paul-Ehrlich-Institut regarding these products.
The sunset clause rule states that the marketing authorisation expires in Germany if the medicinal product has not been marketed in Germany for three successive years.
However, an application can be submitted for allowance of an exception in accordance with section 31 subsection 1 sentence 2 of the AMG, provided that the medicinal product is still marketed in at least one CMS. The application for allowance of an exception must be submitted in time before the marketing authorisation expires in accordance with section 31 subsection 1 sentence 1 no. 1 of the AMG.
Applications for exceptions to the Sunset Clause can be sent informally to eSubmission@pei.de.
Updated: 24.02.2025
Justification for ceasing to market pursuant to section 29 subsection 1g AMG
Pursuant to section 29 subsection 1g AMG, the holder of a marketing authorisation for medicinal products must notify the competent higher federal authority immediately of the grounds for:
In the notification, the marketing authorisation holder must explain if the measure taken is based on one of the following grounds:
The marketing authorisation holder is also obliged to inform the competent higher federal authority if the measure was taken in a third country or is based on one of the above reasons.
If one of the explicitly above stated grounds applies, marketing authorisation holders of medicinal products subject to Directive 2001/83/EC shall also notify the European Medicines Agency (EMA). Please note the information on the website of the EMA.
Updated: 06.06.2024
As of 1 March, 2024, notifications should be submitted digitally via the Sunset Clause portal on PharmNetBund.de pursuant to section 29 subsections 1b & 1c and section 141 subsection 7 of the Medicinal Products Act (Arzneimittelgesetz, AMG). The Sunset Clause notification procedure is described in detail on PharmNetBund.
In the past, notifications could be submitted using an informal letter. Now this process has been replaced by online notifications. The Paul-Ehrlich-Institut expressly requests that you refrain from submitting notifications in other formats (e.g. by letter or email) and only use the electronic procedure.
The Paul-Ehrlich-Institut helpdesk, which serves as the Single Point of Contact (SPoC), can answer any subject-specific or technical questions about Sunset Clause notifications. It processes the inquiries promptly in cooperation with the sections of the Paul-Ehrlich-Institut and, in the case of technical issues, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).
Please send your inquiries exclusively to:
Helpdesk for Sunset Clause questions
Email: AmAnDa-Kontakt@pei.de
Registration via the RuBen application is required to be able to use the Sunset Clause portal.
Marketing authorisation holders must re-register or expand their existing registration. After registering and logging in, users will reach the Sunset Clause portal interface, where they can submit notifications.
RuBen registration helpdesk
Phone: +49 221 4724 270
Email: helpdesk-technik@bfarm.de
Updated: 29.02.2024
