Notifications § 29 AMG (Sunset Clause)
Notifications § 29 AMG (Sunset Clause)
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
- the temporary or final cessation of placing on the market of a medicinal product,
- the recall of a medicinal product,
- the renunciation of a marketing authorisation, and
- the non-application for a renewal of the marketing authorisation.
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Legal Bases
Legal Bases
Section 29 Subsection 1b AMG
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.
Section 29 Subsection 1c AMG
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.
Section 29 Subsection 1g AMG
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.
Section 31 Subsection 1 sentence 1 No. 1 AMG (Sunset Clause)
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.
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Notification procedure for the "Sunset Clause"
Notification procedure for the "Sunset Clause"
Notification procedure relating to the “Sunset Clause” pursuant to Section 29 para. 1b and 1c AMG
Underlying information on the Sunset Clause
Based on the so-called Sunset Clause rule, marketing authorisations expire if a pharmaceutical company does not make use of the marketing authorisation over a period of three years. 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 (Sunset Clause: Section 31 para. 1 sentence 1 No. 1 AMG).
Pharmaceutical companies are obliged to notify the senior federal authority of the time of starting the marketing of a medicinal product as well as the temporary suspension or permanent cessation of placing on the market of a medicinal product (Section 29 para 1b and 1c). If the authority is notified of a cessation of placing on the market, this must be justified to the senior federal authority (Section 29 para. 1g).
The AMG lays down that the competent senior federal authority can permit exceptions to the rule of Section 31 para. 1 sentence 1 No. 1 AMG, if this is required for reasons of health protection to humans and animals (Section 31 para. 1 sentence 2 AMG).
FAQ on sunset clause notifications for centrally authorised medicinal products at the EMA
Are notifications for medicinal products centrally authorised by the EMA also to be submitted to the Paul-Ehrlich-Institut?
The notification procedure is only applicable for national authorisations that are in the responsibility of the Paul-Ehrlich-Institut. Medicinal products authorised via the centralised procedure are in the responsibility of the EMA. Therefore, for these, no additional notification has to be made to the Paul-Ehrlich-Institut.
FAQ concerning permitted the exceptions to the Sunset Clause
Does the marketing authorisation expire if a medicinal product authorised within the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP), and for which Germany (DE) is the reference member state (RMS), if it was not (no longer) marketed in Germany in three successive years but is still required in at least one concerned member state (CMS)?
Based on the Sunset Clause rule, the marketing authorisation expires in Germany in principle if the medicinal product has no longer been marketed in Germany in three successive years.
However, an application can be submitted for a permission for an exception pursuant to Section 31 para. 1 sentence 2 AMG provided that the medicinal product is still marketed in at least one CMS. The application for a permission for an exception must be submitted in time before the marketing authorisation expires pursuant to Section 31 para 1 sentence 1 No. 1 AMG.
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Justification for cessation of placing on market
Justification for cessation of placing on market
Justification for the cessation of placing on the market pursuant to Section 29 para. 1g AMG
Pursuant to Section 29 para. 1g AMG, the marketing authorisation holder is obliged to notify the competent senior federal authority without delay of the reasons for
- the temporary or permanent cessation of placing on the market of a medicinal product,
- the recall of a medicinal product,
- the renunciation of a marketing authorisation,
- a non-application for a renewal of the marketing authorisation.
Notification of the reasons
In the notification, the marketing authorisation holder must in particular explain whether the measure taken is based on one of the following reasons:
- Section 25 para. 2 sentence 1 No. 3 AMG: The medicinal product is not manufactured conforming to the recognised pharmaceutical rules and does not show the appropriate quality.
- Section 25 para. 2 sentence 1 No. 4 AMG: The medicinal product lacks the indicated therapeutic efficacy or the latter does not have a sufficient basis in accordance with the currently secured state of scientific knowledge.
- Section 25 para 2 sentence 1 No. 5 AMG: The benefit/risk ratio is unfavourable.
- Section 30 para. 2 sentence 1 No. 1 AMG: Withdrawal of the marketing authorisation because of incorrect or incomplete information in the documents pursuant to Sections 22, 23, or 24 AMG or if reasons for a rejection exist pursuant to Section 25, para. 2 No. 6a or 6b AMG during the marketing authorisation procedure.
- Section 69 para. 1 sentence 2 No. 4 AMG: Justified suspected damaging effects, which exceed the extent acceptable in accordance with the findings of medical science
- Section 69 para. 1 sentence 2 No. 5 AMG: Required quality controls have not been performed.
The marketing authorisation holder is also obliged to inform the competent senior federal authority if the measure was taken in a third country or is based on one of the above reasons.
The background of the notification obligations pursuant to Section 29 para 1g AMG is that a voluntary withdrawal from the market on the part of the marketing authorisation holder shall not cause concerns with regard to the risks and benefits of a medicinal products in the meaning of Articles 116 and 117 para 1 of Directive 2001/82/EC to be inadequately taken into account.
Informing the European Medicines Agency
If one of the explicitly above stated reasons exists, 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.
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How to Submit Notifications
How to Submit Notifications
Electronic notification procedure
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
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
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