No. The time frame in accordance with Section 31 sub-section 1 number 1 AMG (Arzneimittelgesetz, German Medicines Act) is a statutory period. Therefore, no extension is possible.

No. The law requires that the medicinal product is marketed within the statutory period.

1. In cases in which the medicinal product cannot be placed on the market yet e.g. due to existing patents, the BfArM follows the EMA's view that the start of the 3-year period should be the date when the medicinal product can actually be marketed. See Notifying a change of marketing status question 5. under „Sunset-clause monitoring“ and NtA Volume IIa, Chapter 1 Section 2.4.2.
   These cases are not situations for which exemptions can be applied for in accordance with Section 31 sub-section 1 sentence 2 AMG. The marketing authorisation holder has to present significant documentation to the BfArM which conclusively supports the facts of the case. The notification obligations pursuant to Section 29 subsection 1c AMG and Section 141 subsection 7 AMG remain unaffected.
2. If a medicinal product was already on the market and the competent authority was subsequently informed of the interruption of marketing in accordance with Section 29 sub-section 1c AMG by the marketing authorisation holder, the period will start counting from the time the medicinal product is no longer being marketed. In this case, the marketing authorisation holder is to state the end of the shelf-life of the batch last placed on the market together with the notification of interruption of marketing in accordance with Section 29 sub-section 1c AMG.

In the case of pending or not legally effective applications for exemption pursuant to Section 31 sub-section 1 sentence 2 AMG, marketing authorisations do not expire until a legally binding decision has been made. In cases of a legally effective refusal of an application for exemption, the 3-year period applies. This means that even if the medicinal product has been placed on the market again in the meantime, the marketing authorisation has expired, if the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG was meanwhile exceeded.

1. It is the BfArM's view that the sunset clause period is suspended if the suspension of marketing authorisation was ruled for pharmacovigilance reasons. This suspension sets in automatically and is valid for the period of the ruling. The notification obligations pursuant to Section 29 subsection 1c AMG and Section 141 subsection 7 AMG remain unaffected. The sunset clause period is explicitly not suspended if the suspension of marketing authorisation was ruled for reasons of lacking proof of pharmaceutical quality.
2. It is the BfArM's view that the period can also be suspended under certain prerequisites, if the 3-year period is exceeded (e.g. due to long processing times of the national competent authority, in cases of pending appeal procedures and court actions or for similar reasons) but the medicinal products cannot be placed on the market due to the a.m. pending procedures. Together with the application for suspension of the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG, the marketing authorisation holder is to present relevant documentation demonstrating especially why the medicinal product could not be placed on the market with the current marketing authorisation status and that the marketing authorisation holder took all measures in due time in order to be able to actually place the medicinal product on the market before the end of the 3-year period.

The term "marketing" is defined in Section 4 sub-section 17 AMG as follows: "Marketing is the keeping in stock for sale or for other forms of supply, the exhibiting and offering for sale and the distribution to others".

It is the BfArM's view that a prerequisite for marketing is that the batch released medicinal product is marketed within the purview of the German Medicines Act. Thus, the export of the blistered tablets alone, for example, does not constitute a marketing of the licensed medicinal product as defined in Section 31 sub-section 1 sentence 1 number 1 AMG.

Yes. Since samples supplied by pharmaceutical entrepreneurs can be dispensed to physicians on the basis of Section 47 sub-section 4 AMG, they are also considered marketed within the definition of the AMG.

Yes, medicinal products used in clinical trials can also fulfil the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG.

Yes, generally the export of medicinal products can fulfil the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG. A precondition for this is that the batch release of the licensed medicinal product also has taken place within the purview of the AMG. Thus, the export of the blistered tablets alone, for example, does not constitute a marketing of the licensed medicinal product as defined by Section 31 sub-section 1 sentence 1 number 1 AMG. In this connection, the export refers only to the German marketing authorisation. However, from the BfArM's point of view, linguistic adaptation of the presentation as well as of the informative texts is possible.

If the medicinal product licensed in Germany is exported in accordance with the a.m. requirements, thus fulfilling the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG, no exemption pursuant to Section 31 subsection 1 sentence 2 AMG is necessary.

As a matter of principle, the end of the shelf-life of the batch last placed on the market by the marketing authorisation holder is counted.

In accordance with Section 29 sub-section 1b AMG, the marketing authorisation holder shall notify the competent federal higher 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.

In this connection, the term “immediately“ means that the authority is to be notified when the company has internally specified the precise date for placing the medicinal product on the market and not when it is actually placed on the market; however, the notification should be made no earlier than 4 weeks prior to placing on the market. Failure to notify the authority in due time constitutes an administrative offence in accordance with Section 97 sub-section 2 number 7a AMG.

No. Exemptions can only be granted for medicinal products for which there is a public interest to maintain the marketing authorisation on "public health grounds“, e.g. so that such medicinal products are available in the event of a disaster.

No. However, a suspension of the 3-year period can be applied for in such cases (for more information cf. Item A.5.).

Exemptions in accordance with Section 31 sub-section 1 sentence 2 AMG can also be granted for export to a third country for public health reasons. The same criteria as for national public health protection apply to the granting of such exemptions.

Such exemptions can be granted on a case-by-case basis provided the necessary requirements have been fulfilled. Together with the application, the marketing authorisation holder has to prove specifically that the medicinal product is authorised in at least one CMS.

As a rule, the decision on an exemption to the sunset clause is made on a case-by-case basis. Likewise, it is also dependent on the individual case for which period of time the exemption is granted. If the medicinal product is placed on the market again prior to the deadline stated in the BfArM's notice, the exemption to the sunset clause expires. After the deadline stated in the BfArM's notice, the national competent authority will verify upon request, whether the legal requirements for the exemption continue to be applicable.

Yes, in accordance with Section 39 sub-section 2c sentence 2 AMG, Section 31 AMG also applies correspondingly to the expiry of registrations.

Yes, in accordance with Section 105 sub-section 1 AMG these medicinal products are considered licensed. Section 105 sub-section 3a AMG defines the exemptions to Section 29 AMG. As these Sections do not include any specifications concerning the sunset clause, sub-sections 1b and 1c of Section 29 AMG also apply to the so-called fictively licensed medicinal products.

Only licenses within the jurisdiction of the BfArM are subject to the notification procedure. As the EMA is responsible for centralised marketing authorisations, the BfArM does not have to be informed.

No new notification is necessary if the granting of the marketing authorisation does not entail changes of the marketing status. This means that such a notification can be dispensed with if the medicinal product was marketed continuously.

No new notification is necessary if there are no changes in the marketing status. This applies to co-marketing as well as to transfer of licenses.

There is no longer a notification obligation for expired marketing authorisations. The prerequisite for such an obligation is an existing license. The renunciation of marketing authorisation in accordance with Section 31 sub-section 1 number 2 AMG results in the expiry of the marketing authorisation as of receipt of the written renouncement, i.e. the marketing authorisation which is the logical prerequisite for application of Section 31 sub-section 1 number 1 AMG no longer exists.

Yes, notifications in accordance with Section 29 sub-sections 1b and 1c AMG and with Section 141 sub-section 7 AMG are to be separated procedurally from the provisions of Section 31 sub-section 1 number 1 AMG. This means that the notifications have to be made for all medicinal products pursuant to the a.m. regulations. For marketing authorisations which have been suspended the "Date of cessation" as well as "End of shelf life" must not be later than the date from which the suspension was ruled. If the marketing authorisation of a medicinal product has been suspended, it shall neither be placed on the market, nor shall it be introduced into the purview of this Act pursuant to Section 30 sub-section 4 AMG.

No, when employing standard marketing authorisation or standard registration procedures no notifications have to be made via PharmNet.Bund application “Notifications for Sunset Clause”. Informations on the use of products for which either standard marketing authorisation or standard registration procedures are used can be found on the BfArM-website Standardzulassung und –registrierung or in the PharmNet.Bund application Standardzulassungen.

Questions not addressed in the FAQ or in the Explanatory Notes on Notification Procedures under the "Sunset Clause" can be sent to the e-mail address sunset-clause@bfarm.de .

For questions regarding registration or certificates please contact helpdesk-technik@bfarm.de .

Information on certificates, request access authorisation and user administration can be found in the PharmNet.Bund application Notifications for Sunset Clause.

An electronic application portal for exemptions and suspensions to the sunset clause was developed which should be used for submitting such applications. We expressly request to use this electronic procedure as opposed to conventional applications.

The PharmNet.Bund application “Sunset Clause - Exceptions”

It is recommended to submit these applications at least 3 months before, but in no event later than, the end of the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG. Applications received after this deadline can no longer be considered, as the marketing authorisations have already expired by law at this point in time.

Yes, in accordance with the currently valid Fees Ordinance (Besondere Gebührenverordnung BMG (BMGBGebV)) such notifications are subject to fees.

Yes, in accordance with the currently valid Fees Ordinance (Besondere Gebührenverordnung BMG (BMGBGebV)) such applications are subject to fees.