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.