Paul-Ehrlich-Institut

FAQ - Fre­quent­ly Asked Ques­tions

Miscellaneous

How long is a drug permitted to be marketed in Germany after the marketing authorisation has been waived?

According to Section 31 (4) of the German Medicines Act (Arzneimittelgesetz, AMG), a drug may be marketed for another two years after the expiration of the marketing authorisation by waiver of the marketing authorisation submitted by the marketing authorisation holder. The 2-year period begins on January 1 or July 1 following the announcement of the expiry (according to Section 34 AMG).

Updated: 24.02.2021