The Paul-Ehrlich-Institut publishes refusals of marketing authorisations and approvals and withdrawals of applications for marketing authorisation and for approval, including the reasons for the refusal. The legal basis is section 34 subsection 1b sentence 1 of the Medicinal Products Act (Arzneimittelgesetz, AMG).
The second act amending medicinal and other regulations within the AMG on 19 October 2012 (Federal Law Gazette I p. 2192) came into force on 26 October 2012. This act requires that the withdrawal of an application for marketing authorisation for a medicinal product intended for use in humans as well as the refusal of marketing authorisation for such a product and the reasons for this refusal be made accessible to the public. This applies to applications for approval of tissue preparations and haematopoietic stem cell preparations made from peripheral blood or from umbilical cord blood pursuant to AMG section 21a and for applications for approval of advanced therapy medicinal products pursuant to AMG section 4b (AMG section 21a subsection 5 sentence 3 and section 4b subsection 3 sentence 2).
The Paul-Ehrlich-Institut fulfils this obligation by publishing the relevant information. It only provides information on the medicinal products for which the Paul-Ehrlich-Institut is responsible pursuant to AMG section 77 par. 2.
Decisions by the Paul-Ehrlich-Institut on the refusal of marketing authorisations or approvals are published together with the reasons for which the decision has been made. The Paul-Ehrlich-Institut will indicate any decisions that are not yet enforceable. In individual cases, the reference to the enforceability pursuant to AMG section 34 subsection 1d may not be completely up-to-date, since in the event of legal action the court will only inform the Paul-Ehrlich-Institut after a claim has been received. Withdrawals of applications for marketing authorisation or approval are commercial decisions and are not made by official authorities. The Paul-Ehrlich-Institut is not privy to the commercial purposes for which an application is withdrawn. Information regarding enforceability is also omitted.
The Paul-Ehrlich-Institut checks the withdrawals and refusals at the end of each month. A new version of the list is only published if changes are necessary.
Updated: 08.05.2025
