Paul-Ehrlich-Institut

Re­port­ing and No­ti­fi­ca­tion Obli­ga­tion for ATMPs

Obligation to notify the administration of an ATMP not subject to a marketing authorisation in a patient

Users of advanced therapy medicinal products (ATMPs), which do not require a marketing authorisation, will be obliged to report each administration of such an ATMP in a patient as from 15 August 2020.

The notification must be submitted to the competent authority, Paul-Ehrlich-Institut (PEI), without delay upon the start of treatment.

Contact

Email: eSubmission@pei.de

Legal framework

This notification obligation has its legal basis in Section 67 (9) German Medicines Act (Arzneimittelgesetz, AMG), and was created with the German Act Ensuring More Safety in Medicines Supply (Gesetz für mehr Sicherheit in der Arzneimittelversorgung, GSAV) of 9 August 2019. It applies to the administration of an ATMP as from 15 August 2020.

Failure to submit such a notification, incorrect submission, or delay of submission, either wilfully or negligently, constitutes an offence pursuant to Section 97 (2) No. 7 letter c) AMG. A penalty of up to 25,000 € can be imposed (Section 97 (3) AMG) for such offences.

Reporting of serious adverse reactions

The person administering the ATMP is obliged to notify the competent authority of the federal state (Landesbehörde) of all suspected cases of serious adverse reactions in the use of an advanced therapy medicinal product (ATMP) not subject to a marketing authorisation using the appropriate electronic form. The competent authority of the federal state will forward the notification to the higher federal authority, the PEI.

Contact

Email: pharmakovigilanz2@pei.de

Legal framework

This notification obligation has its legal basis in Section 63j, and was created with the German Act Ensuring More Safety in Medicines Supply (Gesetz für mehr Sicherheit in der Arzneimittelversorgung, GSAV) of 9 August 2019. It applies to use of an ATMP as from 15 August 2020.

Updated: 03.08.2020