New legal regulations governing the application of ATMPs

The German Act for more Safety in the Provision of medicinal products (‘Gesetz für mehr Sicherheit in der Arzneimittelversorgung’/ GSAV) of 9 August 2019 will create more transparency in the (German) Medicinal Product Act (‘Arzneimittelgesetz’/ AMG) with regard to advanced therapy medicinal products (ATMP) which do not require a marketing authorization or any other authorization for the placing on the market (pursuant to Section 4b AMG (hospital exemption)). These special kind of ATMPs preparations are manufactured and also used by a treating person on a patient individuel basis without a change in the actual power of disposal over the drug.

From 15 August 2020, treating persons who apply ATMPs which do not require a marketing authorisation or any other authorization are obliged to notificate and document suspected adverse reactions. In addition, in the future, the use of these ATMPs have to be reported to the competent higher federal authority.

Valicare will assist you in implementing these new requirements as your competent partner. Contact us and we will be happy to support you!

You can find a comprehensive overview of these and other changes made by the GSAV here: 
https://www.bundesgesundheitsministerium.de/gsav.html

Find out also about our services on the subject of GMP for ATMPs