When preparing submissions for medicinal products for human use, the most important question that sponsors, study nurses and CRAs need to answer is which German authority is responsible for processing their application. Especially, if it is the first time that you are in charge of a submission you might be in doubt as to whether you need to contact the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul-Ehrlich-Institut (PEI).
Luckily, section 77 of the German Medicinal Products Act (AMG) clearly defines the areas of responsibility of both authorities, stating that the BfArM is responsible for all submissions that do not fall into the area of expertise of the PEI. Number 2 of section 77 lists all medicinal products for which the PEI is competent:
“[…] sera, vaccines, blood preparations, bone marrow preparations, tissue preparations, tissues, allergens, advanced therapy medicinal products, xenogeneic medicinal products and blood components manufactured using genetic engineering.”
(Section 77 (2) AMG)
Once you have identified the authority that is responsible for your application you only need to find out which application procedure you should choose. There are four different procedures: the national procedure in accordance with Sections 21ff AMG and three European procedures: the centralised procedure, the Mutual Recognition Procedure (MRP), and the Decentralised Procedure (DCP).
You can choose the National Procedure if the medicinal product in question shall only be marketed on the German market. If you are aiming at obtaining a marketing authorisation in several EU member states at the same time, you can choose between the Mutual Recognition Procedure or the Decentralised Procedure. The Centralised Procedure should be used if you plan to market your medicinal product in all member states of the European Economic Area (EEA). In this case, the application is to be submitted to the European Medicines Agency (EMA).
As the Brexit is casting its shadow, there might also be consequences for applications within the EU and the EEA. The higher federal authorities BfArM and PEI both provide information about their Brexit preparations.
That’s a piece of cake, right? If nevertheless you are ever uncertain when it comes to submissions, our Regulatory Affairs department will be glad to help.