EU pharmaceuticals trading

Approval Procedures

Therapeutic identity is the law

There are two different methods in the field of drug approval.

National Approvals
Drugs which have a German approval can be imported from other EU countries. For this purpose Pharma Gerke has prepared a request for approval from the Federal Institute for Drugs and Medical Devices (BfArM). The BfArM verifies the therapeutic identity between the approved drugs in Germany and the respective EU country. With consent by the BfArM Pharma Gerke receives the approval to distribute these drugs in Germany.

European Approvals
This includes the approval of medicinal products through the European approving authority the European Medicines Agency (EMA) in London. These drugs are generally identical in the countries in which they are distributed.

The respective registration numbers are indicated on the packaging of the drugs.