Active Substance Registrations

The registration process for companies as required by Directive 2011/62/EU (Falsified Medicines Directive), began on the 2 January 2013. National Legislation was transposed on 22nd May 2013.

Below you will find a link to a Registry of Active Substance Manufacturers, Registry of Active Substance Importers and a Registry of Active Substance Distributors.

The contents of the registries are believed to be correct at the time of compilation.  It is important to note that this information may be updated several times within a month.  While every effort is made to ensure the accuracy of the information, it is not possible to guarantee that it is complete, accurate and up-to-date. If errors are brought to our attention, we will investigate them immediately. These lists have been made available for information purposes only.

This information was last updated on 21 March 2019 
API Manufacturer Approved List 20.05.19
API Importer Approved List 14.06.2019
API Distributor Approved List 24.06.2019
To see the Registry of Brokers of Finished Medicinal Products please see our Information for Brokers page