Active Substance Registrations

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

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

Please find the most recently published lists below:

API Manufacturer Approved List 1 August 2020

API Importer Approved List 3 June 2021
 
API Distributors Approved List 3 June 2021

To view the Registry of Brokers of Finished Medicinal Products, please see our Information for Brokers page.

From September 2020, the HPRA issued electronic authorisations with e-Signatures and do not routinely issue hard copies of Manufacturing Authorisations, Wholesale Distribution Authorisations and Active Substances Registrations.  Authenticity or integrity of electronic authorisations issued by HPRA, may be verified on the EudraGMDP database or alternatively enquiries can be submitted to the compliance mailbox (compliance@hpra.ie).