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.
The most recently published lists for active substance manufacturers, active substance importers and active substance distributors can be found on EudraGMDP.
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 (firstname.lastname@example.org).
Updates to active substance registrations – when to notify manufacture of a new active substance
The manufacture of new active substances is required to be included on the manufacturer’s Active Substance Registration (ASR). Different notification requirements ensue depending on the significance of the introduction of the new active substance to manufacturing activities.
The HPRA’s Guide to Managing Changes to Registration for Active Substance Manufacturers, Importers and Distributors gives further examples of changes requiring immediate notification and those that are required to be communicated by annual update. The guidance outlines supporting information to be submitted, including details of process validation studies performed or planned. Where the manufacture of an active substance meets the criteria to be communicated through an annual update, the update should be made after the completion of successful process validation. The application forms are available via the following links:
• Immediate notification
• Annual notification
Active substances under development or manufactured only for use in clinical trials do not need to be included in the ASR.