New Products
New veterinary medicines can be marketed in Ireland only when they have been evaluated and granted a marketing authorisation. There are two main routes for licensing a medicine:
- Centralised EU-wide evaluation: Conducted by the European Medicines Agency (EMA), with authorisation granted by the European Commission.
- National evaluation: Conducted by the HPRA, with authorisation granted by the HPRA.
Our role:
The HPRA is responsible for regulating and monitoring the quality, safety and efficacy of veterinary medicines in Ireland. Our tasks include:
- Reviewing the quality, safety and efficacy data in the application dossier.
- Ensuring that the manufacturer has the necessary manufacturing licence.
- Verifying the clarity of product labelling and package leaflet, supported by evidence from the dossier.
- Publishing assessment outcomes on our website and the EU’s Union Product Database.
Additionally, we participate in the evaluation of applications submitted for central authorisation to the EMA. We also act as ‘Reference Member State’ in the Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP), to assist applicant companies in gaining marketing authorisations in other EU Member States.
Decentralised and Mutual Recognition Procedures (DCP / MRP):
Applicants wishing to use the HPRA as the RMS and looking to book a DCP time slot should submit completed request forms to vetinfo@hpra.ie, attention of the Planning and Authorisations Manager. Having considered our advanced booking list and resources, we will respond as soon as possible. Please note that late cancellations / postponements may free up slots previously marked as unavailable.
For further information on DCP / MRP submissions, please refer to our Guide to Decentralised and Mutual Recognition Procedures for Veterinary Medicinal Products using Ireland as RMS.
Licensing in Ireland only – National Applications:
For national applications for veterinary medicines in Ireland only, submit completed request forms to vetinfo@hpra.ie, attention of the Planning and Authorisations Manager. We will respond regarding acceptance or refusal of the application proposal as soon as possible.