New Product Application
The HPRA grants authorisations to market veterinary medicines under the European Communities (Control of Animal Remedies and their Residues) Regulations 2007 [SI no 786 of 2007]. Every application for authorisation is given a unique number known as a veterinary product authorisation (VPA).
Applications for a new marketing authorisation consist of:
- Administrative data, including the standard EU Part IA application form
- Summary of Product Characteristics (SPC)
- Product label and package leaflet
- Expert Summaries
- Quality data
- Safety data
- Efficacy data
The documentation to be supplied is outlined in EU Directive 2001/82/EC, as amended, in EU Directive 2009/9/EC and in guidelines in Volume 6 of the notice to applicants. Additional information can be found on the EMA website.
If a product is to be licensed in Ireland only a national application can be submitted. If a product is to be marketed in more than one Member State, the mutual recognition procedure (MRP) or decentralised procedure (DCP) must be used.
If the product is already authorised in one Member State, MRP must be used. The country in which it is authorised is called the Reference Member State (RMS). Using this authorisation, the applicant applies to other 'concerned' Member States (CMS) to 'mutually recognise' the authorisation of the RMS. The RMS provides an assessment report and the CMS may accept it or raise public or animal health concerns within 54 days of the start of the procedure. Any concerns raised by CMS are addressed by the company and should be resolved by day 90 of the procedure, following which marketing authorisations will be issued by the CMS. The marketing authorisations which are granted in each CMS are national authorisations.
If a marketing authorisation for the product has not yet been granted in any Member State, the applicant must make use of the DCP if they wish to obtain an authorisation in more than one member state. The applicant requests one Member State to act as RMS and submits the application simultaneously to all member states involved. The RMS provides an assessment report and the CMS may accept it or raise public or animal health concerns within 100 days of the start of the procedure. Any concerns raised by the RMS and CMS are addressed by the company and should be resolved by day 210 of the procedure. Marketing authorisations are then issued by the CMS. The marketing authorisations which are granted in each CMS are national authorisations.
HPRA as Reference Member State in the Decentralised and Mutual Recognition Procedures
The EU centralised procedure is the obligatory procedure to obtain a marketing authorisation for products referred to in the Annex to Regulation (EC) No 726/2004 as amended. The same procedure may be used by applicants in respect of:
- Applications relating to products containing new active substances,
- Products which constitute a significant therapeutic, scientific or technical innovation or products for which the granting of an EU-wide marketing authorisation could be in the interest of animals in the EU.
- A generic medicine of a product that already has been centrally-authorised.
For the application for a time slot for veterinary medicinal products, completed request forms should be submitted to email@example.com for the attention of the Planning and Authorisations Manager.
We will respond via email regarding acceptance or refusal of a slot based on capacity, to the contact person mentioned on the request form as soon as possible.
Due to late cancellations / postponements, slots may become available where previously noted as ‘no resources available’ please contact us via firstname.lastname@example.org to check availability.
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.