Authorisations to market veterinary medicinal products are granted by the IMB under the European Communities (Control of Animal Remedies and their Residues) Regulations 2007 [SI no 786 of 2007]. A marketing authorisation that is granted by the IMB is known as a veterinary product authorisation (VPA).
Applications to the IMB 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 Reports
- Quality data
- Safety data
- Efficacy data
The documentation to be supplied is outlined in EU Directive 2001/82/EC, as amended, and in guidelines in Volume 7 of the Notice to Applicants and on the European Commission’s website.
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 MRP is used the product must first be authorised in one Member State (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, so in Ireland, a VPA is granted following a successful MRP.
If a marketing authorisation for the product has not yet been granted in any Member State, the applicant must make use of the DCP and submit an application in all the Member States where it intends to obtain a marketing authorisation at the same time, and choose one of them as RMS. 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 CMS are addressed by the company and should be resolved by day 210 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, so in Ireland, a VPA is granted following a successful DCP.
Full details on the mutual recognition and decentralised procedures can be found in the Notice to Applicants on the European Commission’s website.
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 medicinal product of a product that already has been centrally-authorised.
Applications under the centralised procedure are made to the European Medicines Agency. Further details are available on the European Medicines Agency’s website.