1. All veterinary medicines authorised by the IMB are evaluated for conformance with the prescribed quality, safety and efficacy standards. The standards are established mainly by EU legislation. The interpretation of the standards is facilitated and harmonised throughout the European Union by means of guidance notes, established by the European Medicines Agency (www.ema.europa.eu). The IMB also takes into consideration the approach of the European Medicines Agency in relation to products recommended for authorisation by that body, as well as European case law, applicable European monographs and national legislation, and IMB policy.
Information relating to dossier requirements (Notice to Applicants) can be found on the European Commission website. Further guidance documents relating to the conduct of certain quality, safety and efficacy studies are available on the website of the European Medicines Agency. Labelling requirements for products authorised and marketed in Ireland are detailed in the Animal Remedies Regulations, 2007 (S.I. no. 786 of 2007).
2. All veterinary medicines must be manufactured in accordance with Good Manufacturing Practice. The IMB is responsible for inspecting and licensing manufacturers of veterinary medicines produced in Ireland. The products released onto the market from a licensed manufacturer must meet their finished product specifications. A ‘qualified person’ employed by the company is responsible for ensuring that all products meet their specifications prior to release from the manufacturing site.
3. Veterinary medicines are extensively tested prior to being authorised. However, in the first four years following authorisation the products are also subjected to intensive monitoring to ensure that the benefit/risk balance remains positive. Information from the field or clinic regarding any side-effects or interactions arising from experience in use is collected and analysed by the IMB and other European regulatory authorities. Where the benefit/risk balance has changed or new risk minimisation measures are deemed appropriate, the IMB can instruct the company involved to amend or expand the precautions for use. For further details see Safety Monitoring section of our website.
Following the decision to grant a marketing authorisation, the authorisation remains valid for a period of five years. Thereafter, following renewal, the marketing authorisation generally has an indefinite validity.
4. Information on all veterinary medicines that have been authorised by the IMB is available from the product listings section of the IMB website. This information is usually referred to as the ‘Summary of Product Characteristics’ (SPC). The IMB publishes this content within two weeks of the date of authorisation. If you require the information urgently or you believe that there is a problem or error in the information please contact the Veterinary Medicines Department at email@example.com. In accordance with national legislation the IMB publishes a list of newly authorised products in Iris Oifigiúil.
5. There are approximately 1150 individual veterinary medicines authorised by the IMB.