After the granting of a marketing authorisation, veterinary medicines must continue to meet the requirements for safety and efficacy and offer an acceptable balance between their benefits and risks.
To fulfil this objective, a pharmacovigilance system is in place, the purpose of which is to monitor veterinary medicines marketed in Ireland and to ensure that pharmacovigilance data, in particular about adverse reactions in treated animals, is collected and scientifically evaluated.
In addition to the monitoring of suspected adverse reactions in the treated animal(s), the scope of veterinary pharmacovigilance covers other aspects of post authorisation surveillance including: suspected adverse reactions associated with extra-label use; lack of expected efficacy of a veterinary medicinal product when used in accordance with label recommendations; surveillance of resistance; surveillance of environmental impact; violations of approved residue limits; and, harmful and unintended effects in humans.
The current legal framework for the pharmacovigilance of veterinary medicinal products is set out in Council Regulation (EEC) No. 2309/93, Commission Regulation (EC) No. 540/95 and Directive 2001/82/EC of the European Parliament and of the Council. This legislation describes the respective obligations of the person responsible for placing the medicinal product on the market (the Marketing Authorisation Holder (MAH)) and the Competent Authorities with respect to collecting, collating and evaluating information about the safety of veterinary medicinal products under actual use conditions.
Furthermore, with the adoption of the Animal Remedies Regulations 1996, there is now a legal obligation on veterinary surgeons, pharmacists and other persons licensed to sell or supply animal remedies to notify the IMB of all suspected adverse drug reactions (SADR) that come to their attention. When the source of a report is other than a health care professional, it is recommended that the advice of a veterinary surgeon be sought prior to reporting to ensure that the information provided is accurate and comprehensive. On the basis of the information presented, by both the reporter and the MAH, an assessment of the likely causal relationship between the administration of the suspected product(s) and the reaction(s) reported is made by the Competent Authority. Should a pattern of adverse reactions involving a specific product emerge, regulatory action may be initiated.