The IMB is primarily tasked with the authorisation and monitoring of veterinary medicines which are subject to product marketing authorisation in Ireland. The responsibilities may be categorised into several areas: 

1. Reviewing information relating to the quality, safety and efficacy of veterinary medicines, including:

• Evaluating data submitted for national authorisation
• Evaluating data submitted for authorisation to the European Medicines Agency(www.ema.europa.eu) Evaluating data on residues of veterinary medicines in food-producing animals to allow for the derivation of EU approved maximum residue limits
• Determining the method of supply of veterinary medicines authorised in Ireland 

2. Participating in the elaboration of standards and policies relating to the quality, safety and efficacy of veterinary medicines in the European Union, through:

• Participation in the scientific regulatory committees of the EMA
• Knowledge sharing with organisations involved in the EU network of medicines agencies on issues relating to the quality, safety and efficacy of veterinary medicines
• Participating in other EU or global bodies involved in setting standards for veterinary medicines including EDQM (www.edqm.eu) and VICH (www.vichsec.org)

3. Continually monitoring the benefit risk balance of veterinary medicines in Ireland, including:

• Evaluating reports of suspected adverse reactions submitted nationally
• Reviewing periodic safety update reports relating to use of the medicines in Ireland and overseas
• Collaborating with colleagues from other medicines agencies to ensure timely and coordinated regulatory actions, as necessary, to safeguard animal and human health
• Reviewing scientific literature, reports of government and international bodies on animal health and consumer protection for potential impact on the safety and efficacy of veterinary medicines authorised in Ireland
• Reviewing the EMA database of adverse reactions for possible data trends
• Reviewing EU and international developments on antimicrobial resistance
• Collecting information on the usage of veterinary antimicrobial substances in Ireland
• Implementing decisions of veterinary medicines which are required by the EU Commission in order to safeguard animal health and welfare in Member States

4. Other national regulatory activities on veterinary medicines including:

• Deciding the classification of borderline products either as being veterinary medicines or not
• Providing advice to the Irish Department of Agriculture, Food and the Marine on the regulation of veterinary medicinal products and related matters.
• Contributing to the EU’s FVO system for audit of the national residue plan
• Auditing of company pharmacovigilance systems

5. Supporting the elaboration of a suitable regulatory environment for veterinary medicines which meets the needs of animal health and welfare and the protection of public health in Ireland through:

• Information-sharing with the Irish Department of Agriculture, Food and the Marine 
• Developing assessment reports for application procedures to share with other EU medicines agencies
• The elaboration of maximum residue limits for drugs which might be detected in food commodities but which are not of commercial interest for industry
• Communications with health-care professionals and interested parties
• Contributing to the EU medicines agencies network to optimise resources and knowledge-sharing in the network
• Contributing ideas in relation to the introduction or modification of legislation in the area

In accordance with national legislation, the IMB is expected to cover the costs of providing its services through charging fees for its work.    

Regulatory activities outside the scope of the IMB’s Veterinary Medicines Department  

The following activities are carried out by the Department of Agriculture, Food and the Marine:

• Licensing of veterinary wholesalers and retailers in Ireland
• Elaborating new legislation (although the IMB may be consulted in this regard)
• Licensing autogenous vaccines
• Licensing feedmills to medicate animal feeds
• Prosecuting offences under national legislation governing the sale or supply of animal remedies
• Regulating the importation of veterinary medicines which are licensed in other EU Member States
• Licensing veterinary medicinal products for exceptional use under Articles 16, 17 and 18 of SI No 786 of 2007
• Providing advice regarding any proposed use of a veterinary medicinal product outside its authorised conditions of use
• Controlling the advertising of veterinary medicines
• Licensing clinical trials on veterinary medicines (although the IMB may be consulted by the Department in this regard)  

The IMB does not operate a laboratory to test veterinary medicines but does have agreements in place with specialist laboratories regarding its ongoing role in monitoring the quality of veterinary medicines authorised nationally.  

We are also part of a wider network of EU medicines agencies which cooperate on the sharing of information on tests conducted on medicines.