- Our aim is to make sure that veterinary medicines are as safe as possible and do what they are supposed to do.
- We grant licences for medicines following a review of their safety, quality and effectiveness. The decision to grant a licence is based on a review of applications submitted by pharmaceutical companies and involves an evaluation of the benefit/risk profile. All medicines have some risks associated with their use - known as side effects. However, the benefits of using a medicine should always outweigh the potential risks.
- For veterinary medicines, there are potential risks to:
- The animal itself,
- The user of the product e.g. the animal owner treating the animal, and,
- The animal’s environment potentially.
For food-producing animals, we also assess drug residue levels to make sure there are no implications for public health from residues in treated animals.
- Some veterinary medicines are licensed by the European Commission following the opinion of the European Medicines Agency (EMA). In this case they can be marketed throughout the EU. The decision to grant these licences is based on input into the evaluation by the national authorities, including representatives from the HPRA.
- Once a medicine is available in Ireland for use in animals, we continue to monitor its safety, quality and effectiveness. This involves the operation of a national reporting system for adverse effects and product quality, as well as an inspection programme to ensure the proper manufacture of the product.
- We encourage vets, other healthcare professionals and animal owners to report side effects, quality problems and other related issues to the HPRA through our website or by contacting us directly.
- When new safety or quality information emerges we ensure that vets and other healthcare professionals are informed and when necessary new prescribing and dispensing advice is issued. Where appropriate, we will also highlight this information to animal owners.
- Where we identify a significant safety or quality concern with a veterinary medicine, there are a range of regulatory actions we can take to protect animal and public health. These include changes to the product information, safety notices as well as suspensions or recalls.
- We also grant licences to the companies who make and market veterinary medicines in Ireland. This follows an onsite inspection to ensure compliance with relevant standards and legislation. Thereafter, we audit manufacturers on a regular basis as part of our on-going inspection programme. Wholesalers of veterinary medicines are inspected and licensed by the Department of Agriculture, Food and the Marine and we co-operate with the Department in this area.
- We are also responsible for regulating the use of animals for scientific purposes. Our role is to protect the welfare of animals and to promote the principles of the 3Rs - Replacement, Reduction and Refinement.
- We inspect and licence establishments where animals are bred, kept or supplied for use in scientific or educational purposes, in accordance with national and European legislation.
- We are also responsible for the licensing of clinical trials using new veterinary medicines in animals in Ireland. This task involves consultation with the Department of Agriculture, Food and the Marine regarding the nature of the product(s) under study. The licensing decision encompasses both the permission to carry out the study, as well as the permission to import and use any test products.