Stringent safety criteria are imposed during the evaluation of the medicine. The submitted dossier of data, which supports this assessment, is the end result of years of discovery, pre-clinical laboratory development and clinical field trials.Ī marketing authorisation will only be granted if the experts, either at the VMD in the UK or EMA for products seeking EU-wide approach, and their advisory committees of independent experts (the Veterinary Products Committee (VPC) in the UK or Committee for Veterinary Medicinal Products (CVMP) in Europe), are fully satisfied (11, 12). The aim of an independent scientific assessment, for a marketing authorisation, is to evaluate the safety profile, the quality of the manufactured product and the effectiveness of the product. This information helps the national and European regulators to carry out an independent scientific assessment to ensure that all the regulatory criteria have been met. The process of applying for an MA includes the submission of an extensive and detailed dossier, which consists of data that supports the safety, quality and efficacy of the product in accordance with the legal framework. The discovery, research and development of an animal medicine is a lengthy and very expensive process with successful products taking 5-11 years to reach the marketplace (10).
COMPENDIUM OF VETERINARY PRODUCTS REGISTRATION
Rigorous European and UK standards for the registration process ensures only those medicines that meet defined standard of quality, safety and efficacy are authorised. This takes the form of a Marketing Authorisation (MA). The Authorisation of Veterinary Medicinesīefore an animal medicine can be placed on the UK market it must be approved. The enforcement division of the VMD proactively takes action, which can include prosecution, against any illegal marketing and use of unauthorised products in relation to breaches of the VMR (9). Only authorised veterinary medicines can legally be used in the UK. This scheme ensures that the UK meets an EU regulatory requirement to analyse samples for residues of veterinary medicines (7).įor all authorised veterinary medicines, there is an ongoing process of safety and efficacy monitoring – called pharmacovigilance – that ensures the continued safe use of effective medicines (8). meat, milk, eggs) is monitored through a statutory residue surveillance scheme (6). When veterinary medicines are administered to farm animals, the safety of food from these animals and their products (e.g.
On farm, there is a legal requirement, under the VMR, to record all veterinary medicines obtained and used in food-producing animals (1). all antibiotics are POM-V (prescription only medicines – through a veterinary surgeon). antibiotics are only available on prescription from a veterinary surgeon i.e. In the UK, animal medicines can be classified based on their authorised supply route, which allows for control over the sale and distribution of medicines e.g. This ensures that animal medicines are safe to use, they are efficacious (effective) and they meet quality criteria. Scientific studies by animal medicine companies and subsequent evaluation, by independent regulatory authorities, ensure that each authorised veterinary medicinal product meets the required standard of safety, efficacy and quality. At the EU level, the European Medicines Agency (EMA) is responsible for the scientific evaluation and monitoring of medicines (4).Īll of the authorised veterinary medicines available in the UK for animals must undergo a strict regulatory approval process, before they gain a Marketing Authorisation (MA) or licence for sale and supply (5). In the UK, the national competent authority and independent regulator is the Veterinary Medicines Directorate (VMD) (3). Additionally, there are a range of EU regulatory controls that also apply to veterinary medicinal products (VMPs) including controls on safety, licensing and monitoring (2). In the UK, the Veterinary Medicines Regulation (VMR) provides for legislative requirements concerning the manufacture, classification, supply, marketing and use of veterinary medicines (1). These comprehensive controls ensure that safe, effective and quality veterinary medicines are available for the health and welfare of our animals, whilst safeguarding people and the environment. This document provides an overview of the broad range of regulatory controls that are in place governing the authorisation, supply and monitoring of veterinary medicinal products.