How do you know that the medicine you as a Vet prescribe is fit for use? There is a long history behind the system for ensuring that animal medicine won't kill the animal you are trying to treat!

First came the 1968 Medicines Act. It set the original standards for safety, quality and efficacy of animal medicines as well as human medicines. The eighties saw not just the ra –ra skirt and legwarmers but the first EU Directives covering animal medicines. 1994 saw the arrival of a network of official medicines control laboratories created by the commission of the EU and Council of Europe. These were designed to be a collaboration in quality control of human and animal medicines. However it was not until 2005 that regulation of veterinary medicines in the UK took its great leap forward. The Veterinary Medicines Regulations came in to force and covered all aspects of licensing and control of veterinary medicine. The Medicines Act was consequentially revoked in relation to veterinary medicines (although at the time of writing is still lumbering on in relation to many aspects of human medicines).

The Regulations are comprehensive. They ensure the following:-

  • that veterinary medical products have a marketing authorisation before being placed on the market and make provision for the grant of that authorisation
  • that the product must be manufactured by a person holding a manufacturing authorisation and make provison for the grant of that authorisation
  • regulation of the supply and possession of veterinary medical products
  • administration as specified in its marketing authorisation or in the case of administration by a veterinary surgeon under the rules of the cascade
  • wholesale dealing
  • medicated feeding stuffs and feeding stuffs containing additives
  • fees
  • records
  • offences

Since then the Regulations have been regularly amended. The latest amendment is 2011 and includes the implementation of EU Regulations on pharmacologically active substances and maximum residue limits in food stuffs of animal origin and enforcement relating to placing on the market, use and labelling of feeding stuffs containing specified feed additives. UK specific changes include introducing procedures and fees for giving formal advice as to whether a product requires a marketing authorisation. There are also fee updates.

The regulations are not the only mechanism for ensuring quality and consistency: Medicines are manufactured according to "Good manufacturing practice" (GMP) which is defined as "that part of quality assurance which ensures that medicinal products are controlled to the quality standard appropriate for their intended use." Details are set out in the Orange Guide produced by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Manufacturing Authorisations and MHRA's system of inspection also ensure that the people producing the medicines are following GMP. Part of the condition of obtaining a Manufacturing Authorisation is that GMP is followed

There is also a European Committee for medicinal products for veterinary use. It produces reports (on all question relating to veterinary medicinal products) and guidelines (form /function/rationale behind a product, packaging and manufacture)

Widening things out there is also the snappily named "International Co-operation on harmonisation of technical requirements for the registration of veterinary medicinal products". Which is an EU/Japan/US programme to harmonise technical requirements for veterinary product registration.

Nothing world wide yet....

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.