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I WISH to respond to the helpful letter from Gordon Hockey of the RCVS on recognised veterinary practice and clinical trials (VR, June 20, 2015, vol 176, p 659-660).
Put simply, Directive 2010/63/EU concerns laboratory animal experimentation normally at an approved facility (under the Animals [Scientific Procedures] Act), but Directive 2001/82/EU (as amended) relates to veterinary medicinal products, including veterinary clinical trials in client-owned animals. The two Directives are written such that veterinary clinical trials are exempt from 2010/63 but addressed in 2001/82 and its related guidelines.
The Veterinary Medicines Directorate (VMD) is the UK competent authority regarding 2001/82/EU requirements for a marketing authorisation (MA), and regulates both Animal Test Certificates (ATCs) to permit clinical trials and MAs. Neither the RCVS nor the Home Office are the competent authority for this Directive or its related guidelines – and are not involved in their regulation. The Home Office is the UK …