VMD seeks views on cutting red tape
An ATC is required for clinical field trials of unauthorised veterinary medicines administered to patients in order to treat or prevent disease.
In a bid to cut costs and red tape, the Veterinary Medicines Directorate (VMD) is reviewing its approach to issuing animal test certificates (ATCs), which permit the use of unauthorised veterinary medicines in clinical field trials.
Responding to concerns raised during the Red Tape Challenge 2013, the VMD is proposing to change the way it issues ATCs for those intending to work under Recognised Veterinary Practice. It estimates the changes could save the industry more than £200,000 per year.
The changes would allow blood samples to be taken when a medicine is administered and at intervals throughout the trial, assuming this is being done for the benefit of the enrolled animal - i.e. the animal is being treated and the blood samples support that treatment.
Currently, an ATC is required for clinical field trials of unauthorised veterinary medicines administered to patients in order to treat or prevent disease, in accordance with Recognised Veterinary Practice.
The certificate permits the use of the medicine, allows it to be procured and supplied and also allows produce from treated animals to enter the food chain. The aim is to safeguard animals enrolled in the trial, those administering the treatment (i.e. the vet), those eating food products from treated animals and the environment.
For experimental studies (not carried out under Recognised Veterinary Practice), a licence is required from the Home Office under the Animals (Scientific Procedures) Act 1986 (A(SP)A). This will not change under the new proposals.
Under the current system, the VMD only considers a study to be a clinical trial carried out under Recognised Veterinary Practice if just one blood sample is taken. If more than one sample is taken, it is considered experimental and an A(SP)A licence is required. When in doubt, the VMD seeks the advice of the RCVS.
From 2009-2012, the VMD issued 76 ATCs for 31 different companies. It is anticipated that the number of applications would rise if the proposed changes go through.
To take part in the consultation, which runs until April 24, submit your views to d.burge@vmd.defra.gsi.gov.uk, or write to: Denise Burge, Veterinary Medicines Directorate, Woodham Lane, New Haw, Surrey, KT15 3LS. For more information see https://consult.defra.gov.uk/vmd/review-of-approach-to-issuing-an-atc
Companies marketing medicines for small pets exempt from authorisation must submit their annual return to the Veterinary Medicines Directorate (VMD) by 30 November 2026.
