Non-qualifying Regulatory Provisions Summary Reporting Template

Regulator: Veterinary Medicines Directorate

Business Impact Target Reporting Period Covered: May 2015 – April 2016

Excluded Category* / Summary of measure(s), including any impact data where available**
L1 – Casework / Authorisations of veterinary medicines
We issued 148 marketing authorisations for veterinary medicines, and 31 animal test certificates for clinical trials for veterinary medicines. We also issued one authorisation for an autogenous vaccine authorisation.
Enforcement action
We issued 255 warning letters and 171 advisory letters relating to illegal veterinary medicines. We also issued 5 Seizure notices, 10 Improvement notices and referred 28 cases to our investigation team for further investigation
We also completed 346 cases relating to medicinal claims for unauthorised medicinal products.
Inspections carried out:
  • 221 Feed Business Operators
  • 390 SQP retailers
  • 533 Vet practice premises
  • 43 veterinary medicines manufacturing sites
  • 52 veterinary medicines wholesale dealing sites
Pharmacovigilance:
We processed 5,743 reports of adverse events from veterinary medicines.
Import Certificates issued (certificates to authorise veterinary surgeons to import unauthorised medicines):
17,046 certificates
Exports Certificates for veterinary medicines issued
577 certificates
Residue sampling programme
The programme to take and analyse samples from food producing animals and their products for residues of veterinary medicines and prohibited substances.
Samples taken - 29,454
Non-compliant results - 103
L2 – Education, communications and promotion / Publicity events
We attended 7 events with our VMD publicity stand, including 4 events specifically for veterinary surgeons and nurses, one for pharmacists, one for the general public and one for animal health product distributors.
We also issued three editions of our enforcement newsletter to interested stakeholders which included facts and figures on enforcement work carried out.
One of our inspectors wrote 5 educational articles for a magazine specifically aimed at retailers of veterinary medicines.
Antimicrobial resistance
We carried out three sector engagement forums on antimicrobial resistance for:
  • companion animal & equine
  • camelid and small Ruminant
  • fish
We participated in the European Antibiotic Awareness Day / World Antibiotics Awareness Week (both in November) and we highlighted these initiatives by:
  • Writing articles for vet press, animal magazines (e.g. cat, pigeon, dog)
  • Putting out messages through Defra social media
We held our second Antibiotic Resistance Summit, a high level summit for key representatives across animal sectors and government.
L4 – Changes to management of regulator / Our Director of authorisations, Jackie Atkinson, left the VMD and was replaced by Marie-Odile Hendrickx.