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Authorisations for Veterinary Medicines

All marketing authorisations, homeopathic remedies, and specified feed additives published in the Product Information Database on GOV.UK.

Assessment of autogenous vaccines, equine stem cell centres and non-food animal blood banks

Good Manufacturing Practice Inspections Team (GMPIT) contribution to these assessments

Analysis of animal usage in batch release tests

Reports on statistics of animal usage in batch release tests for immunological products

Antimicrobial Resistance surveillance data

Antimicrobial Resistance (AMR) data gives the results of antimicrobial sensitivity testing on Salmonella isolates from samples collected from poultry and other animal species under the statutory...

VMD internal service performance reports

Monthly performance reports on Veterinary Medicines Directorate (VMD) internal performance

Assessment Reports on applications for veterinary medicines

Assessment reports for national Marketing Authorisation applications and applications dealt with under decentralised, mutual recognition, variations and renewal procdedures (For above data only...

Imported veterinary medicines

A list of details of the top 10 products for which Special Import Certificates were granted, naming the active ingredient and number of certificates.

Inspections and Investigations Team (IIT) Inspection reports of inspections of approved businesses and registered Veterinary Practice Premises

Typed reports and handwritten 'Confirmartion Of Inspection Reports' issued to a business after an inspection has taken place.

Pharmacovigilance data about most commonly reported adverse reactions and lack of efficacy broken down by veterinary medicine type

Datasets providing information about the most commonly reported adverse reaction events and suspect lack of efficacy for difference classes of veterinary medicines.

Special Import/Special Treatment Certificates for imported use of veterinary medicines

These certificates are produced and released to the applicant upon approval of an application to import a medicine from outside the UK.

Veterinary Medicines Regulations (VMR) - consultation data

List of consultees for consultation exercises on the Veterinary Medicines Regulations (VMR) and related consultations.

Reports from the EU Committee of Veterinary Medicinal Products meetings (24 hour reports)

Veterinary Medicines Directorate (VMD) internal report of the EU Committee of Veterinary Medicinal Products meeting

Inspections and Investigations Team (IIT) Investigations notes of inspections of approved businesses and registered Veterinary Practice Premises

Details of investigations, including the source of information, the investigation procedure and the outcome, held on the Inspections Management System (IMS) database.

The Veterinary Medicine Directorate's Research and Development programme

Project proposals, peer review reports and interim reports

Veterinary Medicines Regulations (VMR) - enforcement data

Data on individual enforcement cases (e.g. Intelligence, information supplied/gatherered about possible breaches of the Veterinary Medicines Regulations (VMR)).

Inspections and Investigations (IIT) team inspection notes of inspections of approved businesses and registered Veterinary Practice Premises

Inspectors' inspection notes held on the Inspections Management System (IMS) database.

Good Manufacturing Practice Inspections Team (GMPIT) inspections of manufacturing premises of veterinary medicines

Material relating to Veterinary Medicines Directorate VMD inspections (e.g. Inspection reports, agendas, notes). The VMD's own internal inspection schedule.

Documents relating to the VMD's internal Alert Group which considers significance of pharmacovigilance data received on veterinary medicinal products

Results of proportinal reporting ration analyses and investigations into the signals detected.

Spontaneous adverse event reports following bad reactions to or lack of effectiveness of veterinary medicines

Individual case summaries of animals or humans reacting to veterinary medicines

Questions from companies seeking Marketing Authorisations for veterinary medicinal products as part of the assessment process

The General Assessment Team routinely receive queries from companies in relation to Marketing Authorisations. A summary Q&A document is on the VMD website to address generic frequently asked...