34 datasets found

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

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

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

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...

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

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

Project proposals, peer review reports and interim reports

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

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

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

Individual case summaries of animals or humans reacting to veterinary medicines

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

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

Documents submitted by companies as part of their regulatory obligations, summarising all adverse events reported in a predefined period.