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How a marketing authorisation holder should report a defect with a veterinary medicine.
Explainer for the pharmaceutical industry on the implementation of Pharmacovigilance requirements during the transition time from the date the revised VMR have effect in GB to 17 May 2027.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
How to submit an application, data package and responses for proposed or existing marketing authorisations.
Information on authorised vaccines and vaccination schedules for dogs.
Guidelines and guidance for vets, farmers and animal keepers on the responsible use of antimicrobials.
All national applications will be processed on one of six timetables that vary in length depending on the complexity and nature of the application under assessment.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
Clarification for the interpretation of the new elements within the Veterinary Medicines Regulations (VMRs), as amended, relating to combating antimicrobial resistance (AMR).
Apply for authorisation of premises for the retail supply of POM-VPS and NFA-VPS veterinary medicines by suitably qualified persons (SQPs).
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
The VMR sets out the statutory fees associated with various regulatory services provided by the VMD. The statutory fees and fee structure are implemented from 17 May 2024.
Information for farmers about inspections carried out on farms using on-site feed mixers to add veterinary medicines into feed.
Summary of product characteristics for BLUEVAC-3 BTV-3 vaccine in the UK
This document details the service standards of the Veterinary Medicines Directorate (VMD)
Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulation relating to Pharmacovigilance.
Guidance for vets, farmers and animal keepers on what the mg/PCU means and how it is calculated.
Register as a manufacturer, importer or distributor of active substances for use in veterinary medicines.
Legal requirements and good practice guidance for SQP retailers’ premises inspections.
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