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Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Explanation of what Pharmacovigilance means and who is responsible. These documents must be read with the Implementation Explainer at VMD Information Hub.
How authorised veterinary medicines, products supplied under the cascade and products used under the Veterinary Medicines Internal Market Scheme and Veterinary Medicines Health Situation Scheme can be advertised.
The Veterinary Medicines Regulations require wholesale dealers in Great Britain to adhere to Good Distribution Practice for all distribution processes.
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
Information on BTV-3 vaccines including permits and licences.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
How to register veterinary practice premises for veterinary surgeons to supply veterinary medicines.
Benefit-Risk Submission Report (BRSR) and Pharmacovigilance Sales Submission (PSS) templates and guidance for completion of BRSRs, PSSs and signal notifications.
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.
Guidance on medicines for food and non-food horses and record keeping requirements including the horse passport.
Placing a veterinary medicine on the market, including non-medicinal products, how to obtain advice and report non-compliance.
How to submit an application, data package and responses for proposed or existing marketing authorisations.
Summary of product characteristics for Bultavo-3 BTV-3 vaccine in the UK
How to obtain an authorisation to wholesale veterinary medicines.
Legal requirements for the sale of veterinary medicines on the internet and the VMD Accredited Internet Retailer Scheme (AIRS).
How a marketing authorisation holder should report a defect with a veterinary medicine.
Effective from 17 May 2024 Definitive fees charged for applications under Schedule 7 of Veterinary Medicines Regulations 2013 (as amended) as they apply to GB.
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