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Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
When entering the UK, you need to prove your medicine is prescribed to you if it contains a controlled drug - find out what proof you need to get.
How to make sure an application relating to an authorisation for a veterinary medicine is complete and will pass validation.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
As a marketing authorisation holder (MAH) report a current or foreseen UK supply problem with one of your veterinary medicinal products.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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