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How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
Section last updated: April 2024.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance on medicines for food and non-food horses and record keeping requirements including the horse passport.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
The following detailed requirements shall apply to veterinary medicinal products other than biological veterinary medicinal products, except where otherwise set out in Section IV.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
How a marketing authorisation holder should report a defect with a veterinary medicine.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
Advice on ingredients in nicotine-containing liquids in electronic cigarettes and refill containers.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Legal requirements and good practice guidance for Veterinary Practice Premises Inspections.
Requirements for Marketing Authorisation applications for particular veterinary medicinal products.
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