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Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Information about new applications, post-licensing, advertising, product information and fees.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to prepare for implementation and compliance of the Safety Features Regulation.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
Guidance for industry on flexible approaches we are taking on good distribution practices.
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.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Jan - 31 Mar 2024.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
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