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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 apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Check the tariff classification for a defined daily dose of active substances.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Jan - 31 Mar 2024.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Check what side effects people have reported when they've taken a medicine.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
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.
How to prepare for implementation and compliance of the Safety Features Regulation.
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