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Detailed guidance on advertising and promoting medicines.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How the MHRA processes variations to marketing authorisations.
Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
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.
How the MHRA makes decisions on what is a medicinal product (borderline products).
You must get permission to export certain drugs and medicines.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
How to use the procedure for medicines licensing applications.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
Information on comparator products used in studies supporting abridged marketing authorisation application.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
The review of the safety of isotretinoin has concluded.
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