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Pharmacovigilance system requirements
Information about the EU Regulations and their implementation in Northern Ireland
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Information about ensuring blood and blood component safety.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
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 to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
Detailed guidance on advertising and promoting medicines.
Fees payable to the MHRA for 2023 to 2024
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
How to make a payment to MHRA by credit or debit card or a bank transfer.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to prepare for implementation and compliance of the Safety Features Regulation.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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