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How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Fees payable to the MHRA for 2023 to 2024
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How the MHRA processes variations to Marketing Authorisations (MAs)
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
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.
Medicines and Healthcare product Regulatory Agency official Parental Leave policy and procedures.
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.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
This guidance summarises our approach to pharmacovigilance
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
This guidance explains the legal framework for labelling and packaging as described in UK legislation and gives best practice for producing medicines labelling and packaging.
Keep up to date with the latest information from the UK GLP monitoring authority.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
How to change the ownership from one marketing authorisation (MA) holder to another.
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.
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