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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.
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.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Information about ensuring blood and blood component safety.
This guidance summarises our approach to pharmacovigilance
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.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
This advice has been written by the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) at the request of the Medicines and Healthcare products Regulatory Agency (MHRA – UK regulator). It is in the …
How to prepare for implementation and compliance of the Safety Features Regulation.
Keep up to date with the latest information from the UK GLP monitoring authority.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Medicines and Healthcare product Regulatory Agency official Parental Leave policy and procedures.
Guidance to help applicants and licence holders get and maintain a wholesale dealer licence (WDA(H)) or broker registration – MHRA guidance note 6.
How to change the ownership from one marketing authorisation (MA) holder to another.
This guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Register as a manufacturer, importer or distributor of active substances.
Guidance on whether or not your product is a medical device.
Don’t include personal or financial information like your National Insurance number or credit card details.
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