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What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Upper Tribunal Administrative Appeals Chamber decision by Judge Wikeley on 1 July 2024
Check the tariff classification for a defined daily dose of active substances.
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.
Information on the large programme uplift, which applies to high quality, larger study programmes that provide students with additional stretch and challenge.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Advice for medical professionals to follow when assessing drivers with neurological disorders.
Employment Appeal Tribunal Judgment of Mrs Justice Eady, Mrs Gemma Todd, and Dr Gillian Smith on 15 July 2024.
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.
The way you apply to licence biological products has changed
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Find out which types of food are zero-rated and which are standard-rated for VAT purposes.
You can claim relief to pay no Customs Duty and VAT if you're importing therapeutic substances of human origin, blood-grouping or tissue-typing reagents, or related packaging, solvents and accessories.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information for post-16 institutions considering expressing an interest to deliver the first 3 T levels in 2020 to 2021 academic year.
Upper Tribunal Administrative Appeals Chamber decision by Judge Mitchell on 4 July 2024
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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