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Register to vote Register by 18 June to vote in the General Election on 4 July.
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.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Information on road traffic devices, such as breath-testing, speed cameras and immobilisation devices.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
This document contains Other related Documents for FDA
Guidance on what approved bodies are, what they do and how you can become one.
Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended).
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.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
Rules for FDA.
Registers of authorised manufacturers, wholesale dealer sites and retailers.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
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.
Order a certificate of free sale to export medical devices outside the UK.
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public.
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