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Order a certificate of free sale to export medical devices outside the UK.
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
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.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Food and drink labelling and packaging regulations - what you must show, warnings, health and organic labels and packaging standards.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
Advice for manufacturers of Class I medical devices for placing products on the UK market
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2024) approved the medicine fosdenopterin (Nulibry) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A
Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or...
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
You can claim relief on Customs Duty and VAT if you're importing scientific materials and apparatus for education or research to the UK.
Approval of a change to the licence of Comirnaty COVID-19 vaccine will enable thawing and re-labelling of the vaccine outside of the NHS
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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