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Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for in…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
Funding of £85 million will be announced at a global event to support the international community in tackling the growing threat of antimicrobial resistance.
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and…
Two pharmacists who sold ‘industrial’ quantities of Class C controlled drugs were yesterday sentenced to two years’ imprisonment each, suspended for 24 months, at Southwark Crown Court following an investigation by the Crimi…
MHRA performance metrics for clinical trials and established medicines assessment.
Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V.
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
List of Field Safety Notices from 6 to 10 May 2024.
Marketing authorisations granted in 2024
Parallel import licences granted in 2024
List of Field Safety Notices from 29 April to 3 May 2024.
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