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Medicines and Healthcare products Regulatory Agency (MHRA)
The home of Medicines and Healthcare products Regulatory Agency on GOV.UK.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Find alerts and recalls issued by MHRA
Foam strip on the mask can flake and enter the wearer’s airway or mouth; ties and/or stitching may detach from the mask.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in …
Warning that thermal cameras and other such “temperature screening” products, some of which make direct claims to screen for COVID-19, are not a reliable way to detect if people have the virus.
Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 2020
We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.
Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 2020
The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19
Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the affected batches below contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instr…
Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket.
List of manufacturers and their medical devices which have been granted an exemption by the MHRA
How to get fast-track approval of medical devices during COVID-19.
Find drug safety updates issued by MHRA
Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion so…
Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta).
A new campaign to raise awareness of the fire risk and the precautions that need to be taken by users of skin creams has been launched today
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