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Medicines and Healthcare products Regulatory Agency (MHRA)

  1. Medicines and Healthcare products Regulatory Agency

    The home of Medicines and Healthcare products Regulatory Agency on GOV.UK.

  2. Regulatory status of equipment being used to help prevent coronavirus (COVID-19)

    There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)

  3. Alerts and recalls for drugs and medical devices

    Find alerts and recalls issued by MHRA

  4. Masks: type IIR from Cardinal Health – destroy affected lots (MDA/2020/021)

    Foam strip on the mask can flake and enter the wearer’s airway or mouth; ties and/or stitching may detach from the mask.

  5. How tests and testing kits for coronavirus (COVID-19) work

    The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.

  6. Find product information about medicines

    Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).

  7. Class 4 Medicines Defect Information: Aspar Pharmaceuticals Limited, Ibuprofen 200mg and 400mg tablets packaged in various liveries, EL (20)A/30

    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 …

  8. Don’t rely on temperature screening products for detection of coronavirus (COVID-19), says MHRA

    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.

  9. Field Safety Notices - 13 July to 17 July 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 2020

  10. MHRA guidance on coronavirus (COVID-19)

    We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.

  11. Field Safety Notices - 20 July - 24 July 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 2020

  12. Clinical trials applications for Coronavirus (COVID-19)

    The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19

  13. Class 4 Medicines Defect Information: Ennogen Pharma Limited, Trimogal 100mg and 200mg Tablets, EL (20)A/31

    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…

  14. Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34

    Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket.

  15. Medical devices given exceptional use authorisations during the COVID-19 pandemic

    List of manufacturers and their medical devices which have been granted an exemption by the MHRA

  16. Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak

    How to get fast-track approval of medical devices during COVID-19.

  17. Drug Safety Update

    Find drug safety updates issued by MHRA

  18. Class 4 Medicines Defect Information: Pfizer Limited, Ecalta 100mg powder for concentrate for solution for infusion, EL (20)A/32

    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…

  19. Class 3 Medicines Recall: Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial), EL (20)A/33

    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).

  20. Skin creams dried on fabric can lead to fire deaths

    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