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Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
The government will place 6 new synthetic opioids under the strictest level of control.
Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
Information for patients, healthcare professionals and developers of new medicines
The review of the safety of isotretinoin has concluded.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Regulations to reduce the risk posed by the production, importation and storage of ammonium nitrate.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Jan - 31 Mar 2024.
Fifteen additional synthetic opioids are now under the strictest controls to prevent drug related deaths and ensure anyone caught supplying them faces tough penalties.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification. Doncaster Pharma Limited have identified an error relating to the Braille printed on the...
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
How to prepare for implementation and compliance of the Safety Features Regulation.
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