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Guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs).
Guidance for medical device manufacturers on when electronic instructions for use can be used.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access p…
How investigators and sponsors should manage clinical trials during COVID-19
The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs)
Report on the public health impact of nurses and midwives, dentists, allied health professionals and pharmacists.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Every year MHRA receives requests for its staff to speak at conferences and other events across the world.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
Under some circumstances (clarified in this statement), the CMA will not prioritise enforcement action against competing drug firms in relation to commercial negotiations to make combination therapies available to patients, …
This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee (KPSC), to summarise known safety issues with dialysis and continuous renal replacement therapy (CRRT) and describe what to do to m…
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
The way you apply to licence biological products has changed
Guidance for specialists for initiation of valproate in female patients and for annual review and pregnancy testing to support adherence to pregnancy prevention requirements during the pandemic.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How to best protect patients and volunteers during magnetic resonance imaging (MRI) examinations.
A 5-year voluntary scheme on the control of prices agreed between government and the Association of the British Pharmaceutical Industry (ABPI).
This guideline is to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
How to get fast-track approval of medical devices during COVID-19.
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