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Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
A clampdown on fake reviews and hidden fees has been announced by the Government which will help customers cut the costs of living.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
The guide, toolkit and further information for GB authorities with responsibility for consumer product safety.
How to use a quasi-experimental study to evaluate your digital health product.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or...
The Rapid Review Panel (RRP) assesses innovative infection prevention and control products, equipment and materials for potential use in the NHS.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
Resources to help anyone developing or running a digital health product to conduct an evaluation.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
The process for the simultaneous review of veterinary drug submissions by Health Canada’s Veterinary Drugs Directorate and the UK's Veterinary Medicines Directorate.
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