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Approved countries for batch testing and importation of medicines
Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
Information and recommendations for manufacturers on the preparation and presentation of a post-market surveillance report (PMSR).
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Requirements for sponsor representatives using EHR (electronic health records) in clinical trials.
Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 regulations.
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Meningitis is a serious infection that can develop quickly and affect people of all ages
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Information on practical arrangements for notification, what should and should not be classified as a “serious breach” and what must be reported.
A 5-year deal setting out how community pharmacy will support delivery of the NHS Long Term Plan.
A proposed format to help prepare responses to good distribution practice (GDP)/good manufacturing practice (GMP) post inspection letters.
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.
Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
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