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Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Comply with good pharmacovigilance practice and prepare for an inspection.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Keep up to date with the latest information from the UK GLP monitoring authority.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
How to join the phase I accreditation scheme.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.
The MMRV vaccine will become part of the routine childhood immunisation schedule in the UK from 1 January 2026.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
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.
How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.
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