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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 the MHRA treats traditional herbal medicines and homeopathic medicines.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
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.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Information about how approved bodies help regulate medical devices and how to apply for approval.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.
An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
Information relating to the disapplication of falsified medicines under UK Law.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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