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Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
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.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
How to use RamaXL, including system availability, running reports and how to subscribe.
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.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
Industry must notify the MHRA if they will not be using these flexibilities
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Supplementary information for international regulators on packaging changes and the export of UK medicines.
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