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Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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 manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Supplementary information on 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.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
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
AI Airlock programme develops industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
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