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Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
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)
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
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.
Links to EU guidance, as it stood immediately before end of transition period.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Information for retailers from Great Britain supplying medical devices to Northern Ireland.
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
Industry must notify the MHRA if they will not be using these flexibilities
Supplementary information for international regulators on packaging changes and the export of UK medicines.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
A letter providing guidance on the post-transition conversion process was sent by email on 23 October 2020 to the Community MA holders.
Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
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