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How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How to renew marketing authorisations for products granted through different routes and at different times.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
How to change the ownership from one marketing authorisation (MA) holder to another.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
Guidelines to help mitigate and manage medicine shortages.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
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鈥�
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
How to apply for marketing authorisation via this new procedure.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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