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Detailed guidance, regulations and rules
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Consultations and strategy
Data, Freedom of Information releases and corporate reports
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
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.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
How to renew marketing authorisations for products granted through different routes and at different times.
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.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidelines to help mitigate and manage medicine shortages.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Information about how approved bodies help regulate medical devices and how to apply for approval.
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