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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
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 to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
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
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidelines to help mitigate and manage medicine shortages.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Information about how approved bodies help regulate medical devices and how to apply for approval.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
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