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Data, Freedom of Information releases and corporate reports
How to change the ownership from one marketing authorisation (MA) holder to another.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Information about how approved bodies help regulate medical devices and how to apply for approval.
How to renew marketing authorisations for products granted through different routes and at different times.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Guidelines to help mitigate and manage medicine shortages.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
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)
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 on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
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.
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