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News stories, speeches, letters and notices
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.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
How to renew marketing authorisations for products granted through different routes and at different times.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guidelines to help mitigate and manage medicine shortages.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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…
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
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.
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.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Information about how approved bodies help regulate medical devices and how to apply for approval.
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