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Information on comparator products used in studies supporting abridged marketing authorisation application.
How to renew marketing authorisations for products granted through different routes and at different times.
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.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
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.
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 how to complete your Electronic Application Form (eAF) and Cover Letter
Guidelines to help mitigate and manage medicine shortages.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
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…
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
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