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What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to get access to MHRA submissions portals, how to use them, where to go for help.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How the MHRA processes variations to marketing authorisations.
How to use the procedure for medicines licensing applications.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Information on comparator products used in studies supporting abridged marketing authorisation application.
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.
How to renew marketing authorisations for products granted through different routes and at different times.
This guidance summarises our approach to pharmacovigilance
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Approved countries for batch testing and importation of 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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