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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.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Information on comparator products used in studies supporting abridged marketing authorisation application.
How the MHRA processes variations to marketing authorisations.
How to use the procedure for medicines licensing applications.
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)’
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
This guidance summarises our approach to pharmacovigilance
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to renew marketing authorisations for products granted through different routes and at different times.
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.
Approved countries for batch testing and importation of medicines
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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.
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