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This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
MHRA invites current and former suppliers to join Risk Ledger and complete a security profile to strengthen supply chain cyber security.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
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)’
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Keep up to date with the latest information from the UK GLP monitoring authority.
Detailed guidance on advertising and promoting medicines.
Guidance on the deadlines for initial and response submissions.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
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…
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
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