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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to use the procedure for medicines licensing applications.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
How the MHRA processes variations to Marketing Authorisations (MAs)
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Keep up to date with the latest information from the UK GLP monitoring authority.
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…
Fees payable to the MHRA for 2023 to 2024
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
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.
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
Information about the EU Regulations and their implementation in Northern Ireland
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
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