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Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
This guidance summarises our approach to pharmacovigilance
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
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.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Keep up to date with the latest information from the UK GLP monitoring authority.
Guidance on using non-investigational medicinal products in a clinical trial.
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.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
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