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Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
This guidance summarises our approach to pharmacovigilance
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
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.
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
How to use the procedure for medicines licensing applications.
Points to consider when using real-world data in clinical studies
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Information about the MHRA's duties and how you can report a non-compliant medical device.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
How to register as a manufacturer, importer or distributor of active substances.
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