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How to conform with the legal requirements for placing medical devices on the market.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Guidance on transitional arrangements for the Clinical Trials Regulations
How the MHRA processes variations to marketing authorisations.
Guidance on using non-investigational medicinal products in a clinical trial.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Fees payable to the MHRA from 2025.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
You must get permission to export certain drugs and medicines.
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 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 to change the ownership from one marketing authorisation (MA) holder to another.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
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