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Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Detailed guidance on advertising and promoting medicines.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
How the MHRA processes variations to marketing authorisations.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
How to make a payment to MHRA by credit or debit card or a bank transfer.
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)’
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Keep up to date with the latest information from the UK GLP monitoring authority.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
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