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Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Detailed guidance on advertising and promoting medicines.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
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 the MHRA processes variations to marketing authorisations.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
How to make a payment to MHRA by credit or debit card or a bank transfer.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
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)’
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Keep up to date with the latest information from the UK GLP monitoring authority.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
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