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This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
How to write clear and effective field safety notices (FSNs) for medical devices.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
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.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Keep up to date with the latest information from the UK GLP monitoring authority.
Guidance on transitional arrangements for applying for clinical trial approval.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
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).
Guidance on categorising certain clinical trials as ‘notifiable’.
How the MHRA makes decisions on what is a medicinal product (borderline products).
This guidance summarises our approach to pharmacovigilance
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