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Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Notification form to confirm the import is requested by a doctor or dentist and is for use by their patients on their direct responsibility.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
The government's summary of an EU Commission proposal to amend EU legislation relating to medicinal products for human use and the impact on Northern Ireland.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
A list of authorised orphan medicinal products registered by the UK Licensing Authority.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
The way you apply to licence biological products has changed
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