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Register to vote Register by 18 June to vote in the General Election on 4 July.
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.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Keep up to date with the latest information from the UK GLP monitoring authority.
This guidance summarises our approach to pharmacovigilance
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
How to change the ownership from one marketing authorisation (MA) holder to another.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Submission dates and how the submissions using the EC decision reliance procedure work.
Advice on writing clear notices and maximising replies to your FSNs.
Links to EU guidance, as it stood immediately before end of transition period.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
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