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Medicines, medical devices and blood regulation and safety

Medicines, medical devices and blood regulation and safety Marketing authorisations, variations and licensing guidance

From:: Medicines and Healthcare products Regulatory Agency

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New applications

Decide if your product is a medicine or a medical device
Apply for a licence to market a medicine in the UK
Medicines: apply for a parallel import licence
Apply for the early access to medicines scheme (EAMS)
Supply unlicensed medicinal products (specials)
Advanced therapy medicinal products: regulation and licensing

Post-licensing

Medicines marketing authorisation: change of ownership
Medicines: apply for a variation to your marketing authorisation
Renew: marketing authorisation for a human medicine
Cancel a medicine's marketing authorisation or other licence
Patient group directions (PGDs)
Periodic benefit risk evaluation reports for medicinal products
Sunset clause: request for public health exemption

Advertising and product information

How to advertise and promote medicines
Blue Guide: advertising and promoting medicines
Advertising investigations by MHRA
How to reclassify your medicine
Medicines: packaging, labelling and patient information leaflets

Other

Medicines: get scientific advice from MHRA
Legal requirements for children's medicines
Medicines: licensing time-based performance measures
Marketing authorisations: lists of granted licences
Parallel import licences: lists of approved products

Payment, fees and applying

MHRA Portal: register to submit forms
How to use RamaXL
Make a payment to MHRA
MHRA fees

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