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Apply for an import certificate to import a medicinal product into the UK for veterinary use.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How to change the ownership from one marketing authorisation (MA) holder to another.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance on Animal Test Certificates (ATCs) required to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Registers of authorised manufacturers, wholesale dealer sites and retailers.
The actions to take for sourcing medicines in different circumstances.
Approved countries for batch testing and importation of medicines
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
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