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Register to vote Register by 18 June to vote in the General Election on 4 July.
How investigators and sponsors should manage clinical trials during COVID-19
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
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.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
The actions to take for sourcing medicines in different circumstances.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to change the ownership from one marketing authorisation (MA) holder to another.
Registers of authorised manufacturers, wholesale dealer sites and retailers.
Requirements for an Animal Test Certificate (ATC) to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
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.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Who in the pharmaceutical industry can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
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