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Submissions related to human medicines need to be submitted directly to the MHRA.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How the MHRA processes variations to Marketing Authorisations (MAs)
Find out what makes a person an enabler of tax avoidance, and what to do about legally privileged communications.
Guidance about working in collaboration with other charities.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
Find out how the scheme works, including issuing shares and raising money, and how to submit your compliance statement.
The way you apply to licence biological products has changed
Guidance on third party access to Business Gateway
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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.
The European Union (EU) and European Economic Area (EEA) - which countries are in the EU and EEA, the single market and free movement of goods, capital, services and people
Growth Hubs are local public/private sector partnerships led by the Local Enterprise Partnerships (LEPs). They join up national and local business support so it is easy for businesses to find the help they need.
Find out about gaining approval for a fair partial exemption special method if you deal with partial exemption for insurers.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Guidance for the pharmaceutical industry on applying for a marketing authorisation for parallel import (MAPI).
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
How to change the ownership from one marketing authorisation (MA) holder to another.
Don’t include personal or financial information like your National Insurance number or credit card details.
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