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Submissions related to human medicines need to be submitted directly to the MHRA.
Find a supplier who can provide a specialist, such as a data scientist or developer, for a specific piece of work.
How the MHRA processes variations to Marketing Authorisations (MAs)
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Marketing authorisations granted in 2024
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.
Marketing authorisations (MAs) granted since January 2014.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to write requirements for services on the Digital Outcomes and Specialists framework
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The Panel of Technical Experts (PTE) is an advisory group of independent consultants who were appointed by government to perform a specific and technical function as part of the first Electricity Market Reform delivery plan process.
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.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Service for Marketing Authorisation Holders, Manufacturers and Wholesalers.
Marking, labelling and marketing standards you must follow to import and export plant seeds, food and manufactured goods.
Pharmacovigilance system requirements
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
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