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MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
Details of eligibility requirements and the application process for the mainstream scheme, the route through which most people join.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
A Success of Market Liberalism or a Product of a Longer History?
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Decentralised Manufacturing Master File (DMMF) template to be completed for a product specific DMMF document.
How we calculate and allocate revenue funding for mainstream free schools in the 2025 to 2026 academic year.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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