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MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
Guidance on labelling requirements pertinent to the type of medicinal product and its supply status, as defined in UK legislation.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
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)).
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
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