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UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
Decentralised Manufacturing Master File (DMMF) template to be completed for a product specific DMMF document.
Managing waste, health and safety, regulations
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
What you need to do if you manufacture or import tobacco products in the UK.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Foresight project looking at the long-term picture for the UK manufacturing sector between now and 2050.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
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