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What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Find out which standards and regulations apply to your product and how to make sure you follow the right procedures.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Guidance for manufacturers, importers and distributors.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
How product specific rules are used to identify the country of origin when importing or exporting between the UK and EU.
Information on trade sanctions, arms embargoes and trade restrictions, including trade controls, transit controls and restrictions on terrorist organisations.
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