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Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
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