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Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Register as a manufacturer, importer or distributor of active substances for use in veterinary medicines.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
Guidance for manufacturers, importers and distributors.
What you need to do to comply with regulations on manufactured goods you place on the Northern Ireland market.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
Registers of authorised manufacturers, wholesale dealer sites and retailers.
Advice on writing clear notices and maximising replies to your FSNs.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
Don’t include personal or financial information like your National Insurance number or credit card details.
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