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If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
Apply for an authorisation to manufacture authorised veterinary medicines and 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.
The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Find out which gas appliances must comply with the Gas Appliances (Safety) Regulations 1995, exemption and penalties for non-compliance
Forms to make a variation to a manufacturer's licence.
Apply to manufacture Extemporaneous preparations, Autogenous vaccines, authorisations for Equine Stem Cell Centre (ESCCA) or Non-Food Animal Blood Bank (NFABBA).
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
List of sites granted a manufacturer or wholesale dealer licence
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Register as a manufacturer, importer or distributor of active substances.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
To apply for a manufacturer licence, complete the appropriate form. Applications for a manufacturer licence will be payable on invoice.
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