Guidance

List of registered manufacturers and distributors of active substances

Public register of authorised manufacturers, importers and distributors of active substances used in medicines in the UK.

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Content that is already published on the EMA website

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Details

The list is an EU requirement for national competent authorities (in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA)) to publish registered manufacturers, importers and distributors of active substances.

MHRA may conduct inspections against the requirements of the relevant good practices before allowing such businesses to start trading.

MHRA regulates active substances in medicinal products. Falsified active substances and active substances that do not meet legal requirements pose serious risks to public health and should not be made available in the supply of medicines.

See MHRA’s guide for details on how to apply for registration.

Contact

Process licensing (PcL) enquiry line

MHRA

Email pcl@mhra.gov.uk

Telephone: 020 3080 6844

Opening hours: 9:30am to 12:30pm

Users of the PCL Portal for:
• Wholesale Distribution Authorisations
• Active Substance Registrations
• Distance Selling Logo Registrations

For enquiries from manufacturing and wholesale distribution authorisation holders, broker registration and active pharmaceutical ingredient (API) registration holders about their licence/authorisation/registration.

Published 17 March 2014