Certificates for the manufacture of active substances
- Published: December 9, 2020
- Last updated: December 9, 2020
Manufacturers of active substances for medicinal products must comply with the GMP requirements. Manufacture must be carried out by the manufacturer and in accordance with the process, and must comply with the specification set out in the authorisation for the finished medicinal product.
Notification
In order to manufacture active substances for human medicines, manufacturers must notify their operations to the Swedish MPA. An update to the information contained in the notification must then be submitted annually.
Inspection
When the Swedish MPA receives a notification concerning the manufacture of an active substance, it will normally carry out an inspection of the operation.
The manufacturer of the active substance may also apply for a GMP certificate. In order to be able to sign the certificate, the Swedish MPA will inspect the operation.
Regulations
In Swedish
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Department of Drug Inspectorate – Industry and Hospital
Telephone: +46 (0)18-17 46 00
E-mail: registrator@lakemedelsverket.se