Manufacturing authorisation
- Published: December 9, 2020
- Last updated: December 9, 2020
All manufacturers of medicinal products in Sweden must have an authorisation for manufacturing and import (MIA). You can apply to the Swedish MPA to obtain an authorisation to manufacture medicinal products. We issue various types of authorisations and also certificates for GMP compliance, known as ‘GMP certificates’.
The common feature of all operators involved in the manufacture of medicinal products is that they have an authorisation (MIA) or hold a GMP certificate or supply another operator which has authorisation or holds a certificate. ‘GMP’ is an abbreviation for Good Manufacturing Practice, the regulatory framework which must be followed in manufacturing.
The manufacturing of medicinal products includes manufacturing, packaging or repackaging.
The Swedish MPA issues a range of authorisations and certificates to operators involved in, for instance, the manufacture of compounding medications, the handling of tissues and cells, blood establishments which produce blood plasma, automated dose dispensing and quality control laboratories.
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Department of Drug Inspectorate – Industry and Hospital
Telephone: +46 (0)18-17 46 00
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