The area has four main themes:

Quality

  • To untangle/unravel the quality of chemical and biological medicines including drugs
    Follow up on MA-holders responsibility
  • Conduct classification and administer regulations as relates to narcotics and doping

Laboratory work

  • Control analyses of pharmaceuticals, both from the national market and the European market
  • Represent Norway in the European pharmacopoeia and publish Norwegian pharmaceutical standards
  • Official control authority batch release (OCABR) for vaccines

Marketing interruption

  • Prevent medical product shortages and coordinate measures as regards to instances of acute shortages

Inspections and licences

  • Supervision of all players in the supply chain
  • Handling of quality deficiencies
  • Provide licences and certificates in relation to pharmacy operations, manufacturing process, import, and wholesale businesses.

The area has four units.


Oppdatert: 10.05.2017

Publisert: 17.01.2017