Sideinnhold
Reliable Supply consists of five units and covers five main areas:
Quality
- Assessment of the quality of chemical and biological medicinal products including
follow up on MA-holders responsibility
Laboratory
- 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
Availability of marketed medicinal products
- Prevent shortages and coordinate measures in case of acute shortages
Inspections and licences
- Inspections related to the supply chain and clinical studies
- Handling of rapid alerts, including quality deficiencies and falsified medicines
- Supervise and provide licenses and certificates in relation to pharmacy operations, manufacturing process, import, and wholesale businesses.
- Classification and narcotics/doping regulations and the regulatory framework guiding international travel with pharmaceutical products
Medical devices
- Supervise manufacturers and notified bodies
- Handle adverse incidents
- Classify medical devices
- Assess applications for clinical investigations