Area of responsibility: Reliable Supply

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