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New rules on fines for breaches of the Norwegian medicines act and pharmacy act

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On 21 June 2019 the Norwegian government sanctioned new rules on administrative fines for breaches of the Norwegian Medicines Act and Pharmacy Act, that were adopted by the Parliament on 11 June.

The new rules gives the Norwegian Medicines Agency competence to impose fines in the following cases:

  • Operating a pharmacy without license
  • Illegal sales of pharmaceuticals
  • Illegal import of pharmaceuticals
  • Breaches of obligatory notification obligations for market authorization holders

Up until now, The Norwegian Medicines Agency has not had the power to impose fines for breaches of the law. This is now going to change, both due to this decision and through a legislative change in 2018 that introduced a legal basis for imposing fines for breaches of the rules on advertising and keeping records of narcotics. It is not clear when the changes will enter into force.

The fine will be an administrative sanction and subject to the stricter procedural rules in the Public Administration Act.

More information about the decision can be found on the Parliament's homepage (in Norwegian only).

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