NoMA can impose infringement penalties
The Norwegian Medicines Agency (NoMA) has now the legal basis to impose infringement penalties.
As of 1 January 2022, the Norwegian Medicines Agency (NoMA) has the legal basis to impose infringement penalties. This right applies according to the Medicinal Products Act, the Medicinal Products Regulation, the Pharmacy Act and the Pharmacy Regulation.
The infringement penalties can be imposed in connection with different marketing activities, illegal import, illegal wholesaler activity, illegal retail sales and marketing authorisation requirements.
Link to the guidelines for the infringement penalties (in Norwegian only): Retningslinjer overtredelsesgebyr 170122.pdf (legemiddelverket.no)
Our team are highly qualified and experienced within regulatory affairs, pharmaceutical wholesale and marketing, and are happy to guide you through the applicable national legislation.