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Norway: NMA Changes in the Medicines Regulations

Friday, November 17, 2017: The Norwegian Medicines Agency has changes in the medicines regulations and the breach scheme from 1 January 2018. From 1 January 2018, all drugs must meet the criteria for prioritization (utility, resource use and severity) in order to be given a blue prescription. The Danish Medicines Agency shall evaluate (evaluate) all new medicines.

The same prioritization criteria apply to medicines financed by health enterprises.

A drug may only be granted pre-approved reimbursement or individual benefit on blue prescription, if the cost is in a reasonable proportion to the usefulness of the drug assessed against the severity of the condition. At high severity, higher costs are accepted compared to the benefit of the drug than at lower severity.

From the same time, the principle is introduced that the financial responsibility should follow the responsibility for treatment. The changes apply only to benefits for medicines, and not for medical consumables and foodstuffs.

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