The Norwegian Medicines Agency prepares annual plans for audits of economic operators. The plans are based, among other things, on risk assessment, safety monitoring data, complaints and cooperation with other European authorities.
Inspection of economic operators may be planned or unannounced. The economic operator is then obliged to give the Norwegian Medicines Agency access to, among other things, the premises, warehouse and documentation we ask to see. After an inspection, a report will be prepared. The report contains an overview of the non- compliances from legal and technical requirements in accordance with the regulations for medical devices. The economic operator is given the opportunity to comment on the report before it is finalized (adopted?). In the case of non-compliances, the economic operator must prepare an action plan for how the non-compliances are to be resolved. The Norwegian Medicines Agency may require the economic operator to provide corrective and preventative actions of deficiencies found during audits or inspections.
Some findings and deficiencies can be of such a serious degree that we may decide to make decisions about, for example, a ban on sale, recall and destruction. We can also impose a coercive fine. Cooperating European authorities will be informed of our decisions.
For further details see MDR Article 93-100 and IVDR Article 88-95.
The Norwegian Medicines Agency is subject to the Public Administration Act and you can appeal our decisions.