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Whom to contact regarding regulatory questions?

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At NoMA the area of "Regulatory affairs and better use of medicines" is responsible for all regulatory affairs before and after a marketing authorization (MA) for a medicinal product has been granted.

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    Within this area of responsibility there are 3 units that are are involved in handling inquires and questions concerning regulatory affairs. 

    ​​​Unit for regulatory affairs before MA and regulatory affairs after MA

    Inquiries concerning coordination of applications (MAs, variations, renewals) when Norway is a Concerned Member State (CMS) in a Decentralised/Mutual Recognition Procedure (DCP/MRP), or when Norway is a Member State (MS) in the Centralised Procedure CP) should be sent to mt@noma.no.

    Inquiries concerning coordination of applications (MAs, variations, renewals) when Norway is a Reference Member State (RMS) in DCP/MRP, or when Norway is a Rapporteur/Co-rapporteur in CP. Also inquiries concerning national applications (MAAs, variations, renewals) and radiopharmaceuticals should be sent to mt@noma.no

    Unit for medicinal product information

    Inquiries concerning approvals of labelling (Summary of Product Characteristics, Package Inserts and labels), national part of application procedures and product withdrawals should be sent to pi@noma.no

    Other general inquiries

    For other general inquiries not fitting any of the categories listed above, please use the Email address post@noma.no.

    Contact us

    Norwegian Medical Products Agency

    (+47) 22 89 77 00

    post@noma.no