Whom to contact regarding regulatory questions?
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.
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 email@example.com.
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 firstname.lastname@example.org
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 email@example.com
Other general inquiries
For other general inquiries not fitting any of the categories listed above, please use the Email address firstname.lastname@example.org.