Norway

Norway regulates pharmaceutical products through the Norwegian Medical Products Agency — Direktoratet for medisinske produkter (DMP), known as Statens legemiddelverk (NoMA / SLV) until 1 January 2024 when it was reorganised and renamed. DMP operates under the Medicines Act (Legemiddelloven) and aligns with EU pharmaceutical legislation through the European Economic Area (EEA) Agreement, with Norway participating in the EMA Centralised, Decentralised, Mutual Recognition and National procedures, in CMDh, in PRAC and (since 2018) in EMA's scientific committees as a non-voting EEA member. Norway is a full member of PIC/S, the Heads of Medicines Agencies (HMA) and EU pharmacovigilance networks (EudraVigilance, EU SRS). EMA centralised authorisations are valid in Norway via national mirror decisions issued by DMP within ~30 days of EMA opinion. Decentralised, MRP and national applications are routinely handled by DMP. The dossier follows EU eCTD; English is the working language for scientific assessment. Public-sector access runs through Helfo (Helseøkonomiforvaltningen) for outpatient blue-prescription reimbursement (Blåresept) and through the four Regional Health Authorities (Helse Sør-Øst, Helse Vest, Helse Midt-Norge, Helse Nord) for hospital medicines via the Nye Metoder (New Methods) HTA system, with HTA assessments delivered by DMP for single-technology assessments and by the Norwegian Institute of Public Health (FHI) for multi-technology assessments. Pricing for prescription medicines is regulated by DMP using international reference pricing across nine European countries.