Dmp.no

The Norwegian health care system and pharmaceutical system

WebThe Ministry of Health and Care Services (Helse- og omsorgsdepartementet, HOD) is the legislative authority. The Norwegian Medical Products Agency (Direktoratet …

Actived: 4 days ago

URL: https://www.dmp.no/english/about-us/the-norwegian-health-care-system-and-pharmaceutical-system

Guidance and regulations

WebGuidance and regulations. Published: 13/10/2023. The Norwegian Medical Products Agency is the competent authority for medical devices in Norway. The Agency …

Category: Medical Go Health

The Norwegian Medicines Agency was assigned greater …

WebMedicines and health technology are rapidly developing, and the industry is forward-looking. More products being available improves the quality of people’s lives, …

Category: Medicine Go Health

Scientific and regulatory advice for the development of medical

WebGeneral o bligations for health institutions when using medical devices Cases in which obligations of manufacturers apply to importers, distributors or other …

Category: Medical Go Health

FINOSE collaboration prolonged and strengthened by entry of the …

WebThe members of FINOSE expect the collaboration to continue beyond 2025 with a focus on products not covered by the European collaboration and joint …

Category: Health Go Health

General information about Compassionate use, named patient

WebThe Norwegian Medical Products Agency (NOMA) evaluates applications for named patient use ( the Norwegian Medicinal Products Regulation, sections 2-5, 2-6 and …

Category: Medical Go Health

Our goals and tasks

WebOur goals and tasks. The Mission of The Norwegian Medical Products Agency (Direktoratet for medisinske produkter, NOMA) is to evolve and safeguard public …

Category: Medical Go Health

Clinical Trial Application for GMO Medicinal Products for Humans

WebHealth and Environmental Risk Assessment with conclusions following the requirements in Annex 2 of the EIA-regulations. Documentation and assessment of …

Category: Health Go Health

Unit cost database

WebUnit cost database. This is an overview of unit costs to facilitate the work in health technology assessments (HTAs) and submission of documentation. The unit cost …

Category: Health Go Health

The Norwegian Adverse Drug Reaction Registry

WebPublished: 19/10/2023. The Norwegian Adverse Drug Reaction Registry (the NorADR registry) contains reports of suspected adverse reactions to medicines submitted by …

Category: Medicine Go Health

General o bligations for health institutions when using medical …

WebHealth institutions that sponsor or health professionals who participate in a clinical investigation or performance study, must be aware of their obligations. For further …

Category: Health Go Health

Horizon scanning or request for assessment

WebThe Norwegian Medical Products Agency prepares horizon scanning notifications for all new active ingredients and extensions of therapeutic indications covered by the National …

Category: Medical Go Health

Educational material

WebThe reason for this is that almost all health personnel use Felleskatalogen, and there is a greater probability that educational material will be used if it is easily accessible. It will …

Category: Health Go Health

Electronic cigarettes (e-cigarettes)

WebThe new regulations will impose requirements on the content, quality, safety, and labeling of all e-cigarettes and refill containers (e-liquids, e-juice), both with and …

Category: Health Go Health

EU Declaration of Conformity

WebPublished: 12/10/2023. The declaration of conformity is the manufacturer's written declaration that the device meets the requirements of the regulations that apply to the …

Category: Health Go Health

Collaboration with Nordic Pharmaceutical Forum

WebPoints of contact between FINOSE and New Expensive Drugs (NED) throughout the health technology assessment (HTA) and negotiation processes. [1] …

Category: Health Go Health

Products prioritised in FINOSE

WebMedicinal products that require a cost utility analysis, CUA for the health economic assessment; Medicinal products suitable and of interest for joint Nordic …

Category: Health Go Health