Norwegian Medicines Act
E508891
The Norwegian Medicines Act is a key piece of Norwegian legislation that regulates the production, approval, distribution, and use of medicinal products to ensure their quality, safety, and proper control.
Statements (50)
| Predicate | Object |
|---|---|
| instanceOf |
Norwegian law
ⓘ
medicines legislation ⓘ |
| aimsTo |
ensure that benefits of medicines outweigh risks
ⓘ
prevent circulation of falsified medicines ⓘ prevent circulation of substandard medicines ⓘ |
| alignedWith | European Union medicines legislation principles ⓘ |
| appliesTo |
biological medicinal products
ⓘ
human medicinal products ⓘ immunological medicinal products ⓘ medicinal products prepared in pharmacies ⓘ over-the-counter medicines ⓘ prescription-only medicines ⓘ radiopharmaceuticals ⓘ veterinary medicinal products ⓘ |
| country | Norway ⓘ |
| defines |
marketing authorisation
ⓘ
medicinal product ⓘ pharmacy ⓘ wholesale distribution ⓘ |
| enforcedBy | Norwegian Medicines Agency NERFINISHED ⓘ |
| hasPurpose |
ensure proper control of medicinal products
ⓘ
ensure quality of medicinal products ⓘ ensure safety of medicinal products ⓘ promote correct use of medicinal products ⓘ protect public health ⓘ |
| jurisdiction | Kingdom of Norway NERFINISHED ⓘ |
| legalArea |
health law
ⓘ
pharmaceutical law ⓘ |
| regulates |
approval of medicinal products
ⓘ
clinical trials of medicinal products ⓘ distribution of medicinal products ⓘ export of medicinal products ⓘ import of medicinal products ⓘ marketing authorisation holders ⓘ marketing of medicinal products ⓘ medicinal products ⓘ pharmacies ⓘ production of medicinal products ⓘ sale of medicinal products ⓘ use of medicinal products ⓘ wholesalers of medicinal products ⓘ |
| requires |
marketing authorisation before placing medicinal products on the market
ⓘ
pharmacovigilance and safety monitoring of medicinal products ⓘ proper storage and distribution conditions for medicinal products ⓘ |
| subjectOf |
regulations on advertising of medicinal products
ⓘ
regulations on distribution and wholesale of medicinal products ⓘ regulations on labelling of medicinal products ⓘ regulations on marketing authorisation ⓘ regulations on pharmacovigilance ⓘ regulations on pharmacy operations ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.