Compassionate use, named patient | https://legemiddelverket.no/english/import-wholesaling-and-retailing/compassionate-use-named-patient-norwegian-godkjenningsfritak | Compassionate use, named patient | In order to use medicines without Market Authorisation (MA) in Norway (or medicines that are not marketed in Norway), prescribers have to apply for compassionate use, named patient (in Norwegian: Godkjenningsfritak). | 1720 | |
Dispensing regulations (utleveringsbestemmelser) | https://legemiddelverket.no/english/import-wholesaling-and-retailing/dispensing-regulations-utleveringsbestemmelser | Dispensing regulations (utleveringsbestemmelser) | NOMA may determine that a drug will be subject to dispensing regulation (1). The pharmacy has a duty to ensure that the requirements for dispensing are met for these medicinal products (2). | 421 | NOMA may determine that a drug will be subject to dispensing regulation. The pharmacy has a duty to ensure that the requirements for dispensing are met for these medicinal products. |
Import of medicinal products for clinical studies in Norway | https://legemiddelverket.no/english/import-wholesaling-and-retailing/import-of-medicinal-products-for-clinical-studies-in-norway | Import of medicinal products for clinical studies in Norway | General guideline regarding persission to import medicinal products for clinical studies in Norway. The guideline also covers the permission to export such products. | 1498 | |
Importing medicines for personal use | https://legemiddelverket.no/english/import-wholesaling-and-retailing/importing-medicines-for-personal-use | Importing medicines for personal use | Bringing medicines into Norway or getting medicines sent by mail is considered importing. | 1616 | |
Procedure for release of blood products and vaccines to the Norwegian market | https://legemiddelverket.no/english/import-wholesaling-and-retailing/procedure-for-release-of-blood-products-and-vaccines-to-the-norwegian-market | Procedure for release of blood products and vaccines to the Norwegian market | The Norwegian Medicines Agency follows the EC administrative procedure for Official control authority batch release. | 422 | |
WDA Holders within the EU/EEA – requirements for the conduct of wholesaler activities with medicinal products in Norway | https://legemiddelverket.no/import-og-salg/import-og-grossistvirksomhet/grossisttillatelse/wda-holders-within-the-eueea-requirements-for-the-conduct-of-wholesaler-activities-with-medicinal-products-in-norway | WDA Holders within the EU/EEA – requirements for the conduct of wholesaler activities with medicinal products in Norway | Wholesaling of medicinal products in Norway based on a wholesaler distribution authorization (WDA) from another EEA country. | 2097 | |
Wholesaling in Norway based on a relevant authorisation (MIA or WDA) issued within the EU/EEA | https://legemiddelverket.no/english/import-wholesaling-and-retailing/wholesaling-in-norway-for-the-products-and-facilities-covered-by-the-mia | Wholesaling in Norway based on a relevant authorisation (MIA or WDA) issued within the EU/EEA | Holders of a MIA or a WDA issued within the EU/EEA can perform wholesaler activities in Norway for the products and activities covered by the MIA/WDA. NoMA should be notified when such activities are planned. | 1099 | |