Short survey of Norwegian legislation concerning import, wholesaling and retailing of pharmaceuticals.
1. Import of pharmaceuticals – Norwegian Act on Medicinal Products etc., Clause 14 and 15.
There are two sources of import:
- countries inside in the European Economic Area (EEA)
- countries outside the European Economic Area (EEA)
Those who have an approved wholesalers licence according to the Norwegian Act on Medicinal Products clause 14, have permission to import pharmaceuticals from countries inside EEA.
Import of pharmaceuticals from countries outside EEA requires additional special licence from Norwegian Medicines Agency.
Exception from the above regulations: Pharmaceutical manufacturers approved according to the Norwegian Act on Medicinal Products clause 12 , may import raw materials necessary for manufacturing of the products included in the approved manufacturing licence.
2. Wholesalers – Norwegian Act on Medicinal Products etc., Clause 14 and 15.
Wholesaling is defined as all activities necessary for procurement, warehousing, distribution and export of pharmaceuticals with the exception of distribution to the public. Wholesaler is legally defined as a person or a company who carries out wholesaling business.
To carry out a wholesaling business the person or the company must obtain approval from Norwegian Medicines Agency. This is according to the Norwegian Act on Medicinal Products, clause 14 and Regulations on Wholesaling Business, clause 2.
Exception from the above regulations: Pharmaceutical manufacturers approved according to the Norwegian Act on Medicinal Products clause 12 and importers according to clause 13. do not need special approval to carry out wholesaling. Such manufacturers and importers holding licences of manufacturing and importing may carry out wholesaling. . However the wholesaling activity must be limited to the products that are already included in their manufacturing or importing licences.
Companies holding manufacturers licences for products in a country inside the EEA, may also engage themselves in wholesaling activities limited to the products that are included in the manufacturers licence. This is according to current Regulation on pharmaceutical wholesaling, clause 3.
Wholesalers can only purchase pharmaceuticals from other approved wholesalers or from manufacturers and importers holding wholesaler licence according to the Norwegian Act on Medicinal Products, clause 14.
Wholesalers can only deliver pharmaceuticals to other approved wholesalers, approved manufacturers (Medicines Act, clause 12) or importers (Medicinal Act clause 13 or to retailers according to clause 16.
Wholesalers supplying pharmacies are according to the Regulation on Wholesalers obliged to carry out certain public services. These obligations are listed in chapter III in the Regulation on Wholesalers. Important obligations are for instance that the wholesalers must carry a sortiment of products in demand in the Norwegian market and that they must be able to satisfy delivery anywhere in Norway within 24 hours (clause 4).
According to the Regulation on wholesalers a wholesaler should supply the National Health institute with detailed sales figures. According to Chapter VI in the Wholesaler Regulation the wholesaler are obliged to pay a fixed percentage of their sales to The Norwegian Medicines Agency.
3. Retail business - Norwegian Act on Medicines Products, clause 16.
Retailing is defined as distribution and sales of pharmaceuticals to the public, included health institutions or other end users of pharmaceuticals.
The Act on Pharmacies, clause 1-4 states that pharmacy business requires two licences for each pharmacy. First a licence to own a pharmacy (proprietors licence) and then a licence to run the pharmacy (operating licence).
Only pharmacies or medicinal outlets (controlled by pharmacies) may carry out retailing of pharmaceutical products. Regulations may make exceptions for pharmaceuticals intended for technical or scientific or other non-medicinal use. As an exception manufacturers or non-pharmaceutical retailers may sell pharmaceuticals for such non-medicinal use. Regulations may also make exception for certain non-prescription pharmaceuticals to be sold by other retailers than pharmacies.
Other exceptions: According to the Medicinal Act, clause 15 the Department of Health may give Regulations permitting wholesalers to deliver pharmaceuticals directly to professional end users such as hospitals, physicians, dentists, official and officially approved health institutions, laboratories, scientific institutions and the like. The Department of Health may also give Regulations granting approved wholesalers permit to deliver medicines for veterinary use directly to professional end users.
Sist gjennomgått: 13.09.2005
Første gang publisert: 02.12.2003