descriptive statistics are used to present sales of ANRs in Norway. The ANRs are classified by indication group and assigned a recommended daily dose (RDD) according to the posology section in the Summary of Product Characteristics (SPC). Document analysis of regulation and general information concerning natural remedies is used to compare the authorization schemes for ANRs in Scandinavia and for traditional herbal medicinal products (THMs) in the EU. Four cases of herbs are described to illustrate the consequences of this regulation and identify possible influencing factors.
Main outcome measure
sales, in terms of both mean consumer prices and number of RDDs, and the factors found to influence the number of marketed ANRs.
total sales of ANRs in Norway in 2003 were € 1.5 per capita (3% of the food supplement market), or 5.5 RDD/1,000/day, and the sales have tended to decline. Norway has very few ANRs compared with Sweden and Denmark. Changes in Norwegian ANR regulation in 2004 have harmonized application requirements in Scandinavia, but results have yet to be seen. THMs are subject to the same quality requirements as ANRs, and will replace the ANRs over the next 7 years. Several factors have influenced the manufacturers’ application incentive, e.g., application costs, differentiated VAT rates, consumer knowledge and surveillance by health authorities.
sales of authorized compared to unauthorized natural remedies in Norway are very low and the ANRs are in a weak position compared to Denmark and Sweden. Surveillance by health authorities and increased consumer knowledge of ANRs is probably more stimulating with respect to application incentive than lower application costs. Introducing THMs will hopefully increase the number of quality-controlled products on the Scandinavian market.