By law, all medicinal product packages in Denmark must bear a product number. The product number is used to identify the individual medicine package (product name, form, strength and pack size).
Product numbers promote the safe handling of medicines by pharmaceutical companies, wholesalers, pharmacists and healthcare staff, etc., but they also ensure the generation of reliable drug statistics.
The marketing authorisation holder or a representative can order a product number (Vnr.) for a medicinal product from Danish Drug Information once the product has been granted a marketing authorisation. It is Danish Drug Information that administers the scheme.
An issued product number must only be used for one marketing authorisation number.
New product numbers for already marketed packages
Marketed packages must receive a new product number if certain changes (variations) are affected for the concerned medicine. Consequently, a new product number must be ordered when at least one of the below conditions are met:
- The name of the medicine changes,
- The marketing authorisation holder changes name or the marketing authorisation is transferred to another company, unless this company belongs to the same group and the name of the medicinal product and the name of the marketing authorisation holder remain the same.
If the change of the name of the marketing authorisation holder only involves a change in the company’s corporate form, e.g. if the name of a company is changed from A A/S to A AB, there is no requirement for a new product number.
Medicinal product packages that have been given a product number but have never been placed on the market, can, however, keep their assigned product number even though the above-mentioned changes take place.
When a medicinal product package is allocated a new product number, all packages bearing the previous product number must be withdrawn from the market. This must take place no later than when the packages with the new product number are placed on the market.
When packages with previous product numbers are withdrawn from the market, the Danish Health and Medicines Authority must be advised by email on rapidalert@dkma.dk.
