New article numbers for already marketed packages
Marketed packages must receive a new Nordic article number if:
- The name of the medicine changes
New rules governing medicine packages
On 25 June 2016, the Danish Medicines Agency issued a new guideline on variations to marketing authorisations for medicinal products and a new executive order on product numbers for medicinal products. They replace guideline no. 126 of 16 December 2009 on variations to marketing authorisations for medicinal products and executive order no. 943 of 22 August 2011 on product numbers for medicinal products.
With the new guideline, the Danish Medicines Agency will ease the administrative and financial bur-den of implementing certain administrative variations. For example, if the marketing authorisation changes ownership or other changes are made to the company information. In future, the implementation process will provide greater flexibility combined with a relaxation of the product number requirement, which will facilitate the introduction of new (changed) medicine packages and reduce medicine wastage and supply issues.
The new rules will make it possible to have two versions of a medicine package in the market at the same time during an implementation period of a maximum of two years. Ahead of this, there will be a period of up to one year from the authorisation of the variation during which the marketing authorisation holder can prepare the implementation of the variation. This means that when the marketing authorisation of a medicinal product changes ownership – and if the medicinal product name is not changed simultaneously – it will be possible to have the old as well as the new packages in the market in Denmark at the same time. Moreover, the packages can have the same product number.