New rules governing medicine packages
The Danish Medicines Agency has amended the guideline on variations to marketing authorisations and the executive order on product numbers for medicinal products.
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 burden 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 amendments should be of benefit to the companies, but at the same time it has been vital for the Danish Medicines Agency that the amendments do not have an inappropriate impact on patient safety and that medicine consumption in Denmark can also be monitored in future. Simultaneously, the new rules and the new practice will continue to secure and support the practical handling of medicine packages in the supply chain as well as in the health sector,” says Thomas Senderovitz, Director General of the Danish Medicines Agency.
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.
Note that the product number requirement is also eased for multi packages and large packages.
The Danish Medicines Agency has prepared an illustration that provides an overview of the implementation process for the affected administrative variations to marketed medicinal products, because there is a link to the process for the submission of variation applications and the process for notifications to Medicine Prices.