News on dose dispensing of medicinal products

New Danish executive order

The Danish executive order on dose dispensing of medicinal products has been updated; Executive order no. 1108 of 29 September 2017 on prescriptions and dose dispensing of medicinal products

Based on the update, the storage period is extended from 4 to 6 weeks for medicinal products approved for dose dispensing. Furthermore, it has become a precondition that a medicinal product is included on the Danish Medicines Agency’s list of dose dispensed medicines, in order for the medicinal product to be used for dose dispensing. Previously, the list was only guiding. Due to this change, Sinemet products have been included in the DKMA’s list of dose dispensed medicines with the remark that these medicinal products should be packed separately for dose dispensing. The remark on separate packing, can be found on the webpage by the following link;

Remarks for the Danish Medicines Agency’s list of dose dispensed medicines (Danish)

Requirements for the documentation when applying for a storage period

The information on the Danish Medicines Agency’s webpage ‘Application for extended storage period in connection with dose dispensing’ has been updated to more clearly specify the requirements for the documentation, especially with respect to light sensitivity, when applying for a storage period for dose dispensing. 

Application for a storage period outside original packaging in connection with dose dispensing