Temporary repackaging of medicines with a marketing authorisation

Updated 28 September 2023

Occasionally, a marketing authorisation holder (MA holder) will need to repackage a medicinal product for a short temporary period. The Danish Medicines Agency considers that repackaging should generally be carried out by one of the manufacturing sites approved in the marketing authorisation. This should contribute to ensuring a high quality of the repackaging, and the Danish Medicines Agency does not need to be involved.

But sometimes financial and logistical aspects may imply that it is not always possible for the MA holder to use one of the manufacturing sites authorised in the marketing authorisation.

If the marketing authorisation holder (MAH) temporarily needs to repackage medicinal products at a new location, the MAH should submit a variation type IAIN, no. B.II.b.1.a (for medicinal products for human use) or a variation VNRA, nr. B.21 (for medicinal products for veterinary use) under the purely National Procedure. This also applies to medicinal products authorised under MRP and DCP. The assessment time for a temporary repackaging variation is the same as for a type IAIN variation or a type VNRA variation, respectively. Here you find the Variation application forms. You can find further information and guidelines on variation applications here: Application for variations. 

In connection with 'applications for a secondary packaging site', it must be decided whether the secondary packaging site should also be responsible for releasing the medicinal products or whether this should be arranged by the batch release site used so far. If the new secondary packaging site is to release the medicinal products, the package leaflet must be changed. Alternatively, it is necessary to apply separately for exemption from the Danish executive order on labelling etc. of medicinal products (in Danish titled: “mærkningsbekendtgørelsen”).

Regardless of whether it is the batch release site used so far or the secondary packaging site which appears on the package leaflet, GMP agreements must be arranged between the involved Qualified Persons (QP agreements). It is furthermore assumed that technical agreements between the MA holder and the secondary packaging site have been made.

For more information concerning