In connection with automated dose dispensing of medicinal products at Danish pharmacies, it has proven problematic that the storage period is only 4 weeks outside the original packaging.
In the Danish executive order no. 80 of 5 February 2003 stipulates that: "The expiry date on the dose container must not exceed 4 weeks from the time when the medicinal products are removed from the original packaging, unless the Danish Medicines Agency (now the Danish Health and Medicines Authority), upon an application from the marketing authorisation holder of the individual medicinal products, has authorised an extended storage period for dose dispensing for all of the medicinal products in the dose container."
In this connection, the Danish Health and Medicines Authority recommends marketing authorisation holders to apply for approval of an extended storage period for their products.
The Swedish Medical Products Agency has a list of approved extended storage periods for medicinal products in connection with dose dispensing ("brytningstillstånd"). Based on the principle of mutual recognition, the Danish Health and Medicines Authority approves the same extended storage periods as they have in Sweden.
For marketing authorisation holders of medicinal products that have been granted extended storage periods longer than 4 weeks in Sweden, it is sufficient to submit a copy of the Swedish authorisation. At the same time, the marketing authorisation holder must certify that the composition and shelf-life specification of the medicinal product are identical in Denmark and Sweden. The application for an extended storage period outside the original packaging must be submitted as a variation application type IB, no. B.II.f.1.b2.
Marketing authorisation holders of medicinal products that have not obtained an extended storage period outside the original packaging longer than 4 weeks, because they have not applied for it, can submit a variation application type IB, no. B.II.f.1.b2, together with the following documentation:
- The currently approved shelf-life specification and stability data on two batches of the medicinal product for the entire storage period applied for stored under the conditions specified below.
- The storage conditions must simulate a worst-case scenario in which the medicinal product is stored outside the original packaging at 25°C/60 % RH in a single layer in a petri dish or something similar that does not provide any protection against light or moisture. It is expected that the stability-indicating parameters tested in normal stability studies are also tested in connection with an application for extended storage outside the original packaging. The application should also include tests of mechanical properties (for automated dose dispensing) and divisibility in case of tablets with a scoreline.
