Application for extended storage period in connection with dose dispensing
The Danish executive order no. 1654 of 18. December 2018 stipulates that: “The expiry date on the dose container must not exceed 6 weeks from the time when the medicinal products are removed from the original packaging, unless the Danish Medicines Agency, 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.”
Marketing authorisation holders of medicinal products can submit a variation application type IB, no. B.II.f.1.b.2, in case their drug product has not been authorised a storage period outside original packaging in relation to dose dispensing. However, it should be showed that the medicinal product is not moisture or light sensitive cf. the below mentioned requirements:
- Stability data on two batches of the medicinal product for the entire storage period applied for 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 should be provided to show that the medicinal product is not moisture sensitive. The study should simulate a worst-case scenario.
- Photostability study should be conducted according to ICH Q1B and photostability data should show that the medicinal product is not photosensitive outside original packaging.
- 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 include tests of mechanical properties (for automated dose dispensing) and divisibility in case of tablets with a score-line.
Dose dispensing for storage periods longer than 6 weeks:
In connection with automated dose dispensing of medicinal products at Danish pharmacies, it has proven problematic due to discarding that the storage period is only 6 weeks outside the original packaging.
Therefore, the Danish Medicines Agency recommends marketing authorisation holders to apply for approval of an extended storage period longer than 6 weeks for their products. 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.b.2 together with the documentation mentioned above.
Dose dispensing ("brytningstillstånd") in Sweden:
The Danish Medicines Agency is familiar with the list of approved storage periods for medicinal products in connection with dose dispensing ("brytningstillstånd") published by the Medical Products Agency in Sweden. Based on the principle of mutual recognition, the Danish Medicines Agency intends to approve the same storage period of 6 weeks or longer as approved in Sweden, but in addition to the “brytningstillstånd” the Marketing authorisation holder is required to show that the drug product is not photo sensitive outside original packaging cf. requirement to stability data mentioned above.
The marketing authorisation holder is requested to submit a copy of the Swedish authorisation and certify that the composition and shelf-life specification of the medicinal product are identical in Denmark and Sweden.