Opening permission for automated dose dispensing

Prior to automated dose dispensing, the packages for the medicinal products need to be opened/broken in order to dispense the tablets and/or capsules into a container/pouch.

The application for an opening permission for automated dose dispensing

The application should comprise the following:

• a cover letter clearly stating that it is an application for

  • an opening permission for automated dose dispensing or

  • an extended shelf life outside of the original packaging for a medicinal product with a previously granted opening permission for automated dose dispensing. 

• A proposed shelf life outside of the original packaging. The shelf life can be maximum six months.

• The current product specification for the medicinal product.

• Stability studies for the medicinal product in open storage. The requirements for the scope of the studies depend on previously drawn conclusions regarding the stability of the medicinal product. The studies should include analyses of stability indicating parameters such as degradation products. Data should be supplemented with conclusions from conducted studies.

The application is sent to RIC@läkemedelsverket.se

Requirements for the medicinal products

For automated dose dispensing there are requirements on the mechanical strength and shape for the medicinal product. Certain medicinal products such as cytostatics and some antibiotics are unsuitable for use in dose dispensing equipment due to the risk of cross-contamination.

Usage period

The opening permission contains information on the maximum acceptable shelf life outside the original packaging, including the period for storage in a machine cassette and as a dispensed dose. The usage period shall be based on documentation of shelf life under relevant conditions, such as 25 °C at 60 % relative humidity, up to six months. The period of use shall not exceed the shelf life applicable to the original container.