Marketing authorisation holders (MAH) can apply for a separate authorisation for a dose-dispensing pack size. The term dose-dispensing package is used to describe a pack size for a medicinal product separately approved for dose-dispensing, which is used when dispensing medicines as single doses for individual patients for a specified treatment period. Medicines that have been granted marketing authorisation through the national, mutual recognition and centralised procedures can apply for an authorisation for a dose-dispensing pack size under the Type IB variation procedure.

Fimea's administrative regulation 1/2009, Applying for and maintaining a marketing authorisation and registration for a medicinal product, has been amended with administrative regulation 4/2011, designed to provide guidance on the procedure to apply for dose-dispensing packages. Administrative regulation 4/2011 entered into force on 14 October 2011.

Applying for a dose-dispensing package

Marketing authorisations for dose-dispensing pack sizes are granted under the standard variation procedure. Regardless of the procedure used for the initial marketing authorisation (i.e. national, mutual recognition or centralised) the variation is always granted under the national procedure. Applicants should use a Type IB, B.II.e.5.z, variation application. The procedure and fees are in line with other national Type IB variations.

Please include the following in your application:

  • A cover letter detailing the scope of the variation.
  • Details of the applied product’s shelf-life once removed from its packaging.
  • Approved product specifications.
  • Confirmation that the same material is to be used for the new pack size as is used for the existing packaging.

The results of stability studies must be provided where the product has been stored outside its original packaging (25°C, 60% relative humidity). The results must cover the shelf-life specified in the application. A report on the product's photosensitivity must also be provided. Conclusions on the stability studies are also required.

Mock-ups for the labelling information must also be provided. The labelling information must state that the pack size is intended for dose-dispensing only. No changes to the summary of product characteristics (SPC) or package leaflet are permitted under the variation procedure.

An application for a dose-dispensing pack size can also be submitted in conjunction with an application for marketing authorisation under the national phase without a separate variation application being required.

Automated dose-dispensing:

When designing the new dose-dispensing package, prospective applicants are asked to note that some medicines may be unsuitable for automated dose-dispensing, for example chemotherapy agents and antibiotics. Please also bear in mind that the product must be mechanically sufficiently durable.

Approved dose-dispensing packages

Fimea publishes a list of all approved applications on its website, including details of the dose- dispensing pack sizes and indicative shelf-life outside the original packaging (below 25oC).

Further information