Clarification of labelling practice for warning statements on human medicines

During our review of applications for marketing authorisations for human medicines and variations to marketing authorisations, we have noted uncertainty about the labelling practice regarding the warning statements of schedule 2 of the Danish executive order on labelling. The question is whether these warnings are required on the packaging and in the package leaflet if the warning statements are not supported by the summary of product characteristics (SPC) of the medicinal product concerned.

We therefore find it necessary to clarify the labelling practice for warning statements on human medicines.

Labelling practice for warning statements on human medicines

Schedule 2 of the Danish executive order on labelling lists the warning statements relating to the use of medicines that must be applied to the packaging and included in the package leaflets of human medicines. In addition, the executive order on labelling generally stipulates that all labelling information and the package leaflet must be consistent with the authorised SPC of the medicine concerned.

We wish to clarify that the warning statements provided in schedule 2 of the executive order on labelling are only required on the packaging and in the package leaflet if the specific warning statements of the schedule are supported by information in the relevant medicine’s SPC.

When assessing new applications for marketing authorisations and variations for human medicines, the Danish Medicines Agency will only require that the warning statements of schedule 2 of the executive order on labelling appear from the packaging and package leaflet if the warning is supported by information in the SPC of the medicine concerned.

Medicinal products on the Danish market

This clarification of practice may imply that a revision of the packaging and package leaflet is needed for medicines already marketed in Denmark. This can take place in connection with the next reprint of packaging material and package leaflet.

Warning on analgesics (painkillers)

The Danish Medicines Agency will still generally require that the special warning statements in relation to overdose and storage at home for painkillers containing paracetamol and acetylsalicylic acid (warnings 1 and 2 of schedule 2) appear from the packaging and package leaflet. 

The clarification of labelling practice will be reflected in the Danish Medicines Agency’s Guideline on the executive order on the labelling etc. of medicinal products (in Danish only) at the next revision.