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null Text ‘Itsehoitolääke / Receptfritt läkemedel’ to be added on over-the-counter medicine packages

Text ‘Itsehoitolääke / Receptfritt läkemedel’ to be added on over-the-counter medicine packages

29.8.2018

In the future, the outer packages of medicines subject to marketing authorisation and registered medicines sold without a prescription shall bear a text indicating their general classification for supply as over-the-counter medicines. This labelling text will make it easier to separate medicines from food supplements and medicinal devices which are also sold in pharmacy. At the same time, the labelling of packages will be harmonised with the requirements of the Swedish Medicinal Products Agency.

The requirement will be added to national regulation 3/2013 Labelling and package leaflets for medicinal products. Marketing authorisation and registration holders may implement the change in the package labelling in connection with the next update pertaining to product information.

Ytterligare information ges av

  • Niina Makkonen, Senior Researcher, tel. +358 29 522 3389
  • The e-mail addresses have the form firstname.lastname@fimea.fi