Category Archives: Blue Box requirements

New Blue Box requirements published in August 2014

The  CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human)  has published a document about the new requirements concerning the additional information that might be required nationally. For Finland (Finnish and Swedish) the requirements are listed on pages 18 and 19 of this document. There are phrases that one must use.

The requirements are explained briefly in Finnish on the Fimea site. The blue box requirements for Finland are the following:

– ohjeistus yliannostuksen varalta (lisättävä aina) / overdosing (has to be included)

– muut kuin pakkauksessa mainitut käyttötarkoitukset (valinnainen) / to treat other illnesses (can be added if relevant)

– vaikutukset ajokykyyn (valinnainen) / driving ability (can be added if relevant).