In June 2010, the Danish Medicines Agency announced that packs of medicine are required to have the medicine's name and strength printed in Braille writing (raised dots) on the outer packaging no later than 30 October 2010 (expiry of the 5-year transition period) when the medicine is supplied to a wholesaler.
See the link to the executive order on labelling for further details on this requirement (in Danish only).
The Danish Medicines Agency has carried out spot checks to follow up on the implementation of the requirement on Braille writing.
10 in 518 packs were deficient
518 packs of medicine have been controlled for the presence of raised dots. Of these, 10 packs from 10 different marketing authorisation holders did not have the required raised dots. In addition, one pack had illegible raised dots.
As a result of the Danish Medicines Agency's enquiry, five of the marketing authorisation holders discovered a further 45 packs in their ranges, which did not have any raised dots.
The packs have now been recalled at wholesale level, and the marketing authorisation holders have been ordered to find measures to implement raised dots as quickly as possible.
