Poland transposes EU Braille format requirements for drug packaging
This article was originally published in RAJ Devices
As of 1 November 2008, marketing authorisation holders in Poland will be required to use the Braille format on human drugs packaging. The Polish ministry of health has already started a consultation process on the draft decree introducing the change, which is a result of amendments made in the EU pharmaceutical legislation in 2004. Recently, the ministry also issued a separate decree concerning the labeling of veterinary medicines. To date, packaging requirements for human and veterinary drugs have been regulated in one decree, which was adopted in 2002.
Based on the new regulations, a human drug marketing authorisation holder (MAH) will be obliged to place the name of their product in the Braille format on its outer packaging or the immediate packaging, where it has been omitted from the outer pack .On the request of patient organisations, the MAH will also be required to make available the drug’s packaging information leaflet in a format that is appropriate for the blind and partially-sighted. The decree furthermore lists a number of pictograms that may be used on drug packaging. However, their use will be allowed only if they make the information on the drug more clear to the patient and are not employed for promotional purposes.
The decree on packaging and information leaflet requirements that are obligatory for veterinary drugs will be enforced on 2 November 2008. It sets a list of details that must be contained in animal drugs packaging – including homeopathic medicines packaging – in accordance with Directive 2001/82/EC, amended in 2004. But the health ministry also offered the veterinary MAHs a possibility to introduce additional safety information on the packaging and information leaflet, under the condition that it has been approved during the authorisation procedure. The packaging and product information leaflets that are currently used and that do not comply with the conditions of the new decree will be allowed to remain on the market until November 2009.