BRUSSELS UPDATE
EMEA advises on clear labelling for medicines
Streamlined guidelines have been released by the European Medicines Agency (EMEA) on ensuring pharmaceuticals sold in the European Union (EU) have packaging, labelling and explanatory leaflets easily understandable in all EU languages. Manufacturers have to submit specimen templates which can be examined by EMEA language experts. An agency memorandum stresses that the “safe and correct use of all medicines” must depend on “users reading the labelling and packaging accurately”. Its advice includes information on producing Braille instructions, and also those for the partially sighted, as well as other special needs patients, among them younger people. Pictograms are allowed, but not if they commercially promote a product. *http://www.emea.eu.int/pdfs/human/regaffair/30582106en.pdf
EU Council takes liberal approach to pre-packaging
The European Union (EU) Council of Ministers has taken a liberal approach to fixed pre-packaging sizes in the EU, voting to scrap all restrictions except for those on wines and spirits, where the present fixed sizes will largely remain. Ministers deleted amendments passed by the European Parliament that would have retained fixed EU pack sizes for drinking milk, ground coffee, pre-packed bread, spreadable fats, tea, dried pasta, rice and brown sugar. The proposed reforms will now return to the parliament, which has veto rights and could insist on restoring the pack sizes. However, EU member governments were unanimously agreed on liberalising, increasing pressure on MEPs to abandon the restrictions.
EC survey warns of fake packaging blackspots
A European Commission global survey into counterfeit goods has revealed concerns about Mexico being a centre for the counterfeiting of fake medicine packaging and leaflets. The study of businesses, industrial federations and diplomatic missions was told the problem is particularly rife in the large cities of Mexico City, Guadalajara, and Monterrey, along with the northern frontier zone with the United States.
In Indonesia, importing companies reported using holograms on all kinds of packaging and making regular changes to pack designs in attempts to prevent counterfeit good sales. And in the Ukraine, the survey revealed concerns about counterfeit leaflets and packaging, and even the piracy of pack materials, for later assembly.
