Information related to Braille Labeling

(Issued by National Institute of Pharmacy)

"Please note that according to §2 (7) of the Decree 30/2005 (Aug 2nd) of the Minister of Health on labeling and package leaflet of medicines of human use "The name of the medicinal product and its strength, if more than one strengths are marketed, must also be expressed in Braille format on the outer packaging. If there is no outer packaging, this information should be expressed on the immediate packaging."
Measures regulated by above mentioned Decree shall first be implemented in the case of marketing applications submitted after the date of coming this Decree into effect. (October 30, 2005) Medicinal products already having marketing authorization at the time of coming this Decree into effect shall meet the requirements set out in this Decree for labeling and package insert not later than 31st December, 2010."

According to the above decree the outer packaging of all pharmaceuticals marketed in Hungary must display a Braille label by the end of 2010.

On the following flow-charts we suggest an efficient method for preparing the new labels. We indicated a route in blue whereby the company prepares a mock-up with Braille, prints final boxes with Braille labels and sends them to an Organisation for the Blind for certification. The red route shows when all this is done by the Organisation for the Blind professionally.

Why we suggest the route indicated in red:

-         problems often emerge because the Braille characters differ country by country

-         the final printed box is often refused because the size and especially the height of the dots may not be adequate

-     the costs involved are rather low so it is worth avoiding the risk of refusal which may lead to further loss of time and money.

 

                                          Suggested process for new products

 

                                    Suggested process for marketed products