• Braille system
• Law regulations
• Packaging
• Braille labelling
• Contact us
• Po polsku

Braille labelling

Art. 56, 1st sentence, hereinafter called the directive provision, states that the name of the product should be put in Braille on the out package. What the term "name" means is basically defined in Art. 54 A. This means that, as the directive goes, there would be cases where a simple name of the product in one or two words is far from sufficient.

There may be cases where, according to the directive requirements, much more information is included in the name. It is recognized that the size of the carton or package in which the pharmaceutical product is sold, has a limited surface and that, therefore, it may be impossible to fit in all the information that the directive might require, if the standard size, spacing, etc. of the Braille symbols, cf. below, is to be adhered to.

For this reason, it is recommended:

• > That name in Art. 56, first sentence is understood as the unambiguous and distinguishable brand name with additional indication of strength or dosage to specify the product as different from other similar products with different strengths or active substances.
• > Any additional information providing detailed information about name, components in the product of active nature, expiry date, etc. cf. Art. 54 A are to be provided in a different manner through the means set up according to the patient leaflet accessibility provision.