Braille: product name in Braille on the outer packaging

Article 56a of Directive 2001/83/EC, introduced by Directive 2004/27/EC, requires the name of the medicinal product, as listed in Article 54(a), to be expressed in Braille on the outer packaging. Where a product exists in more than one strength, the strength is included. The same article requires the marketing authorisation holder to ensure that the package leaflet is made available on request from patient organisations in formats appropriate for blind and partially sighted people, which in practice means large print, audio or an electronic file. The Commission's guidance on the Braille requirements for labelling and the package leaflet, published in the Notice to Applicants, explains how the rule is applied, and the CMDh and EMA follow it in their review of mock-ups.

The guidance recommends uncontracted Braille, since contracted systems differ between languages and would make multilingual packs unreadable, and the Marburg Medium standard for dot size and spacing because it is widely used across the EU. The Braille name is usually embossed on the carton, which must be designed with enough flat space, and it is shown on mock-ups as dots in the correct position, not as a note. The pharmaceutical form is included only where it is needed to distinguish products with the same name, and multilingual Braille follows the rules of the languages concerned. Member States can decide not to require Braille on small packs, and products that are not intended to be handled by patients, such as those administered only by healthcare professionals in hospital, can be exempted on request.

What goes wrong: the Braille is omitted or wrong on a pack whose name changed after a variation; the dots are flattened by overprinting or placed across a fold; the strength is missing on a product that later gained a second strength; an exemption claimed at authorisation is carried forward after the product moves to self-administration; multilingual packs mix contracted and uncontracted Braille; and the obligation to provide the leaflet in accessible formats is forgotten entirely because nobody requests one until a patient organisation does. Authorities check Braille at mock-up review, so a fault found late can delay the national phase of a decentralised procedure and the launch that depends on it.