Braille is an international reading and writing system for blind and partially-sighted people. It is not a language, just another way to read and write a language.
EU requirements for Braille on packaging and labelling of homeopathic and anthroposophic medicinal products vary according to how they are licensed.
Products with a marketing authorisation
Directive 2001/83/EC requires homeopathic and anthroposophic medicinal products authorised according to Article 16 (marketing authorisation) to be labelled in accordance with Article 54. Article 56a of the Directive applies to these products. The name of the medicinal product must be expressed in Braille format on the packaging and the package information leaflet made available on request from patients’ organisations in formats appropriate for blind and partially-sighted people.
The Guideline on the readability of the labelling and package leaflet of medicinal products for human use (2009) makes an exemption (Chapter 2, Specific recommendations for blind and partially sighted patients) from the obligation for Braille on the packaging of products which are only intended for administration by health care professionals.
Products registered according to Article 14
The situation for homeopathic medicinal products licensed under Article 14 (simplified registration) of Directive 2001/83/EC is less clear. Different Member States handle this regulation in different ways, and some require Braille for these products, while some do not.
The labelling requirements for these products are determined by Article 69, which lists the mandatory information that has to appear on the packaging and stipulates that no other information may be given. Since Braille is not mentioned in this article, according to Directive 2001/83/EC, it is not mandatory to put it on the packaging of Article 14 products.
However, the European Commission’s ‘‘Procedures for marketing authorisation’ (Notice to applicants Vol. 2A Chapter 1, June 2013, p17) states that there is no waiver from the Braille requirements for homeopathic medicinal products registered through the simplified procedure during a Mutual Recognition or a Decentralized Procedure.
ECHAMP has sought legal advice in order to clarify this contradictory legal background. The expert legal statement clearly confirms that the European Commission’s opinion is not in line with the stipulations of Directive 2001/83/EC.