Braille and package leaflets for the visually impaired

Directive on human medicines Article 56a of the Directive on human medicines 2004/27/EC lays down the following provisions on the use of Braille in labelling: "The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patient associations in formats appropriate for the blind and partially-sighted."

Fimea Administrative Regulation

Pursuant to the Fimea Administrative Regulation 3/2019 "Labelling and package leaflets for medicinal products" the trade name of the medicinal product (and strength, if necessary) shall be indicated on the outer packaging in Braille of an approved standard. The requirement does not apply to medicinal products, veterinary medicinal products or emergency packages intended solely for hospital use or administration by health care professionals only. All other medicinal products released on the market have been labelled in Braille since 30 October 2010.

The Braille conventions shall comply with the recommendations of the Braille Advisory Board of the Finnish Ministry of Education and patient associations (Finnish Federation of the Visually Impaired). Concerning the package leaflets for the visually impaired, the Fimea Administrative Regulation 3/2019 states that at the request of the patient association (Finnish Federation of the Visually Impaired), the holder of marketing authorisation or registration must provide the package leaflet in a format intended for the visually impaired (Braille, large print, recording or accessible electronic format).

The content of the package leaflet must correspond to the package leaflet approved for the medicinal product. Fimea does not separately review or approve the package leaflets for the visually impaired.

Fimea Normative Guideline

The Fimea normative guideline 1/2019 "Labelling and package leaflets for medicinal products" presents other factors that further promote the correct use and safe use on medicinal product packages. When assessing the usability of the packages from the perspective of the visually impaired, particular attention must be paid to text size, font, colours and design.