Product Information Text: Formats Suitable For Blind & Partially Sighted

Braille is an internationally recognised reading and writing system used by blind and partially sighted people. The braille alphabet consists of various arrangements of raised dots that make up each character. In accordance with European legislation, braille is required to be expressed on pharmaceutical packaging.

As per Directive 2001/83/EC (as amended by Directive 2004/27/EC; Article 56a), the Marketing Authorisation Holder (MAH);

  • is required to express the name of the medicinal product in braille format on the packaging
  • must ensure that the package leaflet is available in formats appropriate for the blind and partially sighted.

Information to be expressed

The invented name (as per section 1 of the SmPC) and strength must appear in braille format on the outer packaging of medicinal product, however where the product is authorised in a single strength, it is acceptable to include the invented name only. Where more than one pharmaceutical form is available, it is recommended to include the pharmaceutical form also in braille format.

Braille is not required on the packaging of medicinal products intended for administration by healthcare professionals only.

Availability in appropriate formats

If a consumer or other source requests a copy of the package leaflet in a format suitable for blind or partially sighted patients, the MAH must promptly fulfil this request. Such formats could include braille, CD, audiocassette or large print.

The MAH must ensure that the current version of the package leaflet is supplied and the “accessible” package leaflet must not be abridged in any way.

Where no separate package leaflet exists, the information provided on the approved labelling must be provided in formats suitable for the blind and partially sighted.

For further information on how Acorn Regulatory can help you meet the requirements of article 56(a) please contact us at 052 6176706. Alternately, you can complete the webform below and we will get back to you.

About the Author
Eileen Shortiss
Senior Regulatory Affairs Advisor - Pharmacovigilance
Eileen Shortiss joined Acorn Regulatory in 2006. During her time with Acorn Regulatory, Eileen has worked on a vast array of projects for clients all over the world. Eileen is extensively involved with pharmacovigilance KPIs and driving continuous improvement measures across the department. Furthermore, she has considerable expertise and experience in the area of patient information leaflets. You can read other articles by Eileen Shortiss by clicking the link below.
Other articles by Eileen Shortiss