FD CEN/TR 15753

Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people

Le présent document traite de la fourniture d'informations sur les médicaments dans des formats adaptés aux personnes aveugles ou malvoyantes. Il fournit des lignes directrices à l'appui de l'exigence de la Directive 2001/83/CE amendée par la Directive 2004/27/CE, concernant la fourniture au sein de l'Union européenne (UE) et de l'Espace économique européen (EEE) de notices en formats lisibles par les personnes aveugles ou malvoyantes dans les emballages (conditionnements) de médicaments.

To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

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