XVI.App1.3. Labelling of immediate and outer packaging

The labelling (see GVP Annex I) of all medicinal products contains a warning that the medicinal product must be stored out of the reach and sight of children [DIR Art 54(f)]. The Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use34 and the Template for the Labelling of the Immediate and Outer Packaging35applies to labelling.

XVI.App1.3.1. Special warnings and information on precautions

According to the legislation [DIR Art 8(3)(j), DIR Art 54, REG Art 6(1)] and the Template for the Labelling of the Immediate and Outer Packaging36 , the labelling may contain a special warning if this is necessary for the medicinal product [DIR Art 54(g)] and, where appropriate, information on specific precautions for the disposal of unused medicinal product or waste derived from a medicinal product [DIR Art 54(j)].

XVI.App1.3.2. Pictograms

According to the Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use37, pictograms may be presented in the labelling if accepted for the medicinal product in accordance with Article 62 of Directive 2001/83/EC and where space on the packaging permits, provided they do not interfere with the legibility of the mandatory information in the labelling.