MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging
Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of over-the-counter (OTC) medicinal products (i.e. non-prescription medicinal products) must contain 'instructions for use'. This also includes the complete indication area, in line with the Summary of Product Characteristics (SmPC). This statement must be described in patient-friendly language, in accordance with the package leaflet.
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