package leaflet
as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6…, Article 1, point (26)
A leaflet containing information for the user which accompanies the medicinal product.
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Also defined in
- Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal… 32019R0006, Article 4, point (27)
a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use;