package leaflet
as defined in Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the…, Article 4(1), point (43)
(43)‘package leaflet’ means information for the user that 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; - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to… 32001L0083, Article 1, point (26)
A leaflet containing information for the user which accompanies the medicinal product.