Código de la Unión sobre medicamentos para uso humano y derogación de la Directiva 2001/83/CE y la Directiva 2009/35/CE

Presentada por Annalisa Tardino, Anders Vistisen, Aurélia Beigneux

3. Eliminado: Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, Añadido: By default, a package leaflet in paper format shall be included in the packaging of a medicinal product. Eliminado: If Añadido: Member States may decide that the package leaflet Eliminado: is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge Añadido: shall be made available electronically as well, and it should be ensured that the information in digital format is …

Texto tal como lo publica el PE, en inglés. PE760.538