Article 7 › 4

Paragraphs 1 and 2 shall not apply to the following: (a) immediate packaging as defined in Article 1, point (23), of Directive 2001/83/EC and in Article 4, point (25), of Regulation (EU) 2019/6; (b) contact-sensitive plastic packaging of medical devices, devices exclusively destined for research use and investigational devices covered by Regulation (EU) 2017/745; (c) contact-sensitive plastic packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746; (d) outer packaging as defined in Article 1, point (24), of Directive 2001/83/EC and in Article 4, point (26), of Regulation (EU) 2019/6 in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product; (e) compostable plastic packaging; (f) packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC; (g) contact-sensitive plastic packaging for food that is intended only for infants and young children, food for special medical purposes and packaging for drinks and food typically used for young children as referred to in Article 1, points (a), (b) and (c), of Regulation (EU) No 609/2013; (h) packaging of supplies, components and immediate packaging components for the manufacturing of medicinal products covered by Directive 2001/83/EC and veterinary medicinal products covered by Regulation (EU) 2019/6, where such packaging is needed to be in line with the quality standards of the medicinal product.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26