Article 6 › 11

This Article 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 packaging of medical devices covered by Regulation (EU) 2017/745; (c) contact-sensitive 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) contact-sensitive packaging for infant formula and follow-on formula, processed cereal-based food and baby food, and food for special medical purposes as defined in Article 1, points (a), (b) and (c), of Regulation (EU) No 609/2013; (f) packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC; (g) sales packaging made from lightweight wood, cork, textile, rubber, ceramic, porcelain or wax; however, paragraph 8 shall apply to such packaging.

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