outer packaging
as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of…, Article 2(1) (Definitions)
For the purposes of this Regulation, the definitions of ‘medicinal product’, ‘radiopharmaceutical’, ‘adverse reaction’, ‘serious adverse reaction’, ‘immediate packaging’ and ‘outer packaging’ set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply.
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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 (26)
packaging in which the immediate packaging is placed; - 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 (24)
The packaging into which is placed the immediate packaging.