outer packaging
as defined in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11…, Article 4, point (26) (Definitions)
packaging in which the immediate packaging is placed;
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Also defined in
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(1)
set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply - 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.