protocol
as defined in Regulation (EU) 2024/573 of the European Parliament and of the Council of…, Article 3, point (7) (Definitions)
(7)
‘import’ means the entry of substances, products and equipment into the customs territory of the Union, in so far as the territory is covered by a ratification of the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer (the ‘Protocol’), and includes temporary storage and the customs procedures referred to in Articles 201 and 210 of Regulation (EU) No 952/2013;
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Also defined in
- Regulation (EU) 2024/590 of the European Parliament and of the Council of 7 February 2024 on substances that deplete… 32024R0590, Article 3, point (3)
1987 Montreal Protocol on Substances that Deplete the Ozone Layer - Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(2), point (22)
a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial. The term ‘protocol’ encompasses successive versions of the protocol and protocol modifications - Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws… 32001L0020, Article 2, point (h)
a document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments;