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as defined in Commission Regulation (EU) No 316/2014 of 21 March 2014 on the application of…, Article 1(1), point (i) (Definitions)

a package of practical information, resulting from experience and testing, which is: (i) secret, that is to say, not generally known or easily accessible, (ii) substantial, that is to say, significant and useful for the production of the contract products, and (iii) identified, that is to say, described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality;

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