1.4.2.
The establishment of the consistency and concordance of a substantial number of clinical observations may, if appropriate, take the place of the analyses referred to in point 1.4.1. Clinical analyses may, in appropriate cases, take the place of the analyses referred to in point 1.4.1 provided that the consistency and concordance of a substantial number of observations enable the same results to be obtained.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-10 · Text as adopted (Official Journal); later amendments are not incorporated in this text.