lexiara

preamble_3209

5.2.2.1.11.3. Each label conforming to model number 7E shall be completed with the criticality safety index (CSI) as stated in the certificate of approval for special arrangement or the certificate of approval for the package design issued by the competent authority.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-31 · Text as adopted (Official Journal); later amendments are not incorporated in this text.