lexiara

sec_11__para

Text with EEA relevance.

11.1. Reassessment is similar to an initial assessment except that experience gained during previous assessments shall be taken into account. Surveillance on-site assessments are less comprehensive than reassessments.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-12 · Text as adopted (Official Journal); later amendments are not incorporated in this text.