1.

If particulars recorded in the information package have changed, without requiring inspections or tests to be repeated, the amendment shall be designated a ‘revision’. In such cases, the approval authority shall issue the revised pages of the information package as necessary, marking each revised pages to show clearly the nature of the change and the date of reissue. A consolidated, updated version of the information package, accompanied by a detailed description of the changes, shall be deemed to meet that requirement.

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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.