(c)

where necessary, the competent authority shall be empowered to require the manufacturer or, where appropriate, the importer, to produce the scientific work and the data establishing the product's compliance with Article 1(2) and (3) together with the information provided for in point (a) of Article 9(3). If such work is contained in a readily available publication, a mere reference to this publication shall suffice.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.