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3.

When assessing the acceptability of the report mentioned in paragraph 2, the Commission will make reference to its guidance on the demonstration of equivalence (to be published). Where Member States have been using interim factors to approximate equivalence, the latter shall be confirmed and/or amended with reference to the Commission's guidance.

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Source: EUR-Lex CELLAR · retrieved 2026-08-09 · Text as consolidated on 2015-09-18; changes after this date are not shown.