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Article 3

The registration, manufacturing, distribution and supervision of PEPPs shall be subject to: this Regulation; and in the case of matters not regulated by this Regulation: relevant sectorial Union law including the corresponding delegated and implementing acts; the laws adopted by Member States in implementation of relevant sectorial Union law and implementation of measures relating specifically to PEPPs; other national laws which apply to PEPPs.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-30 · Text as adopted (Official Journal); later amendments are not incorporated in this text.