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La proposition de rvision de la directive en son article 18 dispose que les produits dont le niveau de nicotine excdant 2 mg/unit ou dont la concentration en nicotine excde 4 mg/ml ou dont lusage prvu entrane une concentration plasmatique maximale moyenne suprieure 4 mg de nicotine/ml doivent tre autoriss sur le march conformment la directive 2001/83/CE relative aux mdicaments usage humain

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