Detailed grounds for requesting a re-examination shall be submitted to the competent authority, the Agency, the competent authority agreed in accordance with Article 65(3) or the competent authority in the reference Member State, as applicable, within 60 days of receipt of the opinion or the assessment report.
Lorsqu’une autorité compétente ou la Commission en fait la demande, le titulaire de l’autorisation de mise sur le marché fournit sans tarder toute information relative à la mise en œuvre d’une modification.