S.L. 458.35 ст. 45Rapporteur to update assessment report.

Following the receipt of the comments referred to in regulation 44, the rapporteur or Member State shall within fifteen days update the assessment report taking into account any co mments su bmitt ed, an d f orward it to the Agency’s Pharmacovigilance Risk Assessment Committee. The Agency’s Pharmacovigilance Risk Assessment Committee shall adopt the assessment report with or without further changes at its next meeting and issue a recommendation. The recommendation shall mention the divergent positions with the grounds on which they are based. The Agency shall include the adopted assessment report and the recommendation in the repository set up under Article 25a of Regulation (EC) No 726/2004 and forward both to the marketing authorisation holder.