Seán Power (Kildare South, Fianna Fail)

These amendments delete the references to the amendment of licences and authorisations from section 9(9) of the Irish Medicines Board Act 1995. Section 9(9) obliged the board to notify the appropriate advisory committee whenever the board grants, suspends, renews, revokes or amends an authorisation in respect of a medicinal product. In view of the fact that over 11,000 such amendments are made annually, the implications of requiring such notifications would be significant for both the board and the advisory committee and would effectively render the purpose of the notification and scrutiny process ineffective. In these circumstances the amendments were made so as to discontinue the need to notify amendments, which will enable the advisory committee to concentrate on the more significant issues which arise with the granting, suspension, renewal or revocation of licences or other authorisations.