Tim O'Malley (Limerick East, Progressive Democrats)

This amendment is one of a number made necessary by the judgment of the Supreme Court in the case of Vincent Browne v. the Attorney General and others, where powers are being created which would enable the implementation of Acts of the European Communities, such as directives and regulations, by means of secondary legislation. This amendment, taken with other related amendments which follow immediately, will enable appropriate implementation of EU obligations in this country, where medicinal products for human use, medical devices and cosmetic products are concerned.

Amendment No. 40 is a consequential renumbering of the paragraphs following an earlier insertion. Amendment No. 41 substitutes two new subsections for sections 32(3) and 32(4) of the Irish Medicines Board Act 1995. The new section 32(3) provides for the introduction of such incidental, supplementary and consequential provisions as may be necessary for the implementation of Acts of the European Communities relating to medicinal products. As is standard in such implementation, it is being provided that existing laws, including Acts, may be appropriately amended. The new section 32(4) converts to convenient euro amounts the financial penalties established in the Irish Medicines Board Act 1995.

Amendment No. 42 is a technical drafting amendment arising from amendment No. 41.