Seán Power (Kildare South, Fianna Fail)

The objective of amendments Nos. 2, 3, 14 and 15, made to the Animal Remedies Act 1993, fall into two broad categories. The first is to ensure an adequate legal basis in the future for the collection of fees by the IMB arising from changes in EU legislation. The second objective is to use this opportunity to update and express in euro amounts the penalties provided for under the Act for breach of licensing and other requirements.

I draw Senators' attention to the fact that under the Animal Remedies Act 1993 and regulations made thereunder, the IMB acts as a licensing authority with respect to veterinary medicines, animal remedies and the manufacturing plants in which such products are made. Section 29 of the 1993 Act provides the basis for the collection of fees for these services, which are fixed by the Minister for Agriculture and Food with the consent of the Minister for Finance.

A new framework EU legislation governing veterinary medicines — Directive 2004/28/EC — has come into force in this area. It has been transposed into national law by means of the Animal Remedies Regulations 2005. One of the changes brought about by the new EU legislation is a shift away from time-bound authorisations to open-ended authorisations. This change puts greater emphasis on ongoing supervision by licensing authorities and on reporting obligations applying to licence holders.

Up to now the emphasis has been on licences which were renewable after five years. The Animal Remedies Act 1993 provides an adequate legal basis for the charging of fees by the IMB in respect of these services. However, in view of the change in emphasis to open-ended authorisations, it is of critical importance to ensure that, in future, the legal basis for fees charged by the IMB, both for human and veterinary medicines, is extended to cover the changed demands placed on the board by the new EU regulatory framework. Accordingly, the amendments to sections 8 and 29 make specific provision for annual fees in respect of open-ended licences.

These amendments also clarify the IMB's inspection role with regard to manufacturing plants and that fees are collectable for this activity, as well as other services such as certification. With regard to the amendments to section 23, it is appropriate to bring penalties under the 1993 Act fully up to date and express them in euro amounts. I draw Senators' attention to changes in the penalties for summary offences. On the advice of the Parliamentary Counsel, the maximum penalty which can be imposed in the District Court is being increased to €5,000 in line with the current norm.

Overall, the amendments are both prudent and appropriate for a measure which relates to the statutory activities of the IMB. The amendments to section 1 introduce a citation regarding the Animal Remedies Act 1993.