Léim ar aghaidh chuig an bpríomhábhar
Gnáthamharc

Dáil Éireann díospóireacht -
Thursday, 29 Nov 2001

Vol. 545 No. 3

Written Answers. - Animal Vaccines.

Tom Hayes

Ceist:

74 Mr. T. Hayes asked the Minister for Agriculture, Food and Rural Development when he intends to make the intra-mammary preparations available to farmers by prescription only; his plans to include cattle, sheep and pig vaccines; and if he will make a statement on the matter. [30268/01]

Tom Hayes

Ceist:

75 Mr. T. Hayes asked the Minister for Agriculture, Food and Rural Development the steps he intends to take to ensure harmonisation of legislation with regard to the availability of intra-mammary preparations and animal vaccines; and if he will make a statement on the matter. [30269/01]

I propose to take Questions Nos. 74 and 75 together.

As regards intra-mammary preparations, the Irish Medicines Board has recommended that these antibiotic medicines should be brought under prescription control. It is recognised in the relevant report from the IMB that there would be difficulties in applying the current prescription rules in Irish legislation to intramammaries. Accordingly, and in the context of the IMB proceeding with the prescription route, my Department is now engaged in considering what changes to existing legislation will be necessary in order to have an effective and workable prescription regime applying to intramammaries. My Department has sought the views and suggestions of stakeholders on the optimum arrangements which might apply. Some stakeholders have already responded and I expect this process to be completed within coming weeks. In formulating its proposals, my Department will not alone have regard to the views expressed by stakeholders, within the context of putting in place a suitable prescription regime but will also have due regard to arrangements in operation in other member states of the EU where prescription regimes currently apply to intramammaries.

As regards animal vaccines, I do not have a general policy that these products should necessarily be brought under prescription control. The current situation is that the marketing authorisations for animal vaccines are being reviewed on an individual basis in order to bring the licensing arrangements for such products fully into line with relevant EU legislative requirements. In this context, the detailed examination of application dossiers from sponsoring companies is carried out by the Irish Medicines Board who recommend to me, as competent authority, on the grant or otherwise of a licence and on the conditions to be attached to such licence, including the proposed designated route of supply. My decision, as com petent authority, accordingly takes full account of, but is not necessarily bound by, the recommendation from the IMB and as regards route of supply, as well as all other aspects, is based on the particulars of each case.
Barr
Roinn