Dáil Éireann Debate, Thursday - 28 October 2004
117 Caoimhghín Ó Caoláin asked the Tánaiste and Minister for Health and Children the way in which her Department independently monitors and screens vaccines imported into Ireland in order to provide safeguards against contamination. [26420/04]
View answer118 Caoimhghín Ó Caoláin asked the Tánaiste and Minister for Health and Children if contaminated stocks of a drug (details supplied) were distributed in the State prior to the notification given to the Irish Medical Board on 9 September 2004 of sterility problems with the product; the steps which were taken to prevent distribution of the contaminated drug; and if she will make a statement on the matter. [26421/04]
View answerI propose to take Questions Nos. 117 and 118 together.
The Irish Medicines Board, IMB, is the national competent authority responsible for the licensing of the manufacture, preparation, importation, distribution and sale of all medicinal products for use in Ireland.
There are inspectors in each competent authority in Europe. If the manufacturing site is in Ireland, inspectors from the IMB inspect to see that the products are made to the appropriate quality and, if so, issue the manufacturing licence, which is recognised by the rest of Europe. In the case of the flu vaccine, the manufacturing site is in the UK and, therefore, the Medicines and Healthcare Products Regulatory Agency, MHRA, inspectors inspect the manufacturing site and grant, suspend etc., the manufacturing licence. The UK inspectors inform the Irish Medicines Board of their findings as necessary. Apart from the quality controls at the manufacturing site, after a batch of vaccine is released from the manufacturing site but before it reaches the Irish market, it is a condition of the licence that, "No batch shall be marketed in Ireland unless first released in accordance with Article 4 of Directive 89/342/EEC." This means a batch of vaccine cannot be imported or used in Ireland unless first released by an independent control agency. No stocks of Fluvirin vaccine manufactured at the Chiron site in Liverpool arrived in Ireland. There are no quality relating to the influenza vaccine, Agrippal, that came to Ireland from the Chiron manufacturing site in Italy.
