Vol. 546 No. 1
100 Mr. Allen asked the Minister for Health and Children if he will seek an explanation from the Irish Medicines Board as to the reason new anti-depressants and atypical anti-psychotic agents have not been licensed by the board for children and teenagers as recommended in a suicide prevention report carried out by the Western Health Board. [31186/01]
The Irish Medicines Board (IMB) can only license medicines when there is data to show that the product is safe and effective for the proposed indication in the targeted group of patients. The same criteria apply to applications for use of medicines in children or adolescents. For most medicines, pharmaceutical companies will present such information as soon as appropriate clinical trials have been performed. However, for new medicines such as anti-depressants or anti-psychotic agents, trials in children have not yet been done. If the pharmaceutical company has not performed studies in children, or has not made an application to the IMB for use in this age group then the IMB has no information on which to assess the safety or efficacy and as such cannot issue a licence.
