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Dáil Éireann debate -
Wednesday, 5 Apr 2000

Vol. 517 No. 4

Written Answers. - Prescription Requirements.

Róisín Shortall

Question:

186 Ms Shortall asked the Minister for Health and Children the procedures in place to review drugs which require a prescription; if there is a mechanism whereby the prescription requirement for a drug can be dropped following a period of time during which the drug displays no side affects; the average time period in this regard; if the prescription requirement for St. John's Wort will be reconsidered in this context; and if he will make a statement on the matter. [10149/00]

In the classification of those drugs which are to be subject to prescription only control the criteria described in Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use are applied. Under these criteria medicinal products are subject to medical prescription where they: are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision, or are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or contain substances or preparations thereof the activity and-or side effects of which require further investigation, or are normally prescribed by a doctor to be administered parenterally.

In the normal course of events, a review of the legal classification takes place on the occasion of the five-yearly renewal of the product authoris ation concerned or when new information is made available.
In the absence of a product authorisation, as in the case currently with St. John's Wort, the necessary pharmacovigilance and other safety information would not be likely to become available in order to enable such a change to be made.
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