Dáil Éireann Debate, Tuesday - 6 November 2018
524. Deputy Clare Daly asked the Minister for Health to outline his plans to allow the sale of 5-hydroxytryptophan here; and the reason it has not been permitted for sale over the counter or on prescription to date. [44746/18]
Amharc ar fhreagraProducts containing 5-hydroxytryptophan (5-HTP) are considered to be medicines in Ireland. 5-HTP is reported to have actions in the body that could potentially be used to treat some medical conditions such as depression. Under national and European legislation, products for which medicinal claims are made, or which contain substances that could have medicinal effects on the body, are considered to be medicines.
All medicines must have a marketing authorisation prior to being placed on the Irish market. At present no medicine containing 5-HTP is authorised for use in Ireland. An application for a marketing authorisation for a medicine containing 5-HTP could be submitted by any company that has compiled data demonstrating the quality, safety and efficacy of the product and any such application would be reviewed in line with the standard requirements for medicines.
Where a medicine is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility and to meet the special needs of a patient. The process for this is described in the ‘Guide to the Notification System for Exempt Medicinal Products’ which is available on the website of the Health Products Regulatory Authority.
The decision to prescribe or not prescribe any treatment, including 5-HTP, for an individual patient is a decision for the treating clinician, in consultation with their patient.
