Dáil Éireann Debate, Wednesday - 17 September 2014
1161. Deputy Billy Kelleher asked the Minister for Health if consideration will be given to allowing L-carntine to be recognised as a medication rather than a food supplement; and if he will make a statement on the matter. [32953/14]
Amharc ar fhreagraUnder EU legislation, L-carnitine is one of the ingredients which can be added to foods for particular nutritional purposes. Foods presented with certain ingredients must comply with EU Regulation (EC) No. 953/2009 on the substances that may be added for specific nutritional purposes in such foods. These substances have first to be evaluated by the European Food Safety Authority before they can be considered for inclusion on the list of approved substances.
This does not mean however, that other products containing L-carnitine could not be recognised as medicines.
Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Health Product Regulatory Authority (HPRA) or in the case of certain medicinal products, the European Medicines Agency (EMA). To be classified as a medicine, the product has to make a medicinal claim. Clinical data to support the medicinal claim is required and the product has to meet the requirements of medicines legislation.
HPRA has advised that there is currently no application from a manufacturer seeking an authorisation under the medicines legislation.
