Vol. 441 No. 3
77 Mr. McGrath asked the Minister for Health the reason for the status of products (details supplied) one of which appears to have obtained the status of a medical product while the other is deemed to be a health food; if he has received any representation regarding the status of either product; if he intends to introduce any changes in this area; and if he will make a statement on the matter.
I understand that the Deputy is referring to the question of the need or otherwise for the companies referred to to hold a licence under the Medical Preparations (Licensing of Manufacture) Regulations, 1993 (S.I. No. 40 of 1993). Both companies are engaged in the distribution of a range of products commonly referred to as health food products such as vitamins and mineral supplements. These products may be classified as either food supplements or medical preparations depending on a number of factors including the daily recommended intake.
In the case of the first company referred to, its product range was originally judged to be in the category of food supplements, but this range is now expanding to include products deemed to be medical preparations. The company, accordingly, in January 1994 made application for a licence under the Medical Preparations (Licensing of Manufacture) Regulations, 1993 and that application is currently under examination. Similarly, in the case of the second company, a number of its products fall within the definition of medical preparations and it was granted a manufacturer's licence in March 1993.
I have received no representations on this matter, although companies dealing in these products regularly meet with officials of my Department for advice and guidance in the classification of these products. There are no proposals for any changes in this area at present.
