§ Mr. StottTo ask the Secretary of State for Health if(a) Seatone green lipped mussel extract capsules and (b) Kwai concentrated garlic tablets have been subjected to the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994. [19137]
§ Mr. SackvilleResponsibility for this matter has been delegated to the Medicines Control Agency under its chief executive, Dr. Keith Jones. I have asked him to reply to the hon. Member.
Letter from K. Jones to Mr. Roger Stott, dated 18 April 1995:
The Secretary of State has asked me to reply to your question about Seatone capsules and Kwai tablets, and the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994.The Regulations provide that from 1 January 1995, unless exempt, no medicinal product may be placed on the market in the United Kingdom without a marketing authorisation. Article 1.2 of Directive 65/66 EEC defines a medicinal product as one which is presented for treating or preventing disease, or one which "may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions". (Most medicinal products in fact qualify on both the "presentation" and "function criteria".)In the case of the products you have asked about, the Agency has regularly monitored their status. On the basis of the information currently before it, the Agency considers they do not fall within either limb of the definition of a medicinal product. They are not, therefore, subject to the Marketing Authorisation etc. Regulations.