Circular of the Deputy for Supervision over Traditional Medicines, Cosmetics and Complementary Product No. PO.01.04.4.41.053 on labelling of warning in food supplement containing Vitamin K

17A LABELING OF WARNING IN FOOD SUPPLEMENT CONTAINING VITAMIN K (Circular of the Deputy for Supervision over Traditional Medicines, Cosmetics and Complementary Product No. PO.01.04.4.41.053 dated March 16,2007) To: Executives of Pharmaceutical Companies/Industries Throughout Indonesia In a bid to protect public health from risks aris ing from the use of products not fulfilling the security requirements, the following information is provided: 1. Companies havingfood supplement containing Vita min K must improve label by mentioning warning: Do Not Giveto People in the Course of Treatmenty by Warfarin or the similar medicine". 2. The revised label-should be given up to the Food and Drug Supervisory Board in this case the Directorate of Traditional Medicine, Food Supplement and Cos metic Evaluation. 3. Food supplement containing Vitamin K '4Iith the old Jabeland produced before the issuance of this circu lar can be distributed and must adjust to the provi Business News 7513-7514/5-23-2007 sion in this circular in a transmonat period of 6 (SIX) months as from the date of issuance of this circular. 4. In the case of the provision being not yet fulfilled after the deadline elapses, the relevant shall be subject to sanction in the form of withdrawal of products and nullificaton of approval number of registration. This is for your proper implementation. ForTHE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD DEPUTY FOR SUPERVISION OVER TRADmONAL MEDICINES, COSMETICS AND COMPLEMENTARY PRODUCTS Sgd Drs. RUSLAN ASPAN, Apt,MM (R)------