Due to the government’s concern of the manufacturing and importing of counterfeit and unregistered pharmaceuticals in Malaysia, the Ministry of Health has recently issued the “Directive on the Use of the Hologram Security Device.” This regulation will require all pharmaceuticals, including health supplements, traditional products and OTC external personal care products, to bear a hologram security label, called a Meditag. The label will have a unique serial number, which verifies that the product has been registered with Malaysia’s Drug Control Authority (DCA) and can be traced to the licensed manufacturer or importer of the product. This new requirement will be implemented in two phases. Phase one will begin January 1, 2005 and require that non-parenteral products (non-injections) be labeled with the hologram. Phase two, labeling for injectable pharmaceuticals, will start July 1, 2005. Temperature-sensitive products that require cold chain maintenance, such as vaccines and biologicals, will not require a hologram. Additionally, cosmetics are will also be exempt from hologram labeling.
The hologram, which is approximately 8mm x 16mm, should be placed on the front panel of the product label on the outer packaging of the product. Each unit of sale will require a hologram and the customer should be able to see the hologram without opening the box/container. The local manufacturer (or the repacker in the case of products that are imported to Malaysia and packed locally) or the importer will be responsible for affixing the hologram label to the products. However, the labels may also be sent to the overseas manufacturer of the product, affixed overseas, and then imported pre-labeled.
Only one hologram manufacturer is authorized to sell, distribute and keep record of the holograms provided—Mediharta Sdn Bhd. Each label will cost RM0.056 (US 1.5 cents). A minimum order of either one roll (15,000 labels) or two sheets (100 labels/sheet) is required.
The Malaysia government expects pharmaceutical companies to plan for this new hologram labeling requirement and to avoid overstocking on products prior to the implementation of this Directive. However, a recall will not be necessary if products without the hologram remain on the shelves after January 1 or July 1 of next year. At that time, customers may simply choose whether they feel comfortable purchasing products without a hologram. But, if manufacturers do not show any attempt to meet the hologram labeling requirement next year, the Ministry of Health can suspend the product registration until the manufacturer/importer complies with the new regulation.