Gov?t compels PH drug firms to adopt electronic ID system

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The FDA (formerly known as BFAD or Bureau of Food and Drugs) building in Muntinlupa City. Photo credit: wikimapia.org The FDA (formerly known as BFAD or Bureau of Food and Drugs) building in Muntinlupa City. Photo credit: wikimapia.org[/caption] The policy was issued last April 29 through FDA Circular 2014-011 signed by FDA director Kenneth Y. Hartigan-Go. The new regulation will take effect one year after its issuance or starting June 2015. Under the circular, a unique identification code is assigned to each product. A barcode, a Quick Response (QR) code, or any electronic identification mark is given to each product. The circular mandates that all establishments should obtain a Global Trade Item Number or GTIN from an independent agency. With the GTIN assigned to each product, any product found hazardous to health may be traced to its manufacturer anywhere in the world. Each GTIN is permanently assigned as the identification number of each product associated with a company. The number has no expiration. Likewise, each manufacturing batch or lot should have its own GTIN. The system ensures traceability which protects customers as the product can be identified to a specific source or manufacturer of whatever country under this globally recognized system. The GTIN should also be reflected in labels of products, the circular said. ?Appropriate identification numbers must be displayed on the product exterior in a manner that allows unaided visual verification by a majority of consumers,? said the circular. ?Failure to provided a verifiable GTIN by itself is sufficient ground for denial of (a product?s FDA) application.? The UGP-IN, the circular noted, is issued by international organizations and implemented in more than 100 countries. It also recognized by the World Customs Organization and the World Health Organization. ?A global product identification system strengthens enforcement against counterfeit products, facilitates execution of risk management plans including recalls and bans, and enables global identification of products manufactured in the Philippines by local companies,? said the FDA. The UGP-IN is similar to system espoused by GS1, international non-profit association. The GS1 system is being pushed by its local office here in the country. Philippine representatives of the GS1 global organization said FDA?s adoption of the new policy indicates government?s strong support for the distribution of high-quality drugs and health products in the country. ?Through this ID system, we will be able to ensure the right medicine is administered on patients. Expired drugs? being found in the market will become a thing of the past,? said Edward David who is with the GS1 local office. Because there will be reliable bar code system, fake medical products may easily be identified, David said. The Asia Pacific Economic Cooperation (Apec) Ministers Meeting issued in October 2013 a statement supporting global data standards that assure food and drug safety. ]]>

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