These Rules and Regulations regulate unregistered imported drug product without a registered counterpart brand in the Philippines. If the unregistered imported drug product has a registered counterpart brand in the Philippines, the product shall be considered counterfeit. The provisions prohibited under Section 4 of R.A. 8203 are adopted as these rules and therefore punishable by the administrative sanctions. The Food and Drug Regulation Officers (FDROs) in the course of their inspection of a factory, warehouse, establishment or vehicle, processed or raw materials, containers and labelling therein upon the authority conferred by Section 27 of R.A. 3720, shall determine whether the drug products found are counterfeit or not. For the effective implementation of R.A. 8203, the said inspection shall be without prior notice in any place within the Philippines to prevent the parties liable from concealing them and avoiding inspection. Owners of trademarks, trade names or other identifying marks, or their authorized agents who have in their possession counterfeit drug products shall report in writing and tum over the said counterfeit drugs to the BFAD within 10 days from the time of purchase or acquisition of such drugs as indicated in the sales invoices or official receipts or other similar documents. The sales invoice, official receipts or other similar documents shall be attached to the said report on counterfeit drugs. Failure to comply with this section will give rise to the presumption of violation as provided under Section 4.
Filipinas · 1996-11-19