E-Library - Information At Your Fingertips: Printer Friendly 36 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 It is also for this reason that the Implementing Rules and Regulations of Republic Act No. 9711 include the issuance of authorizations, including Certificates of Product Registration, as part of its regulatory functions, and not its quasi-judicial functions: b. Quasi-Judicial Powers, Duties and Functions: (1) To render decisions on actions or complaints before the FDA pursuant to the FDA Act of 2009, these Rules and Regulations, other existing laws, and FDA-promulgated issuances; (2) To hold in direct or indirect contempt any person who disregards orders or writs issued by the FDA and impose the appropriate penalties following the same procedures and penalties provided in the Rules of Court; (3) To administer oaths and affirmations and issue subpoena duces tecum and subpoena ad testificandum requiring the production of such books, contracts, correspondence, records, statement of accounts and other documents and/or the attendance and testimony of parties and witnesses as may be material to any investigation conducted by the FDA; (a) To obtain information from any officer or office of the national or local governments, government agencies and its instrumentalities; (5) To issue orders of seizure, to seize and hold in custody any article or articles of food, device, cosmetics, household hazardous substances and health products that are adulterated, counterfeited, misbranded or unregistered; or any drug, in-vitro diagnostic reagents, biologicals, and vaccine that is adulterated or misbranded, when introduced into domestic commerce pending the authorized hearing under the FDA Act of 2009, these Rules and Regulations, and as far as applicable, other relevant laws; and (6) To impose the following administrative sanctions/penalties for violations of the provisions of the FDA Act of 2009, these Rules and Regulations, and where applicable, other relevant laws, after observance of and compliance with due process: (i) Cancellation of any authorization which may have been granted by the FDA, or suspension of the validity thereof for such period of time as he/she may deem reasonable, which shall not exceed one (1) year; (ii) A fine of not less than Fifty Thousand Pesos (Php50,000.00), but not more than Five Hundred Thousand Pesos (PhP500,000.00). An additional fine of not more than One Thousand Pesos (PhP1,000.00) shall be imposed for each day of continuing violation; 4/21/2020, 9:19 AM

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