E-Library - Information At Your Fingertips: Printer Friendly 37 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 (iii) Destruction and/or appropriate disposition of the subject health product and/or closure of the establishment for any violation of the FDA Act of 2009, these Rules and Regulations, other relevant laws, and FDA promulgated issuances. c. Regulatory Powers, Duties and Functions: (1) To issue appropriate authorizations that would establishments, facilities and health products[.][43] supplied) cover (Emphasis Unlike other quasi-judicial proceedings, legal concepts such as res judicata, stare decisis, and finality of decisions also have no application in certification and recertification proceedings. Science relies on innovation. Even if the scientific community conducts repeated scientific testing and continuous research, conflicting studies and research may always arise to challenge each conclusion. The issuance of a Certificate of Product Registration does not bind the Food and Drug Administration from further testing and investigation. The long-term effects of a new drug are not determined by a final and executory Court of Appeals or Supreme Court decision. Hence, any person may file an action once the health product is "found to have caused the death, illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, [and] dangerously deceptive."[44] The Food and Drug Administration is mandated to conduct Post Marketing Surveillance of contraceptives even after the issuance of the Certificate of Product Registration: Section 7.09. Post-Marketing Surveillance. All reproductive health products shall be subjected to Post-Marketing Surveillance (PMS) in the country. The PMS shall include, but not be limited to: examining the health risk to the patient, and the risk of pregnancy because of contraceptive failure. The FDA shall have a sub-unit dedicated to reproductive health products under the Adverse Drug Reaction Unit who will monitor and act on any adverse reaction or event reported by consumers and health professionals or workers. The system for reporting adverse drug reactions/events shall include online reporting at the FDA and DOH website, along with established reporting mechanisms, among others. Companies with registered products shall be required to have a PostMarketing Surveillance department, division, section, unit, or group that will monitor and investigate all health-related reactions or risks, or failure of the product to prevent pregnancy.[45] 4/21/2020, 9:19 AM