Administrative Order No. 2016-0008
Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human Use
Article III, Section 7 of the 1987 Philippines Constitution declares that the state recognizes the right of the people to gain information on matters of public concern, such as those relating to health and health products.
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Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices
As provided by the 1987 Constitution, it is the State's policy to protect and promote the right to health of the people and instill health consciousness among them (Sec. 15, Art. II). This includes the adoption of an integrated and comprehensive approach to health development which shall endeavor to make essential goods, health and other social services available to all the people at affordable cost (Sec. 11, Art. XIII), as well as the establishment and maintenance of an effective food and drug regulatory system (Sec. 12, Art. XIII), among others.
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Administrative Order 2016-0003
Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA)
The 1987 Philippine Constitution mandates the establishment of an effective food and drug regulatory system that is responsive to the country's health needs and problems.
Consistent with said constitutional provision, Congress passed landmark legislations, namely Republic Act (RA) No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by RA No. 9711 (Food and Drug Administration Act of 2009), RA No. 10611 (Food Safety Act of 2013), and RA No. 9502 Universally Accessible Cheaper and Quality Medicine Act of 2008) mandating FDA to regulate establishments engaged in health products to ensure consumer safety, welfare protection, and fair practice
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