ASEAN-Philippines The Rules and Regulations Implementing Republic Act No. 9711-The Food and Drug Administration Act of 2009

Issued by the Department of Health on March 22, 2011 pursuant to Section 22 of RA 9711, this four-book IRR operationalizes the FDA Act: Book I sets out the FDA's organizational structure (four product centers, the Office of the Director-General, administrative offices, regional field offices, satellite laboratories, and Regulatory Enforcement Units) and its income-retention scheme; Book II establishes the dual License to Operate (LTO) and Certificate of Product Registration (CPR) system with rules on automatic renewal, late-renewal surcharges, labeling, advertising, and laboratory accreditation; Book III lays down uniform administrative rules of procedure, sanctions, appeals, and execution; and Book IV provides transitory provisions for transferring personnel and assets from the former BFAD and BHDT.