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Rules and Guidelines on the Issuance of Import Permit as “Samples Only” for FDA Regulated Products Intended for Research and Development Purposes

Rules and Guidelines on the Issuance of Import Permit as “Samples Only” for FDA Regulated Products Intended for Research and Development Purposes

I. Rationale/Background

It is the policy of the State as embodied in Article II, Section 15 of the 1987 Constitution to protect and promote right to health of the people and in Section 12, Article XIII of the 1987 Constitution to establish and maintain an effective food and drug regulatory system. In the implementation of the foregoing, Section 15 (2), Chapter (4) Title IX, Book IV of the Administrative Code of 1987 authorizes the Food and Drug Administration to act as the policy formulation and sector monitoring arm of the Secretary of Health on matters pertaining to food, drugs, traditional medicines, cosmetics and household products containing hazardous substances. Further, the Center for Food Regulation and Research (CFRR) in accordance with Republic Act No. 9711 “shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products.”

In view thereof, the CFRR, through this issuance, obligates the concerned establishments to secure Import Permit prior to importation of prepackaged processed food product including bulk food and raw materials intended as samples for research and development purposes.

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