Administrative Order No. 15-a s. 1981 on FDA Guidelines Governing Simplified Export Procedures under Presidential Decree No. 930

Republic of the Philippines Ministry of Health OFFICE OF THE MINISTER M a n i l a October 4, 1981 ADMINISTRATIVE ORDER No. 15-a s 1981 SUBJECT: FDA GUIDELINES GOVERNING SIMPLIFIED EXPORT PROCEDURES UNDER PRESIDENTIAL DECREE NO. 930. Pursuant to Section 3 of Presidential Decree No. 930 otherwise known as Export simplification Decree, the following FDA guidelines are hereby promulgated for the information and guidance of all concerned. Section 1 – Any person or establishments desiring to export food and food products shall secure a License to Operate as exporter/trader from the Food and Drug Administration. Section 2 – Any person desiring to exporter/trader food and food products shall file an application for the registration of same with the Food and Drug Administration, in accordance with Administration Order No. 37 s. 1979. Section 3 – Any exporter/trader of food or food products shall secure a commodity clearance from the FDA. Section 4 – A commodity clearance shall be issued for products conforming to established quality standards, and other FDA requirements. Section 5 – When necessary and to check the quality of food and food products for export prior to leading, these commodities maybe inspected and sampled by FDA Inspectors for analysis and examination. Section 6 – A periodic commodity clearance may be granted to: a) food and food product that have been evaluated and found consistently given satisfactory results in bacteriological and chemical analysis; b) food and food product that have been manufactured in accordance with the Good Manufacturing Practice (GMP) A.O. 208 s. 1974; c) food and food product that is stable as shown by the manufacturer’s stability studies; and d) food and food products that have no record of rejection or detention in any importing countries. Section 7 – The validity of the periodic commodity clearance shall depend on the kind of food and food product intended for export. Section 8 – For every commodity clearance issued, the following laboratory examination fees shall be collected: a) commodity clearance per shipment (one time) - - - - - - - - - - - - - - - P30.00/product b) periodic commodity clearance per product 1. one month - - - - - - - - - - - - - - - - P50.00 2. three months - - - - - - - - - - - - - - - - P100.00 3. six months - - - - - - - - - - - - - - - - P200.00 4. one year - - - - - - - - - - - - - - - - P400.00 Section 9 – The Food and Drug Administration shall not issue any commodity clearance for product not under its jurisdiction as listed in Rule IV, PD 930, except when the importing agency specifically requires such clearance. Section 10 – All orders, regulations or guidelines or parts thereof in conflict with the provisions of this order are hereby amended accordingly. Section 11 – This Order shall take effect immediately upon approval. Recommended by: (Sgd) ARSENIO M. REGALA, Ph.D. Administrator Approved: (Sgd) J.C. AZURIN Minister of Health