On March 30, 2023, the Philippines FDA released a draft document titled "Rules and Guidelines on the Issuance of Import Permit as ‘Samples Only’ for FDA Regulated Products Intended for Research and Development Purposes". All comments can be submitted to rcferrer@fda.gov.ph with copy furnish to gapascual@fda.gov.ph on before 12 April 2023.
Background
The Philippines requires food establishments to secure Import Permit before importing prepackaged processed food products, bulk foods, and raw materials intended to be used as samples for research and development purposes. The Import Permit shall be valid for 90 days from the date of its issuance and shall be used for only once. The draft provides guidance on obtaining Import Permit as "Samples Only" from the Philippines FDA.
Scope
The proposed draft applies to food establishments with a License to Operate as Food Importer that are involved in food manufacturing for their own use, food traders having contracts with a toll manufacturer, and food distributors/wholesalers importing food samples for research and development purposes. Importantly, the draft does not cover importation of products for use in exhibitions and trade shows. Besides, imported food products intended for research and development are prohibited from market testing or for display in any commercial facilities, trial run or actual selling. In the Philippines, Market testing is regulated under Ads and Promotion Permit.
The maximum limit for different kinds of imported products intended as samples is as follows:
a. Raw Materials: 50 kg or 50L
b. Acceptable Food Additives: 5 kg or 5L
c. Finished Products: 50 kg per variant / item and per invoice.
d. Food Supplements: 5 kg per variant (in form of capsule, powder or tablets) and per invoice.
Application Guidelines
Food establishments shall apply for import permit at least 14 days before the arrival of product samples by submitting the application through email to fdac.letters@fda.gov.ph. The application will go through a pre-assessment and a formal evaluation. If the applicant fails to meet the requirements for import permit issuance, a Letter of Disapproval (LOD) shall be issued following a compliance period of seven calendar days.
Details of application requirements can be viewed at Annex A, including the required information (e.g., product name, brand name, lot number, quantity and manufacturer), and the required documents (e.g., notarized affidavit of undertaking, COA, invoice and LTO).
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