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On May 26, 2022, Philippines FDA opened the comment period for the draft of Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017 (hereafter Guidelines) till June 2, 2022. The Guidelines shall take effect 15 days after its official publication.
Major Content
Application scope
The Guidelines covers manufacturers, traders and distributors (importers, exporters and wholesalers) of all processed food products, food supplements, raw materials, ingredients and additives for food, except salt, bottled water and heated tobacco products.
Objectives
To reengineer and streamline FDA’s processes and automate its system for initial, renewal, and variation application for License to Operate (LTO) through FDA’s available electronic systems;
To identify the documentary requirements for pre-license application, in addition to other technical requirements that shall be followed during the inspection for certain FDA regulated establishments.
General guidelines
All establishments, whether public or private entity, engaged in business or operation on food products shall first secure a LTO issued by FDA and, when applicable, product market authorizations, i.e., Certificate of Product Registration (CPR), before engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship activities.
FDA shall have the authority to enter any FDA-licensed establishments and establishments selling FDA-regulated food products during operating hours to conduct routine or spot check inspections.
Establishments shall bear the responsibility of ensuring the safety, efficacy, quality and/or purity of food products and comply to applicable standards, such as Good Manufacturing Practices (GRP), Good Distribution and Storage Practices (GDSP), and food safety standards recognized by the Food and Agriculture Organization of the World Health Organization.
Specific guidelines
The Guidelines provides the specific material requirements when applying for initial, renewal and variation of LTO, respectively. Additionally, food establishments need to submit franchise agreement and contract of agreement for initial application. Besides, for medium and large food manufacturers, they may be required to also provide Risk Management Plan (RMP) when applying for LTO or for major variations.
Procedures for LTO application are also specified, including the filling of application online, payment, evaluation and inspection process, checking of application status, as well as the releasing of LTO.
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