Philippine FDA: Guidelines for Importation and Exportation of Finished Drug Products & Raw Materials
Last Friday (26 May 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines for the Importation and Exportation of Finished Drug Products and Raw Materials".
The guidance aims to achieve the following:
Provide detailed guidelines and clear procedures in the issuance of Clearance for Customs Release (CFCR) for finished drug products and raw materials.
Conduct inspection of entry/exit ports authorized by the Bureau of Customs (BOC) for finished drug products and raw materials.
The guidance outlines the requirements, procedures, fees, and sanctions for importing and exporting drug products and raw materials in the Philippines. It also specifies the roles and responsibilities of the FDA, importers, exporters, customs brokers, and other stakeholders involved in the process.
The guidance requires importers and exporters of finished drug products and raw materials to secure a License to Operate (LTO) from the FDA and a Certificate of Product Registration (CPR) for each product they intend to import or export.
The guidance also details on the requirements from importers and exporters to apply for an Import Permit (IP) or Export Permit (EP) for each shipment of finished drug products and raw materials. The document provides a list of documents that must be submitted along with the application for IP or EP, such as commercial invoice, packing list, bill of lading, certificate of analysis, certificate of origin, etc.
Annex B provides guidance on CFCR using FDA eServices Portal System and Annex C describes procedures for using FDA eServices Portal System for CFCR.
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