Certificate of Product Registration

Pharmacy

Before a company’s products are allowed entry into the Philippine market, each of these products must undergo separate product registration processes. Depending on the classification of the products to be marketed (food, food supplement, drug, cosmetic, household hazardous, pesticides, medical device, diagnostics or veterinary products), there are vastly different registration requirements and respective processing timelines.

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Requirements:

• Accomplished and duly notarized application forms No.1 and No.8;
• Copy of valid contract between manufacturer and trader/distributor/seller/exporter/importer;
• Copies of valid LTOs for manufacturer/trader/distributor/seller/exporter/importer;
• Unit dose and batch formulation (in metric system);
• Technical specifications on all raw materials;
• Certificate of Analysis on raw materials and finished product from manufacturer;
• Technical specifications of finished product;
• Master manufacturing procedure, poduction equipment, sampling and in-process controls;
• Assay on test procedures and data analysis (if applicable);
• Stability study in accordance with the Philippine national guidelines and ASEAN guidelines;
• Representative sample of packaging and labeling materials for commercial market;
• Copy of ACB approval; and
• Copy of the original Product Registration in the manufacturing country (for foreign manufactured products).

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Procedure:

• Submit application and all requirements to Public Assistance Information and Compliance Section of FDA for assessment;
• Proceed to Accounting and Billing Department to have registration fees assesed and paid for;
• Obtain endorsement for Certificate of Registration after evaluation of Product Services Division; and
• Secure signed Certificate of Registration and Product Registration documents from FDA.

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