All pharmaceutical products before they can be imported, exported, distributed or sold in the Philippine market must be registered with the Bureau of Food and Drugs.

General requirements:

1. Valid License to Operate as a manufacturer, distributor (importer or exporter), or trader issued by the BFAD;

2. Brand name clearance from the BFAD. (For branded products only)

3. Duly notarized application for product registration.

4. Duly accomplished BFAD Form No.8 (Checklist).

5. Technical documents (Shelf Life Data Analysis, Product Specifications, sample labels or art works, etc., as contained in the checklist issued by the BFAD), sample product with corresponding certificate of analysis.

6. Certificate of Pharmaceutical Product (from country of origin if product is imported)