Overview
On August 18, 2009, FDA Philippines came up with a new law strengthening the Regulatory capacity of the Bureau of Food and Drugs (BFAD) to ensure the safety, quality, and efficacy of medicines and other health products. The Philippines nutritional supplements market is driven by robust demand for herbal supplements and is fully regulated under the food requirement for FDA Philippines. As per Administrative Order No. 37 s. 1979, imported food products are required to be registered with BFAD prior to their distribution in the domestic market (Philippines).
License to Operate (LTO) - the importer is required to obtain from the exporter and should be authenticated by the Philippines Consulate in the country of origin. A local company in the Philippines must secure a License to Operate (LTO) from the Bureau of Food and Drugs (BFAD) before applying for product registration.
The nutraceuticals market of the Philippines is presently in its early growth stage due to the dependence on the traditional pharmaceutical medicine system by the growing middle-class population. The Philippines’ nutraceutical market basically can be divided into three (03) major categories:
- Vitamins and Dietary Supplements
- Functional Beverages
- Functional Foods
Freyr recommends that the companies operating in the nutraceuticals market can expand their market share to the Philippines and increase revenue generated by focusing on product innovations for vitamins and dietary supplements, launching new flavor variants for functional foods and beverages, and undertaking online channels of distribution for their products. Freyr assists manufacturers to enter the Philippine market complying with FDA Philippines regulations.
Freyr Expertise
- Classification of Functional Foods
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Product Registration
- Dossier Compilation and Submission to the FDA Philippines
- Legal Representation
- License Holding Support
- Regulatory Intelligence Report
- New Ingredient Registration
- License to Operate (LTO) Support
ADVANTAGES
Freyr Advantages
End-to-end Regulatory consultation for Philippines
Total Registration Support with Legal Representation and LTO
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
Support for region-specific Regulatory activities
Extensive partner network across the globe
Strong relationship with different Health Authorities