6. Registration Processes

Food Supplements
Philippines

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

N/A

6.2 Product Registration

“Foods supplements” should comply with Section 6.2 of the “General Foods” guidebook for the Philippines. 

Additionally, the below applies: 

As per Administrative Order 2010-0008 [1], no person shall advertise, promote, or use in any sponsorship any food/dietary supplements unless such product is duly registered and approved by the Food and Drug Administration.

Estimated cost and duration

For imported food supplements [2, 3, 4]: 

• Application fee: 20,000 Pesos
• Annual fee: 5000 Pesos (The Annual Fee shall be collected yearly upon issuance of the marketing authorization. Non-payment of the Annual Fee shall lead to the revocation of the marketing authorization.)
• Amendment: 2500 Pesos

The issuance of a Certificate of Product Registration (CPR) shall be based on compliance of the products with the applicable standards, requirements, and regulations. 

If the product does not conform to applicable standards, requirements, or regulations, a Letter of Denial shall be issued. The applicant shall be given 6 months to reapply by submitting the deficiencies and the complete set of documents. Otherwise, the application is considered initial. 

The timeline given for the processing of the CPR is ninety (90) days. This is considering that all the documents submitted are in compliance with the requirements. In cases of deficiencies issued to the company, the counting of the timeline stops and will resume only upon submission of the compliance documents.

6.3 Other Notes or Requirements

Please refer to Section 4.7 of the General Foods guidebook for the Philippines.

6.4 Manufacturing Site Registration

There are no manufacturing site registration requirements specific to “Foods supplements”. It should comply with Section 6.4 of the “General Foods” guidebook for the Philippines. 

6.4.1 Standard/Rules for Manufacturing Site [9]

There are no rules for manufacturing sites specific to “Foods supplements”. It should comply with Section 6.4.1 of the “General Foods” guidebook for the Philippines.

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

N/A

6.5 References

1. Administrative Order 2010-0008

https://www.fda.gov.ph/wp-content/uploads/2021/08/Administrative-Order-No.-2010-0008.pdf

2. Administrative Order No. 2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and the Other Food Products, and for Other Purposes

https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2014-0029.pdf

3. General Regulatory fees and charges

https://www.fda.gov.ph/wp-content/uploads/2018/06/FINAL-ANNEXES-for-AO-on-INCREASE-OF-FEES.pdf

4. Philippines DOH FAQ 

https://doh.gov.ph/faqs/How-many-days-will-it-take-for-the-processing-of-the-certificate-of-product-registration