HOW TO REGISTER A PRODUCT TO FDA;

o apply for a certificate of product registration, you will need to prepare the following:

Application form

Valid license to operate from the FDA

 Product labels. You must provide copies of the product’s labels in all packaging sizes. You
must also include photos of the product in all packaging sizes from different angles. You must
also include supporting documentation for logos/seals per labeling regulations. For example,
Halal or Sangkap Pinoy.
 Product documents. The documents must support any product claims. You must also
include documents detailing physicochemical and microbiological specifications.
 Certificate of analysis. This document must contain important details about the product.
The information must be relevant to compliance with food standards and regulations.
 Product sample. You must also provide an actual representative product sample. Your
sample must appear as it would commercially and complete with all labels.

Submit an application for product registration through FDA Électronic Portal for pre-assessment

Requirements for processing my Certificate of Product Registration from the Food

and Drug Administration (FDA)?
 Accomplished and duly notarized application forms;
 Actual representative product sample of food supplement (for initial applications);
 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 the manufacturer;
 Technical specifications of finished product;
 Copy of the original Product Registration in the manufacturing country (for foreign
manufactured products).

What are the procedures for processing my FDA Certificate of Product Registration?
 Submit an application for product registration through FDA Électronic Portal for pre-assessment;
 If the application passes the pre-assessment, FDA will issue an Order of Payment.
 Pay the corresponding registration. Once the FDA cashier posts the payment, the next step will
be the evaluation.
 If the application is approved, FDA will send an e-mail stating how and where to download the
Certificate of Product Registration.
 Obtain endorsement for Certificate of Registration after evaluation of Product Services Division.
 3 MONTHS PROCESS
 CERTIFICATE OF BUSINESS FOR INITIAL APPLICATION
 ACOMPLISHED APPLICATION FORM DELIBARATION
 PROOF OF BUSINESS NAME REGISTRATION
 SITE MASTER

As a regulatory agency under the Department of Health, the Food and Drug
Administration, created under Republic Act No. 3720, series of 1963, as
amended by Executive Order 175, series of 1987, otherwise known as the
“Food, Drugs and Devices, and Cosmetics Act”, and subsequently Republic
Act No.

How to Get a License to Operate from the FDA in the Philippines

1. Petition form. ...

2. Joint Affidavit of Undertaking. ...
3. Certificate of Attendance to an FDA-sponsored seminar on licensing of establishments. ...
4. Proof of business registration. ...
5. Proof of occupancy or business address. ...
6. Floor plan and vicinity map.

How to register product to FDA Philippines?

1. What are the procedures for processing my FDA Certificate of Product Registration?
2. Submit an application for product registration through FDA Électronic Portal for pre-assessment;
3. If the application passes the pre-assessment, FDA will issue an Order of Payment.
4. Pay the corresponding registration.

How to Get an FDA Certificate of Product Registration in the Philippines

 Application form.
 Valid license to operate from the FDA.
 Product labels. You must provide copies of the product's labels in all packaging sizes. ...
 Product documents. ...
 Certificate of analysis. ...
 Product sample.