After acquiring a valid License to Operate, you may start the registration of your products to the Philippine FDA. The products to be marketed or to be manufactured may be classified as one of the following:
Over-the-counter (OTC) Drug
Based on the classification of your product, you will be required to submit technical requirements, certificates of analysis, stability testing, as well as proposed product labels, agreement contracts with parties involved in your operations; like toll manufacturers and suppliers of raw materials. Food and Drug Administration may require additional supporting documents regarding the product applying for CPR.
Product registration starts with the assessment and evaluation of the documents and technical requirements of your product to the Public Assistance Information & Compliance Section (PAICS) or to the Product Services Division (PSD), depending on the classification of the product applied for.
After the preliminary evaluation of the technical documents, the PAICS or the PSD will issue an assessment slip, wherein the amount to be paid for the application is also indicated. This assessment slip will be presented to the accounting division. You will be given and Order of Payment and will be requested to pay the amount indicated to the Cashier.
After the payment, the applicant will proceed to the PAICS for the submission of requirements. The applicant must have a copy of all the documents submitted filed in a folder that will serve as a receiving copy. Keep also in mind that documents submitted in photocopy should be supported with the original copy upon request of the evaluating officer. Upon submitting the documents, the applicant will be given a Routing Slip Number (RSN). The RSN will be written on the receiving copy, the RSN is used to verify the status of the application, to follow-up and inquire about the updates of the application. A follow-up can only be made 3 months after the application for the Certificate of Product Registration has been filed. Also keep your RSN always on hand; this is the only reference number that could trace the status of your application.
On initial follow-up, you may be given a Certificate of Product Registration (CPR), a Letter of Denial (LOD) or a Notice of Deficiency (NOD). There are very few cases that FDA denies an application, or issues a CPR right away. Usually, upon initial follow-up, the applicant receives an NOD. The reason for this is because the one that conducted the preliminary assessment of the requirements during the receiving is different from the one who will conduct the thorough evaluation of the technical requirements. Itís up to the evaluating officerís discretion to notify deficiencies, approve or deny the product registration.
If the application has been approved, it will be forwarded to the Chief of the Product Services Division for signatory, then to the Office of the Director also for signatory. On the event that the Office of the Director finds irregularities or deficiencies on your product registration, the Office of the Director may again deny your application, or issue a Notice of Deficiency.
If an applicant receives a notice of deficiency, all he has to do is to comply the requested documents by the Philippine FDA. Compliance should be made within thirty (30) days after receiving the notice of deficiency. If the applicant fails to comply within the said thirty (30) days, the application will be considered as an initial registration, and start the process all over again.
A Certificate of Product Registration is the certificate issued by the Bureau of Food and Drugs/ Philippine FDA (Food and Drug Administration) for the purpose of marketing and free distribution of a product after evaluation and of its safety, efficacy and quality.
Only after a CPR has been secured, the Applicant Company or individual can proceed with product marketing, selling and distribution, considering that these activities are limited by their License to Operate.
Also remember that CPRís are not stand-alone certificates, each CPR is owned by a particular company/proprietor having a duly registered LTO.
By: Rovie Ray Roldan RPhd.
Address: 6F Salustiana D. Ty
104 Paseo De Roxas, Legaspi Village
1209 Makati City, PHILIPPINES
Tel: +63 2 5538841,
+63 2 5538842,
+63 905 3130064.
Fax: +63 2 5530874.
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