Basic information
Outline of the system
The Food and Drug Administration (FDA) licensing system includes licensing and inspection processes for manufacturers, traders, and distributors of health products. The application system for the licensing process is fully online. Applications for the license of establishments handling cosmetics and household urban hazardous substances are processed by the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR). The licensing system aims to determine an establishment's compliance with administrative and technical requirements on the manufacture and distribution of cosmetics and household urban hazardous substances prior to engaging in the activity (pre-licensing) and during the validity of the license (post-marketing surveillance).
Product coverage
Applications for the license of establishments handling cosmetics and household urban hazardous substances are processed by FDA-CCHUHSRR through the FDA e-Portal System. The licensing system covers establishments engaged in the manufacture, importation, exportation, trade, and distribution of cosmetics and household urban hazardous substance (including household urban pesticides and toys and childcare articles).
Nature of licensing
Automatic
If Automatic, administrative purpose
Automatic licensing to protect human, animal or plant life and health; protect environment
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
There are no limits set on the quantity or value of imported products which are intended to be placed in local trade, provided that such products are registered with the FDA and that the importer is duly-licensed with the FDA.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
The licensing system applies for locally and foreign-manufactured products that are intended to be placed in the Philippine market.
Expected duration of licensing procedure
Ongoing
Legal requirements
Is the licensing statutorily required?
The licensing system implemented by the FDA is based on Republic Act No. 9711 otherwise known as the 'FDA Act of 2009' and its Implementing Rules and Regulations, where the licensing of establishments and the registration of health products under the jurisdiction of the FDA is statutorily required.
Procedural guidelines for the licensing application system are provided in DOH Administrative Order No. 2020-0017. Technical standards for cosmetics and household urban hazardous substances are provided in DOH Administrative Order No. 2020-0015, FDA Circular No. 2013-002, FDA Memorandum Circular No. 2015-011, FDA Circular No. 2020-025, DOH Administrative Order No. 2019-0008, FDA Circular No. 2015-002, and their amendments.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
All entities allowable to engage in business in the Philippines may apply for a license with the FDA, provided that administrative and technical requirements can be sufficiently satisfied by the applicant.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Food and Drug Administration
Address
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City, Philippines
Telephone
(+632) 8821-1176
Fax
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Food and Drug Administration
Documentation requirements
What information is required in applications?
Procedural guidelines for the licensing application system are provided in DOH Administrative Order No. 2020-0017. Technical standards for cosmetics and household urban hazardous substances are provided in DOH Administrative Order No. 2020-0015, FDA Circular No. 2013-002, FDA Memorandum Circular No. 2015-011, FDA Circular No. 2020-025, DOH Administrative Order No. 2019-0008, FDA Circular No. 2015-002, and their amendments.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
An establishment intending to engage in the importation of a cosmetic product or household urban hazardous substance must consider the processing timelines provided in the agency Citizen's Charter in securing the necessary authorizations.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Applications for establishment licenses and product authorizations are received year-round, during usual business operating hours.
Issuing the license
Can a licence be granted immediately on request?
As a general rule, applications are processed following the timelines provided in the FDA Citizen's Charter.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The processing timelines for an importer license is 20 to 40 working days, while the processing timelines for a product authorization is 17 to 40 working days.
Which administrative body is responsible for approving application of licences?
The processing and approval of licenses and product authorizations issued by the FDA for the establishments and products under its jurisdiction are conducted solely by the FDA.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
Continuous compliance to existing rules, regulations, and standards is monitored by the FDA through post-marketing surveillance activities. Failure to demonstrate continuous compliance as a condition of its authorization may be a ground for the disapproval of an application and suspension or cancellation of an authorization.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Yes
What is the amount of the fee or charge?
Fees and charges are provided under DOH Administrative Order No. 50 s. 2001.
Is there any deposit or advance payment required associated with the issue of licences?
Not applicable.
Please refer to https://www.fda.gov.ph for further information.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
The grounds for disapproval include: a) application requirements submitted show that the establishment does not meet the required technical requirements or appropriate standards, b) applicant made misrepresentations, false entries, or withheld any relevant data contrary to the provisions of the law or appropriate standards, c) owner has violated any of the terms and conditions of its license, and d) other analogous grounds or causes as determined by the FDA.
Are the reasons for any refusal given to applicants?
Such grounds are communicated officially to the applicant when an application is disapproved.
Have applicants a right of appeal in the event of refusal to issue a licence?
A disapproval of an application is made without prejudice to the filing of a new application if the grounds or basis of disapproval of the original application no longer exists.
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
Applications for establishment licenses and product authorizations are received year-round, during usual business operating hours.
What documents are required upon actual importation?
A valid License to Operate and a Certificate of Product Registration/Notification are required.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Regulations of the Bureau of Customs and the Bureau of Quarantine are separately promulgated by the said agencies.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
An initial license is given a 1-year validity for cosmetic establishments 3-year validity for household urban hazardous substances establishments, while renewals are given a 2-year validity for cosmetic establishments and a 5-year validity for household urban hazardous substances establishments.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
If the holder or owner of the product authorization, without legitimate reason fails to sell the health product or fails to cause it to be marketed during an uninterrupted period of at least three years from date of issuance or renewal of the registration or the last date of operation or marketing can be held as grounds for the disapproval of an application and suspension or cancellation of an authorization.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Certain conditions apply for changes to the particulars of a license otherwise termed as variations, where amendments to the license are required for such change to be deemed acceptable. Allowable variations and the necessary requirements are provided in DOH Administrative Order No. 2020-0017.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Regulations of the Department of Finance, Bureau of Internal Revenue, Bureau of Customs, and Bangko Sentral ng Pilipinas are separately promulgated by the said agencies.