|Updated Guidelines for the Implementation of the ACD|
|Philippines Food and Drug Administration|
|Main Supporting Rules|
|1 Sep 2015||Cosmetic e-Notification v.2.0 Booklet for Applicants|
|1 Mar 2016||Guidelines on the Unified Licensing Requirements and Procedures of the FDA|
In the Philippines, the Food and Drug Administration (FDA) (formerly the Bureau of Food and Drugs) created under the Department of Health, is responsible for regulating cosmetic products and ensuring the safety, purity, and quality of cosmetics in Philippines market. Being a prominent member of ASEAN, Philippines formally adopted the ASEAN Harmonized Regulatory Scheme and the ASEAN Common Technical Documents into the National Requirements on April 2005 and allowed the cosmetic industry a transitory period to 31 Dec 2007. Since then, a notification scheme has been implemented in Philippines.
All cosmetic companies shall obtain a License to Operate (LTO) prior to engaging in manufacturing, importation, distribution and sale of cosmetics. The LTO is also an essential requirement to be able to notify cosmetic products. All companies are asked to ensure that their notified products meet the requirements of the ASEAN cosmetic Directive, its annexes and appendices.
|Guidelines on the Unified Licensing Requirements and Procedures of the FDA||2016-03-01||In force|
|ASEAN Cosmetic Directive||2003-09-02||In force|
The main competent department for the regulation of cosmetic products is the Center for Cosmetics Regulation and Research (CCRR), which belongs to the Philippines FDA and has 2 sub-branches, the Licensing and Registration Division and the Product Research and Standard Development Division.
The definition of cosmetic product is the one contained in the Asean Cosmetics Directive: "Any substance or preparation intended to be placed in contact with the external parts of the human body... or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance , and/or correcting body odours and/or protecting or keeping them in good condition".
The requirements for manufacturing cosmetics in the respects of personnel, Premises, equipment, Sanitation and hygiene, and others are set by the ASEAN guidelines on Good Manufacturing Practice (GMP). Cosmetic manufacturers must ensure that their manufacturing conditions comply with the GMP.
All cosmetic establishments shall ﬁrst secure the LTO or authorization from FDA prior to engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertisement and for sponsorship of any activity that involves cosmetics. They must continuously comply with the existing requirements, regulations and standards and under the supervision of a qualiﬁed person as required by the regulations. The responsibility of ensuring the safety, quality, and when applicable, the efficacy and/or purity of health products, shall rest upon all the establishments or persons involved in the production, sale, handling, packing, transport, distribution, trading and storage thereof.
All licensed manufacturers are granted an Initial LTO based on the minimum requirements set by FDA in order to operate a manufacturing plant. A Certificate of GMP Compliance shall only be issued upon demonstration of satisfactory compliance to GMP and effective up to the validity of the current LTO. Thereafter, the Certiﬁcate of GMP Compliance shall be issued each time the LTO is renewed.
a) Initial Application
- Accomplished Application Form and Declaration and Undertaking
- Proof of Business Name Registration
- Site Master File (for manufacturers of drugs, devices and cosmetics)
- Risk Management Plan
b) Renewal Application
- Accomplished Application Form with Declaration and Undertaking
An application for LTO, whether initial, renewal, or variation, and other authorizations are deemed ﬁled upon submission of complete requirements including payment of required fees and charges.
The evaluation of all applications for LTO shall be based on the veracity of the submitted documents and compliance with appropriate standards.
In case the applicant falsiﬁed, misrepresented material facts or documents, or withheld any material data or information, the application shall be disapproved. In such cases, the applicant may be investigated, appropriate charges may be ﬁled, and penalties may be imposed.