Revised Guidelines in Licensing Cosmetic Establishments

February 4, 2013

FDA CIRCULAR NO. 002-13

 

Consistent and consonance with the provisions of RA 9711 and its implementing rules and regulations, the FDA hereby set the revised rules and regulations in licensing cosmetic establishments that would engage their business here in the Philippines:

(1) All establishments that will engage in cosmetics manufacture, trader, distributor shall secure appropriate licenses in accordance to the existing rules and regulations set by FDA.

(2) Institute their own regulatory mechanism, aligned with ASEAN Cosmetic Directive (ACD), in ensuring the quality, efficacy and safety of all cosmetic products in the market.

(3) For renewal and amendments of the license, all cosmetic establishments shall surrender their license to operate to reflect changes in the format, text and signatory in the revised LTO.

(4) Cosmetic traders who does not own the cosmetic product formulation but owns the cosmetic brand shall be re-classified as COSMETIC DISTRIBUTOR.

(5) The person (natural or juridical) placing the product in the Philippine market shall be regarded as the product owner, whether manufacturer, trader or distributor. Thus, the ownership of the formulation of a cosmetic product must be determined and explicitly stated in the manufacturing or distributorship agreement. TEHDIA

(6) In that, the Product Information File (PIF) must be updated and accessible during inspection.

(7) All cosmetic establishments are required to renew at least three months before expiration of the LTO. Strictly adhere to the schedule of submission business transaction of LTO and CPR.

(8) The FDA and the company shall use the revised checklist of requirements and licensing forms for Cosmetics. (see Annex)

This guideline shall take effect immediately after posting in the FDA website.

(SGD.) KENNETH Y. HARTIGAN-GO, MDActing Director IV

ATTACHMENT

Joint Affidavit of Undertaking

Center for Cosmetics Regulation and Research

CENTER FOR COSMETICS REGULATION AND RESEARCH

Checklist of Requirements for Cosmetic Establishments

I. General Requirements

[ ] Notarized Accomplished Petition Form with 2 x 2 ID picture of Owner/Incorporator/Authorized Representative aSATHE

o Secretary's Certificate/Special Power of Attorney for authorized representative

[ ] Notarized Joint Affidavit of Undertaking with 2 x 2 ID picture of Authorized Person

[ ] For Authorized Person (Pharmacist/Allied Health Science Profession), copy of the following:

o Board Certificate

o Valid PRC ID

o Current PTR

o Signed Duties and Responsibilities

o Certificate of Attendance to a FDA sponsored seminar on licensing of establishments or promissory letter to attend

[ ] Proof of Business Registration

o If Single Proprietorship, Valid Certificate of Business Name Registration with the Department of Trade and Industry (DTI)

o If Corporation or Partnership, Valid Registration with SEC and Articles of Incorporation and other pertinent documents

o If the Business Name is different from the Corporate Name, SEC Certificate must reflect "Doing Business under the name and style of . . . (Name of Establishment)"

o If Cooperative, Certificate of Cooperative Development Authority (CDA)

o Valid Mayor's Business Permit/Barangay Business Permit, if the business name and address is different from the registered name and address in the DTI or SEC

o For Change of Ownership: Deed of Sale

o For Merging/Buy-out: Deed of Assignment

[ ] Proof of Occupancy

o Notarized valid Contract of Lease/Sublease (if the space/building being occupied is not owned)

o Transfer Certificate of Title (if owned) AHDTIE

o Notarized Certificate of Occupancy (if owned by one of the incorporators)

o Valid Homeowner's Association (HOA) Clearance if the establishment is located inside a subdivision or residential condominium

o Floor plan, vicinity map and picture with signage

II. Specific Requirements

A. For Distributor:

[ ] List of Products distributed in matrix format indicating the name of raw material and/or product, manufacturer, supplier/trader, complete address

[ ] For Raw Material Distributor, submit Safety Data Sheet (SDS) with complete data

[ ] Proof of Occupancy — Warehouse

o Notarized valid Contract of Lease/Sublease (if warehouse being occupied is not owned)

o Transfer Certificate of Title (if owned)

o Notarized Certificate of Occupancy (if owned by one of the incorporators)

o Valid Homeowner's Association (HOA) Clearance if the establishment is located inside a subdivision or residential condominium

o Notarized valid Warehousing Agreement (Third Party Logistics)

o Floor plan, vicinity map and picture with signage

(1) For Importer

[ ] Valid Foreign Agency Agreement from each supplier duly authenticated by the Territorial Philippine Consulate

• Additional Requirement, if the supplier is not the manufacturer: aSTAIH

o Valid Supply Agreement between the foreign source and manufacturer or

o Valid Tripartite Agreement duly Authenticated by the Territorial Philippine Consulate

[ ] Valid GMP Certificate of manufacturer issued by the government agency or accredited business association in the country of origin or self-declaration of compliance to GMP (ASEAN, ECC/EU, COLIPA)

• For raw materials, an ISO/Business License/Manufacturer's License may be submitted in lieu of GMP Certificate

(2) For Exporter

[ ] Notarized valid distribution agreement with FDA-licensed Supplier (Manufacturer/Distributor/Trader) indicating the countries where the products are to be exported

[ ] Valid License to Operate of the Manufacturer/Distributor/Trader

[ ] List of Products with notification numbers and validity

(3) For Wholesaler

[ ] Notarized valid distribution agreement with FDA-licensed Supplier (Manufacturer/Distributor/Trader)

[ ] Valid License to Operate (LTO) of the Manufacturer/Distributor/Trader

[ ] List of Products with notification numbers and validity

B. For Trader:

[ ] List of products manufactured by toll manufacturer

[ ] Copy of Notarized Manufacturing Agreement stipulating the ownership of formulation and the joint responsibility of the manufacturer and trader in placing the product in the market aADSIc

[ ] Copy of notarized valid agreement with the third-party warehousing services, if any

[ ] Proof of Occupancy — Warehouse

o Notarized valid Contract of Lease/Sublease (if warehouse being occupied is not owned)

o Transfer Certificate of Title (if owned)

o Notarized Certificate of Occupancy (if owned by one of the incorporators)

o Valid Homeowner's Association (HOA) Clearance if the establishment is located inside a subdivision or residential condominium

o Notarized Warehousing Agreement (Third Party Logistics)

o Floor plan, vicinity map and picture with signage

C. For Manufacturer:

[ ] Letter of Intent for Pre-Site Inspection (Fee: 500.00)

[ ] After approval of pre-site inspection:

o Pre-Site Inspection Report

o Photocopy of the Financial Statement duly notarized/received by the Bureau of Internal Revenue (BIR); if not available submit notarized certification of initial capital invested.

o Location plan/Site (indicate size, location, immediate environment and type of building)

o Site Master File (See attached form)

o List of products to be manufactured in actual product dosage form (e.g., liquid/solution, gel, lotion, cream)

[ ] For Importer of Raw Materials/Finished Products in Bulk:

o Foreign Agency Agreement duly authenticated by the Territorial Philippine Consulate DICcTa

o Certificate of Status of Manufacturer (CGMP Certificate) issued by the Government Health Agency duly authenticated by the Territorial Philippine Consulate (for API, finished cosmetic product/s)

o Certificate of Analysis (Raw Materials and/or Finished Products in Bulk)

o Safety Data Sheet (SDS)

III. Schedule of Fees:

Licensing fees are based on A.O. 50 s. 2001

A. Distributor

1. Initial/Opening (LTO valid for 1 year) P3,000.00 + 1% Legal Research Fee (LRF) = Php3,030.00

2. Renewal (LTO valid for 2 years) P6,000.00 + 1% Legal Research Fee (LRF) = Php6,060.00

B. Manufacturer/Trader

1. Initial/Opening (LTO valid for 1 year)

Capital	Company	Corresponding
Investment	Classification	Fee/Year
(based on financial		(+ 1% Legal Research
statement)		Fee)
20 Million and	Cosmetic	Php5,000.00
below	Manufacturer	+ Php50.00
		––––––––––––
		= Php5,050.00
		=========
	Cosmetic	Php3,000.00
	Trader	+ Php30.00
		––––––––––––
		= Php3,030.00
		===========
Over 20 Million	Cosmetic	Php10,000.00
But Below 50	Manufacturer	+ Php100.00
Million		–––––––––––––
		= Php10,100.00
		============
	Cosmetic Trader	Php5,000.00
		+ Php50.00
		––––––––––––
		= Php5,050.00
		===========
50 Million and	Cosmetic	Php15,000.00
Above	Manufacturer	+ Php150.00
		–––––––––––––
		Php15,150.00
		============
	Cosmetic	Php7,000.00
	Trader	+ Php70.00
		––––––––––––
		= Php7,070.00
		===========

2. Renewal (LTO valid for 2 years) — corresponding fee/year (+ 1% LRF) x 2 years cDAITS

3. Changes in Circumstances — refers to changes in business name, business address, ownership and authorized person (Pharmacist/Allied Health Science Profession)

 Php500.00 + 1% Legal Research Fee = Php510.00

Note:

1. PLEASE BRING ORIGINAL DOCUMENTS FOR VERIFICATION UPON SUBMISSION OF APPLICATION

2. SUBMIT APPLICATION THROUGH ELECTRONIC COPY IN DVDR FORMAT AND HARD COPY

3. SUBMISSION OF APPLICATION IS EVERY FRIDAY FROM 7:00 AM TO 3:00 PM

4. INCOMPLETE DOCUMENTS WILL NOT BE ACCEPTED

5. IN CASE OF TURNED INITIAL APPLICATION/CHANGE OF OWNERSHIP/MERGING OR BUY-OUT, SURRENDER PREVIOUSLY ISSUED LTO (ORIGINAL)

6. PETITION FORM AND JOINT AFFIDAVIT WITH ERASURES WILL NOT BE ACCEPTED

Additional Activity (Importer, Exporter)

Toll Manufacturer, Packer, Repacker

• Letter of Request

• Original LTO

• Re-issuance fee of Php500.00 (based on A.O. 50 series of 2001)

• Other requirements, refer to particular specific business activity as stated in the general checklist of requirements

• Proof of payment

Change Ownership

• Letter of Request

• Deed of Sale or Transfer of Rights STIcEA

• Surrender Original LTO

• All the required documents applied for initial/opening

• Proof of payment

Change of Manufacturing Site

• Letter of request

• The case for change of site of a manufacturer follows the requirements for Opening/Initial application

• Surrender Original LTO

• Proof of payment

Change of Authorized Person (Pharmacist/Allied Health Science Profession)

• Letter of Request

• Resignation Letter noted by the employer

• Submit Notarized Joint Affidavit of Undertaking

• All requirements under the general requirements for Authorized Person

• Proof of payment

Schedule of fees for change of Circumstances/Amendment:

P500.00 + 1% (LRF) = P510.00

Change of Business Name

• Letter of Request

• Notarized Petition Form and Joint Affidavit of Undertaking

• Business Name Registration (DTI/SEC)

• Picture of Drugstore with Permanent Signboard

• White Generic Label EIcSTD

• Rubber Stamp

• Surrender Original LTO

• Proof of payment

Transfer of Location (Trader and Distributor)

• Letter of Request

• Business Name Registration (DTI/SEC) Reflecting the New Address

• Mayor's Permit or Brgy. Business Permit

• Contract of Lease/Proof of Ownership

• Floor Plan with Dimension

• Vicinity Map/Location Plan

• Surrender Original LTO

• Proof of payment

Addition/Deletion of Source

• Letter of Request

• Proof of cancellation/deletion of supplier/notarized termination agreement

• If in case addition of source, refer to the Checklist of Requirements

• Original LTO

• Proof of payment

Reconstruction/Lost/Dilapidated LTO

• Letter of Request

• Affidavit of Lost

• Proof of payment EcHTCD

In case of closure of business activity:

• Letter of request

• Surrender LTO

If lost, submit Affidavit of Lost