Revised Guidelines in Licensing Household Hazardous Substances (HHS) Establishments

March 6, 2013

FDA CIRCULAR NO. 009-13

 

Pursuant with the provisions of R.A. 9711 and its implementing rules and regulations, Presidential Decree 881 and Administrative Order 303, 1976, the FDA hereby set revised rules and regulations in licensing of HHS establishments that would engage their business here in the Philippines:

(1) All that will engage in manufacturing, trading, and distribution of Household Hazardous Substance (HHS) products shall secure appropriate licenses in accordance to the existing rules and regulations set by the FDA.

(2) All establishments shall institute their own regulatory mechanism, in ensuring the quality, efficacy and safety of all HHS products in the market.

(3) For renewal and amendments of the license, all HHS establishments shall surrender their license to operate to reflect changes in the format, text and signatory in the revised LTO. A fee of PhP500.00 + 1% LRF will be charged.

(4) HHS Distributors who owns the HHS product formulation and falls under the activity of trader as prescribed in the RA 9711, which is, "any establishment who is a registered owner of the health product and procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such product to a licensed manufacturer". In addition, a trader may also engage in the distribution and/or marketing of its products shall be re-classified as HOUSEHOLD HAZARDOUS SUBSTANCE TRADER. CTaIHE

(5) All HHS establishments are required to renew at least three (3) months before expiration of the LTO. Strictly adhere to the schedule of submission business transaction of LTO and CPR.

(6) The FDA and the establishments shall use the revised checklist of requirements and licensing forms for Household Hazardous Substance. (See Annex-I Checklist of Requirements for Household Hazardous Substances Establishments; Annex-II Petition Form and Annex-III Requirements for Changes in Circumstances).

(7) All amendments shall be coursed in the new FDA Circular.

This guideline shall take effect on 15 March 2013.

(SGD.) KENNETH Y. HARTIGAN-GO, MDActing Director IV Food and Drug Administration

ATTACHMENT

Center for Cosmetics Regulation and Research

Checklist of Requirements for Household Hazardous Substances Establishments

I. General Requirements

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

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

• Signed Duties and Responsibilities

• Certificate of Attendance to FDA sponsored seminar on licensing of establishment or promissory note to attend

[ ] Notarized Accomplished Petition Form

[ ] Proof of Business Registration

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

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

• 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)"

• If Cooperative, Certificate of Cooperative Development Authority (CDA) HAaScT

• 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

• For Change of Ownership: Deed of Sale

• For Merging/Buy-out: Deed of Assignment

[ ] Proof of Occupancy

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

• Transfer Certificate of Title (if owned)

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

• Valid and duly notarized Warehousing Agreement (Third Party Logistics)

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

• Floor plan, vicinity map and picture with signage

II. Specific Requirements

A. For Manufacturer

[ ] Pre-Site Inspection

• Letter of Intent indicating the intended products to be manufactured and location of the site with contact details

• Proof of payment (P510.00)

[ ] After Pre-site Inspection:

• Copy of Pre-Site Inspection Report

• 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 EDHTAI

• Accomplished Site Master File

• Clearance from Department of Environment and Natural Resources (DENR)

• List of personnel, technical and non-technical (indicate academic qualifications and relevant experience)

• List of products to be manufactured in actual product dosage from (e.g., liquid/solution, gel, lotion, aerosol spray)

• List of manufacturing and quality control facilities and equipment

[ ] For Repacker

• Floor plan with complete dimensions in meters and proper identification of areas with description

• Organizational Structure

• List of repacking and quality control facilities and equipment

• Photocopy of valid contract/agreement with the manufacturer stipulating that both the manufacturer and repacker are jointly responsible for the quality of the products

• Photocopy of License to Operate (LTO) of the Manufacturer

[ ] For Importer of Raw Materials (RM)/Finished Products (FP) in Bulk:

• Foreign Agency Agreement duly authenticated by the Territorial Philippine Consulate

• List of source(s) and RM/FP in bulk being imported

• Submit any of the following:

o ISO Certificate based on current ISO standards

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

o Safety Data Sheets (SDS) acCTSE

B. For Distributor:

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

[ ] Proof of Occupancy — Warehouse

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

• Transfer Certificate of Title (if owned)

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

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

• Valid and duly notarized Warehousing Agreement (Third Party Logistics)

• 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:

o Valid Supply Agreement between the foreign source and manufacturer

o Valid Tripartite Agreement duly Authenticated by the Territorial Philippine Consulate

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

(2) For Exporter

[ ] Duly notarized and 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 acHDTA

[ ] List of HHS products with registration numbers and validity

(3) For Wholesaler

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

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

[ ] List of HHS products with registration numbers and validity

III. Schedule of Fees:

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

A. Distributor

1. INITIAL/OPENING (1 year LTO validity)

 P3,000.00 + 1% Legal Research Fee = Php3,030.00

2. RENEWAL (2 years LTO validity)

 P6,000.00 + 1% Legal Research Fee = Php3,060.00

B. Manufacturer

1. INITIAL/OPENING (1 year LTO validity);

Capital	Company	Corresponding
Investment	Classification	Fee
(Based on Financial		(+ 1% Legal Research
Statement)		Fee)
1 Million and	HHS	Php1,000.00
below	Manufacturer/	+ Php10.00
	Repacker	––––––––––––
		= Php1,010.00
Over 1 Million	HHS Manufacturer/	Php2,000.00
But Below 5	Repacker	+ Php20.00
Million		––––––––––––
		= Php2,020.00
5 Million but	HHS Manufacturer/	Php3,000.00
below 10 Million	Repacker	+ Php30.00
		––––––––––––
		= Php3,030.00
10 Million but	HHS Manufacturer/	Php5,000.00
below 20 Million	Repacker	+ Php50.00
		––––––––––––
		= Php5,050.00
20 Million but	HHS Manufacturer/	Php10,000.00
below % 0 *	Repacker	+ Php100.00
Million		–––––––––––––
		= Php10,100.00
50 Million and	HHS Manufacturer/	Php15,000.00
Above	Repacker	+ Php150.00
		–––––––––––––
		= Php15,150.00

2. RENEWAL (2 years LTO validity) = Initial Fee x 2

C. Changes in Circumstances — refers to changes in business name, business address, ownership and authorized person (Pharmacist/Allied Health Science Profession) and also refers to any changes if activities as to the inclusion and or deletion of toll manufacturer(s), trader(s), source and/or name of source, products or activity aIHSEc

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

D. Amendments — refers to the inclusion and/or deletion of activity, product, source or client; it also encompasses corrections done on LTO, GMP Certificate, CPR or notification

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

Legend: * — minimum of P10.00 LRF if amount to be payed is below P1,000.00

NOTE:

1. STRICTLY FOLLOW PROCEDURES IN ACCORDANCE TO FDA MEMORANDUM CIRCULAR 2013-001 "Guidelines on the Submission of Company Applications and Product Dossiers in Electronic Copy".

2. IN CASES OF APPLICATIONS TURNED INITIAL, CHANGE OF OWNERSHIP, MERGING OR BUY-OUT, SURRENDER PREVIOUSLY ISSUED LTO (ORIGINAL).

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

Center for Cosmetics Regulation and Research