1st DRAFT

Administrative Order

No.: ______________

Subject: Revised Rules and Regulations on the Licensing of

Establishments Engaged in the Manufacture and/or

Distribution; Registration or Other Authorizations; and

Labeling of Household/Urban Hazardous Substances

I. BACKGROUND AND RATIONALE

The regulation over hazardous substances has been established since 30 January

1976 through Presidential Decree No. 881 entitled, “Empowering The Secretary of

Health to Regulate the Labeling, Sale and Distribution of Hazardous Substances”.

Pursuant thereto, the Secretary of Health then issued Administrative Order 303 s.

1976 to set the rules and regulations for the registration of hazardous substances and

establishments engaged in the manufacture of hazardous substances.

On 17 January 1977, the Secretary of Health issued Administrative Order 311

prescribing the labeling requirements of hazardous substances and Administrative

Order No. 312 classifying substances which are hazardous in nature into five

categories. These categories are Category I – Product contacting Petroleum

Distillates, Category II – Polishes and Waxes, Category III – Cleanser and Detergent,

Category IV – Do-It-Yourself and Hobby Items, and Category V – Yard and Home

Products.

The regulation of hazardous substances by the Department of Health, through the

Food and Drug Administration, was carried and reiterated under Republic Act No.

7394 or the “Consumer Act of the Philippines” where, later on, such regulation and

control over Household/Urban Hazardous Substances was expressly vested directly

to the FDA through the Center for Cosmetics Regulation and Research pursuant to

Republic Act No. 9711 or the “Food and Drug Administration (FDA) Act of 2009”.

On 6 March 2013, the FDA issued FDA Circular 2013-009 entitled, “Revised

Guidelines in Licensing Household/Urban Hazardous Substance (H/UHS)

Establishments”, setting out the licensing requirements for all establishments

engaged in the manufacture, trade, and distribution of H/UHS products. In the

interest of efficient public service delivery, the FDA further amended the circular

with FDA Circular 2013-009-A dated 16 June 2014 by revising the licensing

requirements.

Presidential Decree No. 881 was adopted as an appropriate measure designed to

protect the people against other hazards to their health and safety. Republic Act No.

9711 ensures the FDA's monitoring and regulatory coverage over establishments and

products under its jurisdiction. The latter law expressly provides that household

hazardous substances is within the regulatory jurisdiction of FDA and requires the

registration of such products and licensing of establishments manufacturing and

distributing the same.

Hence, this Order is issued consistent with the provisions of the aforesaid laws

and in the interest of ensuring monitoring and regulatory coverage and providing

coherence in the FDA’s regulatory system for establishments and products under its

jurisdiction.

II. OBJECTIVES

This Administrative Order is created with the main objective to protect and

promote the right to health of the people and help establish and maintain an effective

regulatory system by regulating the establishments’ activities and covered products

requiring them to secure market authorizations prior to its operation. Specifically,

this Administrative Order has the following objectives:

1. To establish rules and regulations on the licensing of establishments engaged

in the manufacture and distribution; registration or other authorizations such

as but not limited to advertising and promotion; post-marketing surveillance;

and labeling of household/urban hazardous substances,

2. To prescribe to establishments the institution of their own regulatory

mechanism in ensuring the quality, efficacy and safety of all H/UHS

products,

3. To ensure compliance of establishments to national and international

standards and requirements of the following, but not limited to, Good

Distribution Practice (GDP), and Good Storage Practice (GSP); and

4. To prescribe the use and implementation of innovations, such as but not

limited to, electronic data messages, electronic submission of documents and

electronic signatures in the Food and Drug Administration pursuant to

Republic Act 8792 or the “Electronic Commerce Act of 2000”.

III. SCOPE

This Order shall cover products under household/urban hazardous substances as

defined in the Republic Act 9711 and its Implementing Rules and Regulations and

shall apply to establishments in the country. It shall also cover entities engaged in the

testing, promotion, advertising, or sponsorship of household/urban hazardous

substances, including facilities and installations needed for its activities.

However, it shall NOT apply to or cover the following establishments or persons

as prior to commencement of their business activity:

1. Manufacturer, Trader, or Distributor of (Importer/Exporter/Wholesaler) of the

following:

1.1 Household Pesticides – in so far as licensing and registration since there

is a separate A.O. for this product;

1.2 Toys and Childcare Articles (TCCAs) – in so far as registration and

labelling since there is a separate A.O. for this product;

1.3 Disinfectants that are intended for veterinary and aquaculture use

including their environment or surroundings, facilities and equipment.

Likewise, raw materials intended for use as a component in the

manufacture of the said as stated in Joint DOH and DA Administrative

Order No. 2013-0026; and,

1.4 Disinfectants and Adhesives, all types, of medical device as stated in

FDA Memorandum Circular No. 2014-005.

2. Toy balloons when so inflated with any toxic, explosive or flammable gas as

stated in the Implementing Rules and Regulations (IRR) of Fire Code of the

Philippines of 2008;

3. Retailers or retail outlets of household/urban hazardous substances except in

the case provided in Part VI. General Guidelines No. 4 below;

4. Organizers of national and international trade fairs and exhibits for H/UHS;

and;

5. Organizations or persons engaged in donations, medical missions and other

humanitarian activities.

IV. DEFINITION OF TERMS

The terms used and defined in this Administrative Order shall have the meaning

as defined in Republic Act No. 3720, as amended by Republic Act No. 9711 and its

IRR and other related laws and regulation. In addition, the following terminologies

shall be defined as:

1. Electronic Licensing/ Registration refers to the process of licensing and

registration done online. (n)

2. Household/ Urban Hazardous Substance refers to:

(a) Any substance or mixture of substances intended for individual or limited

purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is

flammable or combustible, or generates pressure through decomposition,

heat or other means, if such substance or mixture of substances may cause

substantial injury or substantial illness during or as a proximate result of

any customary or reasonably foreseeable ingestion by children, but shall

not include agricultural fertilizers, agricultural pesticides, and agricultural

insecticides and other economic poisons, radioactive substances, or

substances intended for use as fuels, coolants, refrigerants and the like;

(b) Any substance which FDA finds to be under the categories enumerated in

paragraph (1) of this section;

(c) Any toy or other articles intended for use by children which the FDA may

determine to pose an electrical, chemical, physical, or thermal hazard. For

this purpose “toys and other articles intended for use of children” shall

refer to those toys and articles specified to be for children less than

fourteen (14) years of age; and

(d) The term Household / Urban Hazardous Substance shall not apply to

food, drugs, cosmetics, devices, or to substances intended for use as fuel

when stored in containers and used in the heating, cooking or

refrigeration system of a house, but such term shall apply to any article

which is not in itself an agricultural pesticide but which is a hazardous

substance, as construed in paragraph (1) of this section, by reason of

bearing or containing such harmful substances described therein.

3. Licensing refers to the process of approval of an application to operate or

establish an establishment prior to engaging in the manufacture, importation,

exportation, sale, offer for sale, distribution, transfer, and where applicable

the use, testing, promotion, advertisement, and/ or sponsorship of health

products.

4. Marketing Authorization (MA) refers to the approval granted by the

National Regulatory Authority (NRA) to market a specific product in a

particular country. The NRA in the Philippines is FDA. The MA issued by

the FDA is Certificate of Product Registration (CPR).

5. Marketing Authorization Holder (MAH) refers to the company named on

the Marketing Authorization for a specific product in a particular country.

The owner of the CPR issued by the FDA is the MAH.

6. Registration refers to process of approval of an application to register health

products prior to engaging in the manufacture, importation

7. Risk refers to the likelihood that a person may be harmed or suffers adverse

health effects if exposed to a hazard.

8. Variation refers to amendments/ change of circumstances.

V. RISK CLASSIFICATION OF HOUSEHOLD/URBAN HAZARDOUS

SUBSTANCES OR MIXTURES OF SUBSTANCES SHALL INCLUDE,

BUT NOT LIMITED TO, THE FOLLOWING:

1. High Risk substances or mixtures of substances includes, but are not

limited to, the following:

Paints, Paint Primers, Enamel Paints, Lacquers, Varnishes, Solvents,

Thinners (Removers/Strippers)

Dyes and Paints - Textile and Leather (industrial/backyard)

Adhesives/Adhesive Removers

Sealants

Protectants (shoe/bag/boot/fabric/leather protectant)

Polishes (furniture/floor/car/tire/metal/shoe)

Waxes (floor/car)

Degreasers/Decloggers

Bleaches

Corrosive Cleaners/Descaler Agents (Drain Cleaners/Decloggers, other

Metal and Jewelry cleaners/descalers)

Batteries (Button/Cylindrical)

Toys and Childcare Articles (TCCAs) – Toys (Soft-Filled, Electrical,

Educational, Ride-On, Pull Toys, Aquatic Toys, For Indoor and Outdoor

Use, Toys with Magnets, Sound-Producing, Projectile, Toy Masks and

Toy Box, a child can enter)

Childcare Articles (Feeding Bottles and Sippy Cups)

Multi-purpose Cleaners/Sanitizers/Detergents in powder, liquid and paste

forms (carpet/rug/glass/bathroom/laundry/Kitchen aids/tools/utensils and

surfaces/Household/equipment/machine used in food processing or with

food contact – e.g. soft drinks bottle)

Washes/Cleaners/Rinses – e.g. egg, vegetable or fruit

Dyes (Tattoo), Ink and Toner

Garden Fertilizers and Household Pesticides

Corrosion or Rust Inhibitors/Lubricants – for

Equipment/Machineries/Automotive

Solder flux

2. Low Risk substances or mixtures of substances includes, but are not

limited to, the following:

School/ Office Supplies and Hobby Items – Glues (glue gun stick and

liquid glues) and paste; Educational set such as ballpens, highlighting

pens, colored pens, crayons, pencils, chalks, watercolors, oil paints, oil

pastels, erasers (liquid and rubber erasers, correction tapes paper);

Scented Stationeries; False eyelashes (synthetic); Hair extensions

(synthetic); Artificial nails;

Deodorizers and Room Fresheners – Scented Candles, Humidifier/

Dehumidifying Agent such as essential oils, fragrance and Car Fresheners

Laundry Aids – Fabric conditioners/ softeners, Wrinkle removers, Ironing

aids, Laundry Starch

Toys and Childcare Articles (TCCAs) – Toys (Soft-Filled, Electrical,

Educational, Ride-On, Pull Toys, Aquatic Toys, For Indoor and Outdoor

Use, Toys with Magnets, Sound-Producing, Projectile, Toy Masks and

Toy Box- A child can enter)

VI. GENERAL GUIDELINES

1. All covered H/UHS establishments shall secure a License to Operate (LTO),

Certificate of Product Registration (CPR) or an appropriate authorization

from FDA before engaging in the manufacture, importation, exportation, sale,

offer for sale, distribution, transfer, use, testing, promotion, advertising, or

sponsorship of household/urban hazardous substances pursuant to this

Administrative Order.

2. All H/UHS establishments shall first apply and secure for LTO. Once the

FDA-granted LTO is acquired, A CPR initial application should be filed.

3. The responsibility of ensuring the safety, efficacy, and quality of any

household/urban hazardous substances sold/distributed in its original

packaging (container) of which the seal has not been broken or tampered with

shall rest upon the household/urban hazardous substances establishments

involved in the supply chain of sale, handling, transport, distribution, trading

and storage, among others. The foregoing responsibility also applies to

organizations or persons engaged in donations, medical missions and other

humanitarian activities.

4. All covered establishments must continuously comply with the existing

requirements, regulations and standards for H/UHS, otherwise the

establishment may be ordered closed or their licenses or the CPR for the

product suspended or revoked motu propio or upon petition by any person.

5. A violation with any of the terms and conditions set in the LTO, CPR or in

any market authorization (when applicable) issued by FDA, or in any of their

undertaking as a requirement for their application for authorization shall

likewise result in the suspension, revocation or cancellation of the

authorization.

6. All covered establishments engaged in the importation of H/UHS, which

imported product have been banned or withdrawn for health and safety

reasons in the country of manufacture or country of origin shall not be

imported or offered for import, sale or use in the Philippines and shall

likewise be refused admission.

7. All covered establishments shall immediately recall, or withdraw from public

sale or distribution any H/UHS that is declared to be imminently injurious,

unsafe or dangerous, as determined by the FDA.

8. All entities that join government or non-government bidding activity shall

have LTO, CPR and/or any approved authorization duly issued by the FDA.

9. All establishments shall abide with the guidelines of the FDA on electronic

submissions and processes of the LTO, CPR or any market authorization into

electronic format pursuant to RA 8792 or the “Electronic Commerce Act of

2000”.

10. The fees and charges for all H/UHS authorization applications shall be based

on the current prescribed fees and charges as implemented by the FDA.

11. All imported H/UHS including raw materials for its production forfeited and

refused admission into the country by reason of safety and quality or

unregistered (finished product) with FDA shall be subject to destruction or

return to country of origin or manufacture.

12. All raw materials that are not covered by any other regulatory agencies such

as EMB-DENR, DDB, FPA and PNP (issuance) shall be under the

jurisdiction of the FDA.

VII. SPECIFIC GUIDELINES

A. E-LTO REQUIREMENTS

The following are the requirements for application of a License to Operate

(LTO):

1. Initial Application

1.1 Accomplished Application Form and Declaration and Undertaking

1.2 Proof of Business Name Registration

1.3 Site Master File (for manufacturers only)

1.4 Payment

2. Renewal Application

2.1 Accomplished Application Form with Declaration and Undertaking

2.2 Payment Guidance for the above requirements is attached as Annex

"A".

3. Variation Applications

Variations shall require prior FDA approval. Variations may either be

major or minor.

3.1 Major variation covers changes in the operations of the establishment

that may affect significantly and or directly the aspects of safety and

quality and when applicable, efficacy of products. Major variation

shall only be approved upon proper notification, compliance to

requirements and inspection.

3.2 Minor variation covers changes in administrative matters and/or

changes in the operations of the establishment but with minimal impact

on the safety, quality and, when applicable, the efficacy of products.

3.3 The list of variations, the conditions, and the documentary

requirements is attached as Annex "_".

4. Authorized Representative to be given the user account:

LTO Type Qualified Person Requirement

1. Household/Urban

Hazardous

Substances (HUHS)

Owner/ Proprietor or any

qualified professional

QPIRA-

certified

2. Household Pesticide

(HP)

Owner/ Proprietor or any

permanent/technical staff (any

allied health profession

including but not limited to

Entomologist, Chemist,

QPIRA-

certified or

PRC License

(if

applicable)

Chemical Engineer, etc.)

3. Toys and Child Care

Articles (TCCA)

Owner/ Proprietor or any

qualified professional

QPIRA-

certified

B. E- LICENSING PROCEDURE

1. Filing

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.

2. Evaluation

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. Should

there be a need for clarification on the application, a notification, either

written or through e-mail, shall be sent to the applicant.

3. Inspection

Pre-opening inspection shall be mandatory for manufacturers. All

covered establishments may be inspected at any time by FDA as part of

its post-marketing surveillance activities.

3.1 The FDA Director-General may issue orders to categorize certain

variations which are not included in the enumeration as either major

or minor variation.

C. LTO VALIDITY AND FEES

The validity of LTOs and the applicable fees and other charges shall be

covered by separate issuances.

D. CANCELLATION OF LTO

1. Automatic. Existing establishments that fail to file an application for

renewal after one-hundred twenty (120) days from the date of expiration

shall be automatically cancelled and deleted from the list of licensed

establishments without prejudice to their re-application.

2. Voluntary. The owner or authorized person of a licensed establishment

may apply for voluntary cancellation of its existing license by filing a

formal notification with the FDA.

3. Cancellation as a Penalty. The FDA may also impose the penalty of

cancellation of license for violation of FDA-implemented laws covering

H/UHS.

4. When the license is cancelled either automatically or voluntarily, the

FDA shall retain jurisdiction over violations committed by the

establishments while it was in operation.

E. ACCESSIBILITY

1. The relevant forms, requirements for application, and the submission

process shall be made accessible at the FDA Website.

2. All approved LTO through e-LTO applications shall be sent through

courier directly to the establishment’s owner, president, CEO, general

manager or equivalent responsible officer as indicated in the application

form.

F. E-REGISTRATION REQUIREMENTS

1. All HUHS including household pesticides and TCCAs shall follow e-

registration process.

2. All H/UHS including household pesticides having the same formulation

but packed in different packaging presentation shall be treated new

product and shall have a different CPR.

3. All applicants must be a holder of a valid LTO.

4. Using the E-Registration system, the initial registration shall require the

encoding of all the product information for every product application and

submission of all labels and supporting documents. The issuance of

Certificate of Product Registration shall be based on the completeness of

the submitted documents.

5. The Company E-registration Account Holder may apply for their

respective products registration (Initial, Renewal, Amendment, Re-

Issuance or Cancellation) through the E-portal filed through the E-

registration system,. The account holder shall be the authorized

representative of the Market authorization holder (MAH).

6. Succeeding variations of HUHS products approved through the online

registration system shall cover the following changes:

6.1 Major Variations:

Change in label content/ information such as product claims

Change/Extension in Shelf-Life (applicable only to household

pesticides)

Change in Product Claims

Change in packaging presentation (To file for initial application)

Any additional packaging presentation (To file for initial application)

Transfer of manufacturer’s location/ address (To file for initial

application)

Transfer of Ownership of a Registered Product (To file for initial

application)

Change and/or Addition of Supplier- *For distributors only (To file for

initial application)

6.2 Minor Variations:

Additional Packaging Size

Change in label design without change in product information/

contents

Change in Business/Company Name

Change in Business/Company Address- *For distributors only

Other cases as declared in succeeding FDA issuances

7. Applications for Renewal without changes from the previously approved

product information and label shall be qualified for automatic renewal

upon application. Approved renewal applications shall be valid for a

minimum of two (2) years and a maximum of five (5) years.

8. Should a product fail to meet the requirements for product registration,

applicable product standards and labeling regulations, a Letter of

Disapproval shall be electronically issued to the inbox of the respective

user account of the applicant. The applicant may file for re-application.

9. Application Process

9.1 Issuance of a CCRR E-Registration User Account

9.1.1 The CCRR E-Registration User Account and Password is

company-specific. An officer/representative handling multiple

companies shall secure a separate user account and password for

each respective company.

9.1.2 The applicant shall be assigned an FDA account in order to

apply through e-registration. The applicant shall secure a

notarized authorization letter from the company (with a valid

License-to-Operate Number) being represented (Annex B) or the

company account holder. He/She shall send a request for a User

Account to info@fda.gov.ph following the format specified

below with the scanned notarized authorization letter.

SUBJECT: CCRR: E-Registration

BODY: Email Address:

Last Name:

First Name:

Middle Name:

Company Name:

9.1.3 The issued CCRR E-Registration User Account shall be sent to

the e-mail provided in the request.

9.1.4 When there is a change of the representative of the applicant

company, the applicant shall request for a change in credentials

of the CCRR E-Registration User Account by sending an e-

mail to info@fda.gov.ph with “CCRR: E-registration” as the

subject and attaching a scanned copy of the Affidavit of

Undertaking (Annex __).

9.1.5 Accomplishing Online Registration Applications

9.1.5.1 All information filled out by the applicant during the

process shall be reflected in the final output (either

CPR or Letter of Disapproval). Thus, it is imperative

for the client to be careful and diligent in filling out all

required information.

9.1.5.2 Fill out all necessary information in ALL CAPS,

except for Trademark, Corporate De Facto (e.g.

GmbH) and e-mail address.

A MINIMUM of three (3) contact information in the form

of E-Mail, Telephone and Mobile Number must be declared.

9.1.5.2 Declare ALL ingredients in DESCENDING order of proportion. For

multi-component ingredients, indicate the phrase “as follows” in

parenthesis after the ingredient and declare each specific component also

in parenthesis.

9.1.5.3 In declaring the product specifications for physical, chemical, and

microbiological parameters, ensure the completeness and accuracy of the

details since these shall be verified later during Post-Market Surveillance

(PMS).

9.1.5.4 In attaching Product Labels or other supporting documents (e.g.

Certificates of Analyses, LD50, etc.) make sure that ALL information are

reflected CLEARLY and ACCURATELY. Limit the total size of

attachments to 20 MB with a limit of 2 MB per file using the format

“.png” or “.pdf”.

9.1.5.5 Pictures of actual product in all angles and scanned unattached label

clearly reflecting complete information and shall be named following the

format “Label (Case Number)”, e.g. “Label_36252.pdf” or “

Label_36252.png”.

10. Initial Application

10.1 Access the online portal through https://www.fda.gov.ph.

Provide the company-specific Username and Password, and

then click the “CCRR Electronic Registration – HUHS Product

Registration (Initial Application Form)”.

10.2 Read carefully the “DECLARATION” before proceeding with

the application process. The “DECLARATION” conveys a

binding agreement between the applicant and the FDA to

provide complete and accurate information, assuming full

responsibility for the safety of the product being registered,

with an undertaking to comply with all applicable rules and

regulations. Clicking the “Yes, I agree” button shall continue

the registration process. If the user fails to do so, access to

proceed to E-Reg shall be denied.

10.3 After providing the required information, a system-generated

Order of Payment shall be received. Make sure that all

information are complete and correct before making any

payment.

10.4 Pay the corresponding assessed fee through the FDA Main

Office Alabang Cashier or BancNet online payment gateway

following the procedure per FDA Advisory 2015-021 or any

applicable payment system prescribed by the FDA.

10.5. See “Annex A for Checklist of Requirements”.

11. Variation/Renewal Application

11.1. To apply for amendment or renewal, access the online portal through

https://www.fda.gov.ph. Provide the company-specific Username and

Password, and double click on the specific product in the Inbox folder.

11.2. Select the type of application from the drop-down menu after the

“Declaration”.

11.3. Provide the required information completely and accurately.

VIII. LABELLING

The following minimum mandatory information shall appear in the label

of a household/urban hazardous substance except Household Urban

Pesticides (HUP) and Toys and Childcare Articles (TCCAs) which shall

follow existing rules and regulations as prescribed under RA 10620 and its

IRR (See Annex B for the Checklist of Requirements):

a. Product Name

b. Full ingredient list (in descending order by percentage)

c. Intended use

d. Net Content

e. Storage Condition and Disposal

f. Directions for Use

g. Name and address of the market authorization holder

h. Caution/Warning (Hazard Statement)

i. Instructions for First Aid Treatments

j. Contact Information of Local Poison Control Units (UP-PGH)

k. Batch Number/Lot Number

l. Expiration Date

IX. ADVERTISEMENT, PROMOTION OR SPONSORSHIP

1. All H/UHS shall first be registered with the FDA before these are

promoted, sponsorships or other marketing activities.

2. Sales Promotion Permits will be secured following the applicable rules

and regulations implemented by FDA such as FDA Memorandum

Circular 2013-028 “GENERAL GUIDELINES ON THE PROMO

PERMIT APPLICATIONS AND FOR OTHER PURPOSES” AND ITS

AMENDMENTS.

3. As a general rule on duration - Sales promotion campaign shall have a

duration of not more than a year, extendible to a maximum of 6 months

upon approval by the department.

3.1 Requirements:

a. INITIAL APPLICATION:

1. PAIR Integrated Application Form

2. Duly Accomplished Information Sheet (can be

downloaded in the FDA website)

3. Copy of Valid Product Notification or Certificate of

Product Registration

Tabulated copy with the following format

a. Product Name – Notification/CPR – Validity)

b. Layout of Promo Materials

c. Proof of Payment (will be based on the amount of

prizes/premium)

b. AMENDMENT APPLICATION:

1. PAIR Integrated Application Form (can be downloaded in the

FDA website)

2. Letter of Intent (specifying the type of Amendment)

3. Proof of Payment (Php 310.00 fixed price)

4. Copy of previously Issued Promo Permit

Basic Permit Conditions

1. The approved sales promotion materials/announcements shall contain the

phrase “DOH-FDA -CCRR Permit No. ________ s. ____”.

2. No statement shall be made in the sales promotion, advertisement and

collateral materials that would suggest directly or indirectly that the

product has therapeutic values.

3. An authorized DOH-FDA representative should be invited and/or notified

to witness and attest the specific promotion activity at least one (1) week

before the activity.

4. All offices of the Center for Health Development (DOH-CHDs) should be

furnished with a copy of this permit together with the approved mechanics

and materials (if submitted).

5. Notwithstanding the approved duration, the authorization for the subject

promotion shall be valid only until the validity of the Certificate of Product

Registration/Notification of the participating products, unless their

respective registration/notification is timely renewed/re-applied.

6. A report of completion should be submitted to this Office immediately

after the subject promotion shall have been concluded.

7. The complete list of participating outlets should be submitted within ten

(10) days from receipt of this permit or immediately after finalization of

the same.

8. Health Products listed in the application with expired

Registration/Notification should not be included in this sales promotion

activity.

X. REPEALING CLAUSE

A.O. 303 s. 1976 or the “Registration of Hazardous Substances and

Manufacturer of Hazardous Substances”, A.O. 311 s. 1977 or the “Labelling

Requirements of Hazardous Substances”, A.O. 312 s. 1977 or the “Household

Hazardous Substances”, FDA Circular 2013-009 or the “Revised Guidelines

in Licensing of Household/ Urban Hazardous Substance Establishments and

its amendment”, FDA Memorandum Circular 2013-045 or the Guidelines on

Notification of Selected Household/Urban Hazardous Substances (HUHS)

Products and A.O. 2015-0038 or the “Removing the Requirements of

Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers,

Retailers, or Re-Packers of those Engaged in Certain Household/Urban

Hazardous Substances, and from the Requirement of Prior Registration

and/or Notification of said Products” and other issuances of Department of

Health (DOH) and FDA not consistent with the provisions of this Order are

hereby repealed or modified accordingly.

XI. TRANSITORY PERIOD

All HUHS except HP and TCCAs shall file initial applications for

licensing and registration within six (6) months upon effectivity of this

issuance.

Upon the approval of CPR the company is given twelve (12)

months to exhaust the remaining unregistered products and submit inventory.

Unused old labels shall no longer be used/recycled and must be inventoried

and disposed properly.

All valid LTO shall be renewed three (3) months prior to

expiration following the e-LTO scheme

All valid marketing authorizations issued prior the effectivity of

this AO shall be deemed valid until its expiry. After which, an initial

application for the product shall be filed following the guidelines as

prescribed in this Order.

XII. SEPARABILITY CLAUSE

If any provision is declared unauthorized or rendered invalid by any

court of law or competent authority, those provisions not affected thereby

shall remain valid and effective.

XIII. EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication in a

newspaper of general circulation and after filing with the Office of National

Administrative Register (ONAR), University of the Philippines Law Center,

Quezon City.

PAULYN JEAN B. ROSELL-UBIAL, MD, MPH, CESO II Secretary of Health

Office FDA OHR HPDPB/OHS OSEC

Initial

NELA CHARADE G.

PUNO, RPh.

Director General

MARIO C. VILLAVERDE, MD,

MPH, MPM, CESO II

Undersecretary

LILIBETH C. DAVID, MD,

MM

Undersecretary

CORAZON LUCIA

TEOXON, MD

Head Executive Assistant

Date

Keywords HUHS, Repeal, CPR, LTO

Related Issuances, Laws, Directives PD 881, RA 9711, AO 303, AO 311, AO 312, AO 2015-0038, AO 50 S. 2001, RA

8792, FMC 2013-004, FDA 2013-009