1st draft administrative order subject: revised rules and ... ao on huhs 032017 for...
TRANSCRIPT
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 [email protected] 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 [email protected] 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