FDA Memorandum Circular No.2013 045
FDA Memorandum Circular No.2013 045
FDA Memorandum Circular No.2013 045
Department of Health
FOOD AND DRUG ADMINISTRATION
14 November 2013
N2.013- 0495
LL RATIONALE/BACKGROUND
The Food and Drug Administration (FDA) recognizes the need to keep its standards,
rules and regulations at par with the rest of the regulatory agencies across the
globe. Complex
regulations and requirements may potentially pose as barriers to trade and
innovative
technology. To support the country’s economic progress, a more simplified
regulatory
scheme is needed. Industries should be allowed to meet the fast changing needs and
demands
of consumers for safer products. Notification encourages innovations and
technological
advancement as well as national competitiveness of the manufacturing and export
industries,
paving the way for accelerated economic growth.
In this light, the FDA outlines the guidelines for the application of selected HUHS
through the Notification Scheme. This simplified approach places the responsibility
primarily
in ensuring the safety and quality of the products on the companies. However, the
FDA shall
strengthen post-marketing surveillance (PMS) to ensure continuous compliance of the
companies to FDA safety and quality standards.
Section 10 of Republic Act no. 9711 considers a prohibited act “the manufacture,
importation, exportation, sale, offering for sale, distribution, transfer, non-
consumer use,
promotion, advertisement, or sponsorship of any health product which, although
requiring
registration, is not registered with the FDA pursuant to this Act.
The following products covered are: a) Paints, lacquers, varnish; b) Solvent paint,
lacquer thinner, mineral spirits; c) Adhesives (contact cement); d)Polishes and
Waxes (metal
polish, wood polish, shoe polish); e¢) Bleaches; f) Cleaners; g) Disinfectant
sprays; h)
Detergents (bar, liquid and powder); i) Dishwashing (liquid and paste); j)
Glues/Paste; k)
Fabric (dyes, softeners, conditioners); I) Educational set and miscellaneous
chemistry set
(paste, crayons, pencils, water colors, glue stick/glues. correction fluid/rubber
eraser,
crayons, oil pastels, art paints, chalk, moulding clays); m) Stationeries/ Art
paper (colored
and/or scented); n) Air Fresheners (deodorizer, fabric freshener, aromatherapy
product,
scented candles, gels, oil, spray), and the like. Product notification is
applicable per
formulation per packaging presentation.
III.
Department of Health
FOOD AND DRUG ADMINISTRATION
GUIDELINES
1.
Applicability
One (1) notification application per product formulation per packaging
presentation is required.
B. Source of the product and all other pertinent information as to the name of
the importer/distributor/trader and manufacturer of the product,
Declaration stating among others: the full responsibility over the product,
the availability of product information file, reports of adverse events and
full cooperation on post-marketing activities.
mo 0
For Products with Existing Registration
LTO Requirement
A valid LTO shall be required for notification application.
Republic of the Philippines FDA
Department of Health
FOOD AND DRUG ADMINISTRATION
V. TRANSITORY PERIOD
1. Companies may opt to request for the cancellation of their previous application
and existing valid CPRs, and avail of the new Notification scheme. (Note:
Previous payments made are non-refundable and non-transferable)
2. Existing CPR shall remain valid and recognized until expiration or replacement
by
Notification.
3. All applications received prior to the implementation of this Notification
scheme
VI. REQUIREMENTS
ii. Completely fill out the fields in the template with the necessary
information and print as is on A4 size paper. A separate sheet may be
attached for the formulation of products exceeding the designated
space provided (Product Ingredient List table under item number 5).
accommodated.
5. A claim stub or document tacking log for each HUHS notification application
will be issued bearing the notification number.
7. The FDA reserves the right to issue a letter/notice to the company in case of
The HUHS notification application shall be processed and completed within twenty-
two (22) working days provided the application complies with the requirements.
The HUHS notification shall be valid for a period of one (1) year.
XIII. SEPARABILITY CLAUSE
XIV. EFFECTIVITY
) ye —
KEXNEXH ¥ HARTIGAN-GO, MD
Acting Director General
Republic of the Philippines
Department of Health Pome mut firm LA
FOOD AND DRUG ADMINISTRATION
PE eg
ANNEX 1
PARTICULARS OF PRODUCT
Glues/Paste
Bleaches
Cleaners
Disinfectant sprays
Sachet
Pouch
Doy pack
Plastic bottle
Plastic gallon —
Republic of the Philippines
=r
Department of Health )
FOOD AND DRUG ADMINISTRATION FDA...
Full ingredient name (use appropriate acceptable common Function Amount, Percentage
(%)
name or approved nomenclature in standard references,
include CASH if available)
6. Name of manufacturer:
Tel: Fax:
PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE PRODUCT IN THE MARKET
7. Name of company:
Address of company:
Tel: Fax:
8. Name of Person;
Fe
Department of Health );
FOOD AND DRUG ADMINISTRATION FDA = 7 if /
PARTICULARS OF IMPORTER?
9. Name of Importer
Address of Importer:
Tel: Fax:
DECLARATION
o | undertake to respond to and cooperate fully with the regulatory authority with
regard to any subsequent post-marketing
activity initiated by the authority.
o l undertake fo ensure that the product's technical and safety information is made
readily available to the regulatory
authority concerned (“the Authority”) and to keep records of the distribution of
the products for product recall purposes.
0 | declare that the particulars given in this notification are true, all data, and
information of relevance in relation to the
riotification have been supplied and that the documents enclosed are authentic or
true copies.
The company shall present upon audit the hereunder information as part of the
product information file of each notified product. The company responsible for
placing the
product in the market shall keep a Product Information File (PIF) as part of the
undertaking
I. Administrative Documents
1. Copy of the Acknowledged Product Notification
2. Valid License to Operate (LTO) with the following supporting documents:
i. For Manufacturers
1. List of HUHS Distributor/s
2. List of product lines
it. For Distributor ( Importer/ Exporter/Wholesaler)
Labeling Materials
rl BC ol
IV. Representative Sample (for each packaging size and packaging presentation, with
the
commercial packaging/label consistent with the declared information in the product
notification, and is in accordance to Department of Health Administrative Order no.
311 series of 1977, or the current guidelines set by the department)