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THE
MINISTRY OF HEALTH
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
06/2011/TT-BYT
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Hanoi,
January 25, 2011
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CIRCULAR
PROVIDING
FOR COSMETIC MANAGEMENT
Pursuant to the Government’s Decree
No. 188/2007/ND-CP dated December 27, 2007 on functions, tasks,
powers, and organizational structure of the Ministry of Health;
Pursuant to the Government’s Decree No. 132/2008/ND-CP dated December
31, 2008 elaborating a number of Articles of the Law on Products and Goods
Quality;
Pursuant to the Government’s Decree No. 24/2003/ND-CP dated March 13,
2003 elaborating to implementation of Ordinance on Advertisement;
Pursuant to the Government’s Decree No. 89/2006/ND-CP dated August 30,
2006 on goods labelling;
Pursuant to the Government’s Decree No. 12/2006/ND-CP dated January
23, 2006 elaborating to the Commercial Law on international trade in goods and
commercial agency, trading, processing and transit of goods with foreign
countries;
Pursuant to the Prime Minister’s Decision No. 10/2010/QD-TTg dated
February 10, 2010 prescribing the Certificate of Free Sale for exported and
imported products and goods;
In the furtherance of the Agreement on ASEAN Harmonized Cosmetic Regulatory
Scheme signed on September 02, 2003 (hereinafter referred to as “ASEAN
Agreement on Cosmetics”), the Ministry of Health provides for cosmetic
management as follows:
Chapter I
GENERAL
PROVISIONS
Article 1. Scope and regulated entities
1. This Circular
provides for management of domestically manufactured cosmetic products and
imported cosmetics for circulation in Vietnamese territory, including:
notification of cosmetic products; product information file; product safety
requirements; cosmetic labeling; cosmetic advertising; cosmetic import and
export; cosmetic sampling for quality inspection; examination, inspection and
handling of violations; responsibilities of manufacturers, traders and
importers of cosmetics and consumers' rights.
2. This Circular
applies to state management agencies for cosmetics, organizations and
individuals conducting activities related to notification of cosmetics,
communication, advertisement, import, export and trading of cosmetics in
Vietnam.
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For the
purposes of this Circular, the terms below shall be construed as follows:
1. “cosmetic product” means any substance or a
preparation intended to be placed in contact with the various external parts of
the human body (epidermis, hair system, nails, lips and external genital
organs) or with the teeth and the mucous membranes of the oral cavity with
a view exclusively or mainly to cleaning them, changing their appearance and/or
correcting body odors and/or protecting them or keeping them in good condition.
2. “cosmetic
name” means the name given to a cosmetic product, which may be
an invented name, together with a trade mark or the name of the manufacturer.
The characters that make up the cosmetic name must be characters with the
origin of the Latin alphabet.
3. “organization
or individual responsible for placing a cosmetic product in the market” means
an organization or individual whose name is written on the cosmetic product
notification dossier and that is responsible for that cosmetic product on the
market.
4. “cosmetic
product notification number” means a number issued by a competent
state management agency upon receiving a cosmetic product notification dossier.
Notification number is meant to certify that the organization or individual
responsible for placing a cosmetic product in the market has declared its
circulation on the market to competent state management agencies but is not
meant to certify that cosmetic product’s safety and efficacy and compliance
with all requirements under the ASEAN Agreement on Cosmetics and its Annexes.
5. “cosmetic
product owner” means an organization or individual possessing
formula, manufacturing process and product quality standard.
6. “product
stability” means the ability of a product to remain its
original properties and especially maintain its satisfaction of safety
requirements when preserved under suitable conditions.
7. “quantity” means
the quantity of cosmetic products expressed in net weight or volume in either
metric or both metric and imperial system.
8. “cosmetic
label” means written copies, printed copies, drawn copies and
photocopies of letters, drawings and images which are directly pasted, printed,
attached, forged, embossed or engraved on products, consumer packaging thereof
or other materials attached on products or consumer packaging thereof.
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10. “original
label” means the label displayed on consumer packaging of
cosmetics for the first time.
11. “auxiliary
label” means a label representing compulsory information that
must be translated from a foreign language into Vietnamese for the original
label and adding mandatory information in Vietnamese to the original label (if
any) as specified under this Circular.
12. “consumer
packaging of cosmetics” means that contains and is circulated with
cosmetics. Consumer packaging of cosmetics consists of: immediate packaging and
outer packaging.
a)
Immediate packaging means the packaging that contains the product, comes into
direct contact with the product, creates shapes or is wrapped along product
contour.
b) Outer
packaging means the packaging that is used to cover one or more product units
placed in the immediate packaging.
13. “cosmetic
circulation” means the display, transport and storage of the
product during its trading, except for transport of products of organizations
and individuals that import products from border checkpoints to storage.
14. “cosmetic
manufacturing batch number” means a code in number or letter or
a combination of both intended for recognizing a product batch and allowing
traceability of a product batch including all stages of
manufacturing process, quality inspection and distribution.
15. “date
of cosmetic manufacture” means the date on which manufacturing,
processing, packaging or other activities are completed to finish the last
stage of a product batch.
16. “expiry
date of cosmetic” means a date designated for a cosmetic batch
after which the cosmetic batch must no longer be circulated and used.
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18. “cosmetic
origin” means a country or territory where cosmetics are
produced in their entirety or where the final basic preparation stage is
conducted in case multiple countries or territories participate in
manufacturing the cosmetics.
19. “Certificate
of Free Sale” (hereinafter referred to as “CFS”) means a
certificate issued by a competent agency of the exporting country to a cosmetic
exporter written on the CFS to certify that the cosmetics are manufactured and
licensed for free sale in the exporting country.
20. “instructions
for use” means necessary information that instructs users to
use cosmetics safely and reasonably. Instructions for use may be printed on the
immediate packaging or introduced in the form of a documents attached to the
consumer packaging of cosmetics in which the instructions for use and other
details are written as per the law.
21. “cosmetic
advertising” means the introduction and marketing of cosmetics
to promote manufacturing process, sale and use of cosmetics.
22. “cosmetic
launch seminar or event” means a conference which is intended
for instruction or discussion about specialized topics with consumers regarding
in-depth issues relating to cosmetics.
23. “advertiser”
means any organization or individual wishing to advertise cosmetics that
they produce and/or distribute.
24. “advertisement
publisher” means any organization or individual that brings
cosmetic advertisements to consumers, including press agencies, communication
agencies, television agencies, publishing houses, computer network managers,
organizers of cultural programs, sports programs, fairs, exhibits and
organizations, individuals employing other forms of advertisements.
25. “ASEAN
Cosmetic Committee” means an agency representing ASEAN member
countries to monitor, decide and deal with disputes involving the
implementation of the ASEAN Agreement on Cosmetics.
Chapter II
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Article 3. Regulations on notification of cosmetic products
1.
Organizations and individuals responsible for placing cosmetic products on the
market are only allowed to circulate the cosmetics after receiving the cosmetic
product notification number from the competent state
management agency and must be entirely responsible for product safety,
efficacy and quality. The competent state agency shall conduct post-sale
inspection once products are circulated on the market.
2. Charges
for notifying cosmetic products shall conform to applicable laws.
3.
Organizations and individuals responsible for placing products in the market
must be licensed to trade in cosmetics in Vietnam.
4. Cosmetic
product claims (intended uses of the products) shall be made in accordance with
ASEAN Cosmetic Claim Guideline (Annex No. 03-MP).
Article 4. Cosmetic product notification dossiers
A cosmetic
product notification dossier consists of the following documents:
1. 02
physical copies of the notification of cosmetic product enclosed with a soft
copy thereof;
2. A copy of the business registration certificate of the
organization or individual responsible for placing the product in the market
(bearing signature and seal of the enterprise). In case the
cosmetic is domestically manufactured but the organization or individual
responsible for placing the product in the market is not the manufacturer, a
legitimate certified true copy of the manufacturer’s business registration
certificate is required;
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4. CFS: Applicable only to the notification of imported cosmetic
products and subject to the following requirements:
a) The CFS
issued by the home country must be an original or a certified true copy which
is legitimate and remains unexpired. Where the CFS does not specify its validity period, it must be issued within 24
months from the date of issuance.
b) The CFS
must be consularly legalized in accordance with law, except where consular
legalization is exempted under treaties to which Vietnam is a signatory.
Article 5. Instructions for preparation of notification of
cosmetic product
1.
Notification of cosmetic product:
a) A
notification of cosmetic product shall be prepared in accordance with the Annex
No. 01-MP to this Circular. The notification of cosmetic product must bear the
signature of the legal representative or the signature and the joint-page-seal of the organization or individual
responsible for placing the product in the market. The notification of cosmetic
product shall be filled according to the Annex No. 02-MP to this Circular.
b) Each
cosmetic product shall have its own notification.
A separate
notification shall be made for each finished cosmetic product of a
manufacturer. Where more than one manufacturer engages in the manufacture of a
finished cosmetic product, a notification shall be made for such product and
shall clearly state the name and full address of each manufacturer.
Products
of the same owner may be covered by a single notification in any of the cases
below:
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- Products
with the same name and in the same product line have similar formulas but vary
in color or scent. For hair dyes and perfumes, their color or scent must be
covered by a separate notification.
- Other
types may be decided by the Drug Administration of Vietnam under the Ministry
of Health according to the ASEAN Cosmetic Committee’s decision.
Methods of
specifying ingredients present in the formulation of a cosmetic product:
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Ingredients president in a product formulation must be specified in full in
descending order of content. Perfume and aromatic compositions and their raw
materials may be referred to by the word “hương liệu” (“perfume”,
"fragrance”, “flavor” or “aroma”). Ingredients in concentrations of less
than 1% may be listed in any order after those of concentration of more than 1%
content. Coloring agents may be listed in any order after the other
ingredients, in accordance with the color index number (CI) or denomination
adopted in Annex IV of the ASEAN Agreement on Cosmetics. For decorative
cosmetic products marketed in several color shades, all coloring agents used in
the range may be listed, provided that the terms “may contain” or “+/-“ be
added.
-
All percentages of ingredients for which limits of concentration and content
are prescribed under the Annexes to the ASEAN Agreement on Cosmetics shall be
specified. A comma (“,”) may be used as a decimal separator.
-
The ingredients must be specified using the International Nomenclature of
Cosmetic Ingredients (INCI) from the latest edition of International Cosmetic
Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia,
Chemical Abstract Services, Japanese Standard Cosmetic Ingredient, and Japanese
Cosmetic Ingredients Codex. Botanicals and extract of botanicals should be
identified by its genus and species (the genus may be abbreviated). For
ingredients of animal origin, scientific name of the animal must be accurately
stated.
The
following shall not, however, be regarded as ingredients of a cosmetic product:
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Impurities in the raw materials used.
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Subsidiary technical materials used in the preparation but not present in the
final products.
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d) Language
used in the notification shall be either Vietnamese or English. Details in
Section 3 (Intended uses), Section 7 (Particulars of local company responsible
for placing the cosmetic product in the market), Section 8 (Particulars of
person representing the local company), and Section 9 (Particulars of importer)
in the notification must be written in Vietnamese or both Vietnamese and
English.
2. Notified
data (soft copy of the notification): An organization or individual may submit
notified data specified under clause 1 Article 4 of this Circular by any of the
following methods:
a) In
person: The organization or individual notifying the cosmetic product in their
name shall send a document to the Drug Administration of Vietnam under the
Ministry of Health to obtain an account for access to the cosmetic management
database and make declaration directly on the database. The notification
submitted to the competent state management agency must be printed from that
database.
b) Access
the website of Drug Administration of Vietnam, download the template for
notification of cosmetic product (Annex No. 01-MP), fill in the template as per
the law and save it on an electronic storage device (USB, CD-ROM, etc.). The
notification submitted to the competent state management agency must be printed
from that database.
The
organization or individual notifying the cosmetic product in their name must be
fully responsible for conformity of information in the notification of cosmetic
product (which bears signatures and seals) with the notified data (soft copy)
declared or submitted to the management agency.
Article 6. Regulations on power of attorney
1. Language
used must be Vietnamese, English or both.
2. A power
of attorney must fully contain following information:
a) Name and
address of the manufacturer; in case the authorizing party is a product owner,
clearly specify name and address of the owner and name and address of the
manufacturer;
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c) Scope of
authorization (notifying and distributing cosmetic products in Vietnam in their
name);
d)
Authorized brand or name of the authorized product;
dd)
Duration of authorization;
e)
Manufacturer’s or product owner’s undertaking to provide adequate product
information file (PIF) to the organization or individual responsible for
placing products in Vietnamese market;
g) Name, title
and signature of representative of the authorizing party.
Article 7. Procedures for receiving and processing cosmetic
product declaration dossiers
1. The
cosmetic product notification dossier shall be prepared in 01 set and submitted
in person or by post to the following competent state management agencies:
a) For
imported cosmetic products: the organization or individual responsible for
placing the product in the market shall submit the cosmetic product declaration
dossier to Drug Administration of Vietnam under the Ministry of Health.
b) For
domestically manufactured cosmetics: the organization or individual responsible
for placing the product in the market shall submit the cosmetic product
declaration dossier to the Department of Health the province where the factory
is located. A domestic product manufactured and packed from an imported
semi-finished product shall be regarded as a domestically manufactured cosmetic
product.
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The
introduction of cosmetics from Commercial and Industrial Zone of Moc Bai Border
Gate Economic Zone of Tay Ninh Province to other functional zones within Moc
Bai Border Gate Economic Zone of Tay Ninh Province or to domestic market for
trade; the introduction of cosmetics from Lao Bao Special Commercial – Economic
Zone of Quang Tri Province to domestic market for trade, such cosmetics must be
notified at the Drug Administration of Vietnam under the Ministry of Health
according to this Circular (the organization or individual notifying these
cosmetic products in their name must be licensed to trade cosmetics in Vietnam
and situated beyond these 2 zones).
2. Process
the cosmetic product notification dossier:
a) Within
03 working days from the date on which adequate dossier and fees are received,
the competent state management agency shall issue a cosmetic product
notification number.
b) In case the notification dossier fails to meet the
regulations of this Circular, within 05 working
days from the date on which the dossier is received, the receiving authority
shall inform the applicant in writing of the unmet regulations for amendment or
supplementation (specify the unmet regulations).
Supplementary
documents include:
- Written
explanation for the amendment or supplementation provided
by the organization or individual notifying cosmetics in their name;
- A
notification of cosmetic product enclosed with a soft copy thereof or other
documents amended or supplemented.
Within 05
working days from the date on which a supplementary dossier meeting regulations
of this Circular is received, the competent state management agency shall issue
a cosmetic product notification number.
In case the
amended or supplemented notification dossier fails to meet the regulations of
this Circular, within 05 working days from the date on which the supplementary
dossier is received, the receiving authority shall inform the applicant in
writing of its refusal to issue a cosmetic product notification number to this
product.
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Article 8. Regulations on writing cosmetic product notification
number
Cosmetic
product notification number shall consist of: ordinal number + slash + year of
issuance (last 2 digits) + slash + CBMP + dash + acronym of province, city,
Economic Zone Management Board or Drug Administration of Vietnam (QLD)
according to the Annex No. 04-MP.
For
example: 135/11/CBMP-HN means the 135th number issued by Hanoi
Department of Health in 2011.
Article 9. Changes to notified particulars
For
cosmetic products notified and issued with cosmetic product notification
number, in case of any change to the particulars specified under the Annex No.
05-MP, the organization or individual responsible for placing the product in
the market must submit an application dossier for supplementation (for
particulars that do not require a new notification), attach documents related
to the particulars to be supplemented and obtain a written consent from the
competent state agency or produce a new notification (for particulars that
require a new notification).
Article 10. Validity period of cosmetic product notification
number
A cosmetic
product notification number shall be valid for 05 years from the date of issue.
If the 05-year period expires, the organization or individual responsible for
placing the cosmetic product in the market must follow the notification
procedures again before the expiry of the cosmetic product notification number
and pay fees as prescribed.
Chapter III
COSMETIC
PRODUCT INFORMATION FILE
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Upon being
placed in the market, each cosmetic product must have a product information
file (PIF) produced according to ASEAN’s guidelines and stored by the
organization or individual responsible for placing the product in the market.
Article 12. Contents of cosmetic product information file
1. A cosmetic
product information file consists of 4 parts as follows:
a) Part 1:
Administrative documents and product summary;
b) Part 2:
Quality data of raw materials;
c) Part 3:
Quality data of finished product;
d) Part 4:
Safety and efficacy data.
Details of
a cosmetic product information file are specified under the Annex No. 07-MP.
2. Part 1
of the PIF must be presented to the inspecting authority upon request; other
parts must be presented within 15-60 days from the inspection at the request of
competent authorities if said parts are insufficient at the time of inspection.
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COSMETIC
PRODUCT SAFETY REQUIREMENTS
Article 13. Cosmetic product safety requirements
Every
organization or individual responsible of placing a cosmetic product in the market
must ensure that their product is not detrimental to human health when used
under normal condition or suitable conditions as directed, is suitable for
dosage form and information on label, instructions for use, cautions and other
information provided by the manufacturer(s) or product owner.
The
manufacturer(s) or product owner must assess the safety of each cosmetic
product according to ASEAN’s Guidelines for Safety Assessment of a Cosmetic
Product. Limits of heavy metals and microbial contaminants for cosmetic
products must satisfy ASEAN’s requirements under Annex No. 06-MP. Ingredients
present in the cosmetic formulation must meet the requirements of Annexes in
their latest editions under the ASEAN Agreement on Cosmetics (address: www.dav.gov.vn
or www.aseansec.org).
Article 14. Prohibited substances, ingredients on which
concentration and content limits are imposed and conditions of use in
formulation of cosmetic products
Organizations
and individuals must not place cosmetic products that contain the following
ingredients in the market:
1.
Substances prohibited from use in cosmetic products subject to conditions laid
down under Annex II.
2.
Ingredients listed in the first section of Annex III which are used beyond the
specified limits and outside the conditions laid down.
3. Coloring
agents other than those listed in Annex IV, section 1, with the exception of
cosmetic products containing coloring agents intended solely for hair coloring.
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5.
Preservatives other than those specified under Annex VI, section 1.
6.
Preservatives listed in Annex VI, section 1 which are used beyond the specified
limits and outside the stated conditions laid down therein, unless these
substances are used for specific purposes unrelated to their use as
preservatives.
7.
Ultraviolet filters not specified in Annex VII section 1.
8.
Ultraviolet filters specified in Annex VII, section 1 which are used beyond the
limits and stated outside the conditions laid down therein.
The
presence of traces of substances listed in Annex II in trace
amounts shall be allowed provided that such presence is
technically unavoidable in “Good manufacturing practice for cosmetics” and that
it conforms to safety requirements specified in Article 13 of this Circular.
Article 15. Marketing of cosmetic products containing the
following ingredients allowed
1.
Ingredients or raw materials listed in Annex III, section 2 within the
specified limits and under specified conditions, until the date specified under
column (g) of this Annex.
2. Coloring
agents listed in Annex IV, section 2 within the permitted limits and under the
accepted conditions, until the date specified in this Annex.
3.
Preservatives listed in Annex VI, section 2 within the permitted limits and
under the accepted conditions, until the date specified in column (f) of this
Annex. However, different concentrations of several ingredients may be used for
specific purposes apparent from the presentation of the product.
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Regulations
on use of substances under aforementioned Annexes may be changed as decided by
the ASEAN Cosmetic Committee. These regulations shall be updated automatically
and valid in Vietnam.
Chapter V
COSMETICS
LABELLING
Article 16. Cosmetic label position
1. Cosmetic
labels must be attached to goods and consumer packaging thereof in a position
where, when observed, the specified contents of the label can be easily and
fully identified without having to detach the details and parts of the goods.
2. In case
the outer packaging cannot or cannot be opened, the outer packaging must have a
label and the label must fully display the required contents.
Article 17. Size, form and contents of labels
1.
Organizations and individuals responsible for placing products in the market must
determine the size of cosmetic labels themselves, but must ensure that the
information on labels must be easy to read with the naked eye. The content of
the label and auxiliary label (if any) must be honest, clear and accurate, and
reflect the true characteristics of the product.
2. The
color of letters, numbers, drawings, images, signs and symbols presented on
cosmetic labels must be clear. The color of letters and numbers must contrast
with the background of the label.
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1. Cosmetic
product labels must comply with ASEAN’s cosmetic labeling requirements. The
following information must be shown on a product label:
a)
The name of the cosmetic product and its function, unless it is clear from the
presentation of the product;
b)
Instructions on the use of the cosmetic product, unless it is clear from the
product presentation;
c)
Full ingredient listing: The ingredients shall be specified using the
international nomenclature from the latest edition of the references mentioned
in point c clause 1 Article 5 of this Circular (the percentage of ingredients
is not required to be specified);
d)
The name of country of manufacture;
dd)
Name and address of the organization or individual responsible for placing the
product in the market (fully written in Vietnamese according to the business
registration certificate or investment license);
e)
The contents given by weight or volume, in either metric or both metric and
imperial system;
g)
The manufacturing batch number;
h)
The manufacturing or the expiry date of the product in clear terms (e.g.
day/month/year). The date shall be clearly expressed and shall consist either
of the month and year or the day, month and year in that order. It should be
preceded by the words “expiry date” or “best before”. If necessary, this
information shall be supplemented by an indication of the conditions which must
be satisfied to guarantee the stated durability.
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i) Special
precautions, especially those listed in the column “Conditions of use and
warnings which must be printed on the label” in the ingredient Annexes of ASEAN
Agreement on Cosmetics, which must appear on the label as well as any special
precautionary information on the cosmetic products.
2. In cases
where the size, shape or nature of the container or package does not permit the
particulars laid down in clause 1 of this Article to be displayed on the
original label, these mandatory contents must be written on the auxiliary label
attached to the cosmetic product and the cosmetic label must indicate where
those contents are written.
The
following particulars at least shall appear on immediate packaging:
a) The name
of the cosmetic product;
b) The
manufacturing batch number.
Article 19. Language presented on cosmetic labels
Details
under Article 18 hereof must be presented in English or Vietnamese; information
under points b, dd, and i clause 1 of Article 18 must be specified in
Vietnamese.
Article 20. Other contents displayed on cosmetic labels
Organizations
and individuals may specify other contents on cosmetic labels. Additional
contents must not contradict regulations and law, must be truthful, accurate
and true, and must reflect the nature of the goods, must not obscure or distort
the mandatory contents on cosmetic labels.
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COSMETIC
ADVERTISING
Article 21. Regulations on cosmetic advertising
1. Cosmetic
advertising may be conducted through mass media such as television, radio,
websites, Internet, books, newspapers, magazines, leaflets, billboards,
posters, aerial objects, underwater objects or other advertising media, by
cosmetic traders themselves or through sponsorship or authorization of another unit,
and through the organization of seminars, dissemination of information and
introduction of cosmetic products.
2. A unit
may only advertise cosmetic products or organize a cosmetic product launch
seminar or event when it has obtained an Acknowledgement of the application
dossier for registration of cosmetic advertising or for organization of
cosmetic launch seminar/event in accordance with law.
3. The
contents of cosmetic advertising must be consistent with documents evidencing
the safety and efficacy of the cosmetics and must comply with the ASEAN
Cosmetic Claim Guideline.
Article 22. Contents of cosmetic advertising, seminars and events
for cosmetic launch
Contents of
cosmetic advertising, seminars and events for cosmetic launch must fully
include:
1. Name of
the cosmetic;
2. Product
claims and uses (stating the principal claims and uses of the cosmetic if they
are yet to be indicated in the product name);
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4.
Precautions for use (if any).
Article 23. Advertising of cosmetics on television and radio
For
cosmetic advertising on television and radio, the contents specified in clauses
1, 3 and 4 of Article 22 must be read aloud clearly. Where the said contents
are displayed on screen in text format, the display speed must be appropriate
and the advertising font size must be sufficiently large to ensure clarity and
readability.
Article 24. Advertising in newspapers and leaflets
For
advertising in newspapers and leaflets, the following information must be
printed at the bottom of the first page of the cosmetic advertising material:
(a) the number of the Acknowledgement of the application dossier for
registration of cosmetic advertising issued by the Department of Health; (b)
date ... month ... year ... on which the valid dossier was received as stated
in the Receipt.
Article 25. Application dossiers for registration of cosmetic
advertising and for organization of cosmetic launch seminar/event
1. An application
dossier for registration of cosmetic advertising or for organization of
cosmetic launch seminar/event shall comprise the following documents:
a) An
application form for registration of cosmetic advertising or for organization
of cosmetic launch seminar/event (Annex No. 10-MP);
b) A copy
of the issued notification of cosmetic product (bearing the seal of the
organization or individual applying for advertising);
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d) A power
of attorney from the organization or individual making the cosmetic product notification
to the organization or individual applying for registration of cosmetic
advertising or for organization of cosmetic launch seminar/event that is not
the organization or individual that made the cosmetic product notification);
dd) An
explanatory document to the product claims and uses in case the contents of
advertising or contents presented at the seminar or event for the cosmetic
launch contain the product claims and uses other than those stated in the
notification of cosmetic product;
e) 02 advertising
scripts (the scripts must clearly describe the intended images, narration and
music) or 02 advertising samples intended for release (applicable to the
application dossier for registration of cosmetic advertising) or materials
intended to be displayed or distributed at the cosmetic launch seminar/event
(applicable to the application dossier for organization of cosmetic launch
seminar/event). The dossier must bear the joint-page-seal of the organization
or individual applying for registration of cosmetic advertising or for
organization of cosmetic launch seminar/event.
2.
Instructions on preparation of an application dossier for registration of
cosmetic advertising or for organization of cosmetic launch seminar/event:
a) An
application dossier for registration of cosmetic advertising may be prepared
for one or more products to be advertised through one or more different mass
media.
An
advertising sample or cosmetic advertising script may be prepared for one or
more different products.
b) An
application dossier for organization of cosmetic launch seminar/event may be
prepared for one or more products on which the seminar or event is to be
organized at one or more locations within a province or city.
Article 26. Authority to receive and process application dossiers
for registration of cosmetic advertising and for organization of cosmetic
launch seminar/event
1. Before
advertising a cosmetic, an organization or individual shall submit 01
application dossier for registration of cosmetic advertising in accordance with
applicable regulations to the Department of Health of the province where the
head office of the organization or individual making the cosmetic product
notification is located. The envelope containing the dossier must be clearly
marked with the words "Hồ sơ đăng ký quảng cáo mỹ phẩm"
("Application dossier for registration of cosmetic advertising").
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3.
Departments of Health of provinces and central-affiliated cities (except for
forms of advertising carried out in accordance with Joint Circular No.
06/2007/TTLT/BVHTT-BYT-BNN-BXD dated February 28, 2007 of the Ministry of
Culture and Information, the Ministry of Health, the Ministry of Agriculture
and Rural Development and the Ministry of Construction providing guidelines on
procedures for issuance of licenses for advertising under the single-window
system) shall receive and process application dossiers for registration of
cosmetic advertising and for organization of cosmetic launch seminar/event.
Article 27. Sequence and procedures for issuance of
Acknowledgements of application dossiers for registration of cosmetic
advertising and for organization of cosmetic launch seminar/event
1. After
receiving a valid application dossier for registration of cosmetic advertising
or for organization of cosmetic launch seminar/event in accordance with this
Circular and the fee in accordance with applicable regulations, the Department
of Health shall send the applicant an Acknowledgement of application dossier
for registration of cosmetic advertising or for organization of cosmetic launch
seminar/event (Annex No. 11-MP) enclosed with a satisfactory advertising sample
or script (applicable to the application dossier for registration of cosmetic
advertising). The date stated on the Acknowledgement shall be the date on which
the Department of Health receives a sufficient and valid dossier. Within 10
working days from the date of receipt of the dossier, if the Department of
Health does not issue a written request for amendment or supplementation, the
applicant is entitled to advertise the cosmetic or organize the cosmetic launch
seminar or event in accordance with the registered contents.
2. Where
the dossier is not valid in accordance with this Circular, the Department of
Health shall issue a written notice requesting the applicant to supplement and
complete the dossier.
a) The
written notice must clearly specify the documents and contents requiring
amendment or supplementation.
b) The
applicant shall amend and supplement the dossier in accordance with the written
request for amendment or supplementation and submit it to the Department of
Health. Once the applicant has fully supplemented the dossier, the Department
of Health shall issue an Acknowledgement of the dossier, and the date stated on
the Acknowledgement shall be the date on which the Department of Health
receives the valid supplementary dossier as requested. Within 10 working days
from the date of receiving the amended and supplemented advertising contents,
if the Department of Health does not issue a written request for further
amendment or supplementation, the applicant is entitled to advertise the
cosmetic or organize the cosmetic launch seminar or event in accordance with
the amended contents.
c) Where
the supplementary dossier fails to meet the requirements specified in the
written request for amendment or supplementation, the Department of Health
shall notify the applicant that it is not permitted to advertise the cosmetic
or organize the cosmetic launch seminar or event in accordance with the
registered contents. In this case, if the applicant wishes to advertise the
cosmetic or organize the cosmetic launch seminar or event, it shall submit a
new dossier; the registration and dossier appraisal procedures shall be carried
out again from the beginning and fees shall be paid as prescribed.
d) Within
02 months from the date on which the Department of Health sends the applicant a
written request specifying the contents requiring supplementation, if the
Department of Health does not receive a document accompanied by the
supplementary dossier, the submitted application dossier for registration of
cosmetic advertising or for organization of cosmetic launch seminar/event will
be invalidated.
Article 28. Fees for appraisal of information and advertising
contents
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2. The fee
for appraisal of an application dossier for organization of cosmetic launch
seminar/event (fee for appraisal of information and advertising contents) shall
be charged in accordance with applicable regulations based on the number of
products corresponding to 01 notification of cosmetic product to which a number
has been issued (regardless of the number of sessions of the seminar or event
and the number of locations where the seminar or event is organized).
Article 29. Advertising of cosmetics in other localities
After
receiving the Acknowledgement of the application dossier for registration of
cosmetic advertising, a unit wishing to advertise a cosmetic through
advertising media in a locality other than the locality where the application
dossier for registration of cosmetic advertising was submitted shall, at least
03 working days prior to advertising, send a written notice enclosed with
certified true copy of the Acknowledgement of the application dossier for
registration of cosmetic advertising and the entire relevant registered
advertising contents (script or advertising sample) to the Department of Health
of the locality where the advertising is intended to take place.
Article 30. Change and supplementation of contents of cosmetic
advertising and cosmetic launch seminars and events
1. A unit
applying for registration of cosmetic advertising or organization of a cosmetic
launch seminar/event shall submit an application dossier for supplementation to
the Department of Health that issued the Acknowledgment of the dossier where
any of the following contents is changed:
a) Name and
address of the organization or individual responsible for placing the product
in the market without change of the number of the business registration certificate
or investment registration certificate;
b) Name or
address of the unit applying for registration of cosmetic advertising or
organization of a cosmetic launch seminar/event, without change of the number
of the business registration certificate or investment registration
certificate;
c) Official
location or time of organization of the cosmetic launch seminar/event compared
with the location or time previously registered.
2. The supplementary
dossier shall comprise a written request for amendment or supplementation and
documents relevant to the amendments or supplements.
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4. The
Department of Health shall process the supplementary dossier within 10 working
days from the date of receipt of a complete valid dossier.
Article 31. Cases where contents of cosmetic advertising and
cosmetic launch seminars and events cease to be valid
1. Contents
of cosmetic advertising and cosmetic launch seminars and events shall cease to be
effective in the following cases:
a) The
marketing authorization number, the number of the acknowledgment of
notification of cosmetic product quality standard or the number of the
acknowledgment of notification of cosmetic product has expired.
b) The cosmetic
is subject to a recommendation by a competent state management agency to cease
its use or is subject to a recall.
c) There
are changes to information affecting the safety and quality of the cosmetic.
2. The unit
whose contents of cosmetic advertising or cosmetic launch seminar or event have
ceased to be valid shall notify relevant authorities and advertisement
publishers to immediately cease the publishing of information about and the
advertising of such cosmetic.
Chapter VII
COSMETIC
IMPORT AND EXPORT
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Cosmetic
export shall be conducted at customs authorities as per applicable law and
requirements of importing countries.
Article 33. Application dossiers and procedures for issuance of
CFS for cosmetics domestically produced for export
1. An
application dossier for issuance of a CFS shall comprise:
a) An
application for issuance of CFS (Annex IV to the Prime Minister’s Decision No.
10/2010/QD-TTg dated February 10, 2010), which is duly and validly completed;
b) A copy
of the notification of cosmetic product to which the competent agency has
issued a number (the copy shall bear the seal of the trader applying for CFS).
2. The
issuance of CFS to domestically produced for export shall comply with Chapter
II of the Prime Minister’s Decision No. 10/2010/QĐ-TTg dated February 10, 2010,
and the following provisions:
a) A
cosmetic domestically produced for export shall be granted a CFS when it has
been issued with a cosmetic product notification number by a competent state
management agency.
b) An
exporter shall register its exporter dossier with the Department of Health of
the province where the cosmetic manufacturing establishment is located and
carry out procedures for the issuance of a CFS for exported cosmetic products.
c) Each CFS
may be issued to 01 or more products (Form of the CFS form provided in Annex
No. 12-MP) and shall be valid for 02 years from the date of issuance.
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4.
Departments of Health of provinces and central-affiliated cities are agencies
competent to issue and manage CFS for exported cosmetics manufactured in their
provinces (where the cosmetic manufacturing establishment is located).
Article 34. Applications and procedures for issuance of
Certificate of compliance with “Cosmetic Good Manufacturing Practice” of ASEAN (CGMP-ASEAN)
serving export demands
1. Any
manufacturer that wishes to apply for the Certificate of compliance with
“Cosmetic Good Manufacturing Practice” of ASEAN (CGMP-ASEAN) to serve export
shall submit an application dossier for inspection
to the Drug Administration of Vietnam under the Ministry of Health. The
application dossier includes:
a) An
application for inspection of “Cosmetic Good Manufacturing Practice” (Annex No.
13-MP);
b) A copy
of the business registration certificate or investment license;
c)
Organizational chart and personnel of the establishment (the organizational
chart must specify names, titles and expertise of officials in charge of each
section), working progress and experience in assigned tasks of officials in
charge of each section (manufacturing, quality inspection, quality assurance,
warehousing);
d) Training
program, assessment of results of training in “Cosmetic Good Manufacturing
Practice” at the manufacturing establishment;
dd) Diagrams
of the factory location and factory design (including: general site plan;
employee’s path plan; fuel, packaging, semi-finished product and finished
product’s path plan; waste treatment system diagram);
e) List of
existing equipment of the factory (including manufacturing equipment and
equipment for cosmetic quality inspection) must display equipment name, year of
manufacture, country of manufacture and status of equipment;
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h)
“Cosmetic Good Manufacturing Practice” self-inspection record (the record must
specify the time of inspection, composition of inspectorate for
self-inspection, objectives of self-inspection, results of self-inspection and
proposed time and measures for correcting deficiencies).
2.
Authority to receive and process the application dossier:
The Drug
Administration of Vietnam under the Ministry of Health shall consider the
application, formulate a plan and issue a decision to establish an
inspectorate, and notify the establishment at least 10 days prior to the
inspection.
3. The
Certificate of compliance with “Cosmetic Good Manufacturing Practice” shall be
valid for 03 years from the date of issue.
4. The
manufacturer (hereinafter referred to as “GMP applicant”) must pay fees for
appraisal of standard and conditions for cosmetic manufacture in accordance
with applicable regulations.
Article 35. Cosmetic import
1. Cosmetic products to which the Drug Administration of Vietnam
under the Ministry of Health has issued valid cosmetic product notification
number may be imported into Vietnam. Import procedures shall be carried out at
customs authorities in accordance with current regulations. When
carrying out import procedures, enterprises shall present to the customs
authority the notification of cosmetic product to which a number has been
issued by the Drug Administration of Vietnam under the Ministry of Health.
2. Cosmetic
import in special cases (cosmetic product is not required to be notified
according to this Circular):
a) Any
organization or individual that imports cosmetics for research or testing must
send the order for import of cosmetics for research or testing to the Drug
Administration of Vietnam under the Ministry of Health (Annex No. 14-MP). The
maximum quantity for each product is 10 specimens.
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Cosmetic
products imported for research or testing must be used for their intended
purposes and shall not be placed on the market for circulation.
b) An
organization or individual receiving a cosmetic as a gift or donation shall
follow import procedures at the customs authority as per regulations. Total value
of cosmetics received each time must not exceed duty-free product value as per
applicable laws.
Cosmetic
samples imported as gifts and donations must not be placed in the market for
circulation.
c) For
organizations and individuals importing cosmetics for display at fairs,
exhibitions and other cases of temporary import for re-export, it is required
to follow procedures for issuance of license for temporary import for re-export
of Ministry of Industry and Trade as per applicable regulations.
Chapter VIII
COSMETIC
SAMPLING FOR QUALITY INSPECTION
Article 36. Sampling principles
1. Cosmetic
sampling for quality inspection or control shall conform to random sampling
principles and must be performed in different spots of the shipments.
2. The quantity
of samples to be collected for analysis and storage depends on inspection
requirements, quality standards and testing methods as long as it is sufficient
for three analyses or sufficient for the adoption of testing methods that give
accurate and reliable results.
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4. Make a
cosmetic sampling record using the Form in the Annex No. 09-MP: The cosmetic
sampling record should explicitly specify the name of the product,
manufacturing batch number, date and place of sampling, notes on abnormalities
during the sampling, name and signature of the sampler and representative of
the establishment where the sample was taken, witness (where necessary). The
record should be made into 03 copies, which are kept at the establishment where
the sample was taken, testing authority and cosmetic quality inspecting
authority respectively.
Article 37. Rights and responsibilities of samplers
1. Present
inspector cards or quality controller cards or letters of introduction or
decisions on establishment of inspectorate signed by heads of cosmetic quality
inspecting authorities when performing tasks.
2. Request
establishments having samples to present documents related to origin, quantity
and quality of cosmetic batches that are sampled, and work out sampling
methods, amount of analytical and retention samples collected from cosmetic
batches during the sampling.
3. Examine
and collect samples from any package in cosmetic shipments upon having any suspicion
regarding product quality and safety.
4. Be
legally responsible for techniques and legal procedures during sampling,
transport and transfer to testing authorities.
Article 38. Sample transport and transfer
1. After
sampling is finished, a sampler must transport and transfer collected samples
and cosmetic sampling record to the inspecting authority. In special cases,
samples can be sent to the inspecting authority by post.
2.
Collected cosmetic samples must be packed in appropriate packaging and transported
via appropriate means to ensure that samples are stored according to
regulations to avoid damage and irreversible deformation during transport.
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1. Quality
inspection results are legally valid for the whole cosmetic product batches as
long as cosmetic samples collected by state agencies competent to inspect
sampling quality represent the whole cosmetic product batches and are analyzed
in accredited laboratories.
2. In case
cosmetic samples are sent to state-owned quality inspecting authorities by
organizations and individuals for quality inspection, quality inspection
results are only valid for sent samples.
Article 40. Costs of cosmetic sampling and testing for
determination of cosmetic quality
1. Costs of
cosmetic sampling and cosmetic sample testing for quality inspection during
manufacturing, concocting and circulating on the market shall be incurred by
the quality inspecting authority that decide on sampling and sample testing according
to the Joint Circular No. 28/2010/TTLT-BTC-BKHCN dated March 03, 2010 of
Ministry of Finance and Ministry of Science and Technology providing guidelines
on management and use of costs of state inspection of product and goods
quality.
2. In case
the cosmetic quality inspecting authority concludes that the tested cosmetic
samples fail to satisfy quality standards, the organization or individual
responsible for placing the product in the market must reimburse the cosmetic
quality inspecting authority for the costs of cosmetic sampling and cosmetic
sample testing according to Article 10, Article 12, Article 14, Article 16 and
Article 41 of the Law on Quality of Products and Goods 2007 and Joint Circular
No. 28/2010/TTLT-BTC-BKHCN dated March 03, 2010 of Ministry of Finance and
Ministry of Science and Technology providing guidelines on management and use
of costs of state inspection of product and goods quality.
3. In case
there is a complaint or denunciation about the quality of the cosmetic and the
inspecting authority concludes that such compliant or denunciation is
incorrect, the person filing the compliant or denunciation must reimburse the
inspecting authority for the costs of cosmetic sampling and cosmetic sample
analysis as specified in clause 1 of this Article.
4. The
costs of cosmetic sampling for quality inspection and costs of cosmetic sample
testing are included in the estimate of operating costs of the authority in
charge of state inspection of cosmetic quality as prescribed in the Joint Circular
No. 28/2010/TTLT-BTC-BKHCN dated March 03, 2010 of Ministry of Finance and
Ministry of Science and Technology providing guidelines on management and use
of costs of state inspection of product and goods quality.
Chapter IX
EXAMINATION,
INSPECTION AND HANDLING OF VIOLATIONS
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1. Cosmetic
quality inspecting authorities:
a) Central
cosmetic quality inspecting authority is the Drug Administration of Vietnam
under the Ministry of Health. The Drug Administration of Vietnam shall direct
the testing system nationwide. During state inspection of cosmetic quality, the
Drug Administration of Vietnam shall cooperate with the inspectorate of
Ministry of Health, the National Institute of Drug Quality Control, Institute of
Drug Quality Control of Ho Chi Minh City, Departments of Health of provinces
and central-affiliated cities in implementing and supervising post-marketing
activities for cosmetic products.
On the
basis of cosmetic testing results given by state-owned testing authorities, the
Drug Administration of Vietnam under the Ministry of Health shall conclude
quality of cosmetics nationwide.
b) Local
cosmetic quality inspecting authorities are Departments of Health of provinces
and central-affiliated cities. Departments of Health of provinces and
central-affiliated cities shall carry out post-marketing activities for
domestically manufactured cosmetics and imported cosmetics circulated in
provinces and handle issues concerning cosmetic quality as prescribed by law. Monitor
and produce statistics on management of cosmetic quality in provinces.
Conclude
cosmetic quality on the basis of cosmetic testing results given by state-owned
testing authorities in provinces.
2.
State-owned cosmetic testing system includes:
a) At central
level: National Institute of Drug Quality Control, Institute of Drug Quality
Control of Ho Chi Minh City;
b) At local
level: Drug and Cosmetic Quality Control Centers of provinces and
central-affiliated cities.
3. Heads of
cosmetic quality control authorities shall assume legal responsibility for
their conclusion on cosmetic quality control results.
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1. Periodic
examination and inspection: Periodic examination and inspection shall be
notified to inspected entities by competent authorities to enable inspected
entities to prepare for examination and inspection in advance.
2. Surprise
examination and inspection: Surprise examination and inspection shall be
conducted when any product that fails to satisfy quality standards or comply
with regulations on circulation is found or there is any customer’s complaint.
In an emergency, competent authorities have the rights to conduct examination
and inspection without advance notice.
Article 43. Contents of examination and inspection
1.
Examination and inspection of compliance with law on cosmetic manufacturing and
trading:
a)
Compliance with principles and standards of “Cosmetic Good Manufacturing
Practice” of ASEAN (CGMP-ASEAN) or equivalent accredited by the ASEAN Cosmetic
Committee;
b) Cosmetic
product labeling;
c) PIF
according to ASEAN’s regulations;
d) Cosmetic
advertising.
2.
Examination and inspection of settlement of disputes, complaints and
denunciations regarding quality and other issues related to cosmetics (if any).
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Article 44. Order of priority in post-marketing inspection and
surveillance
Cosmetic
post-marketing inspection and surveillance conducted in a concentrated manner
at the premises of importers, distributors and manufacturers. The order of
priority in cosmetic post-marketing inspection and surveillance depends on type
of products, origin, brand, company trademark, product formula according to
ASEAN’s guidelines on post-marketing inspection and surveillance (Annex No.
08-MP).
Article 45. Cosmetic circulation suspension and recall of
cosmetics
1. A
cosmetic shall be subject to circulation suspension and recall in any of the
following cases:
a) The
cosmetic is circulated without being issued with cosmetic product notification
number declaration by a competent state management agency;
b) The
cosmetic fails to satisfy quality standards and is unsafe for users;
c) Formula
of the cosmetic circulated is not consistent with that notified;
d) The
cosmetic circulated contains substances prohibited from use in cosmetics,
substances whose concentrations exceed the permitted limits;
dd) The
circulated cosmetic which has a label that displays uses inconsistent with
those specified in the notification dossier or fails to comply with regulations
on product labeling of this Circular may be subject to circulation suspension
and recall depending on the degree of violation;
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g) The
cosmetic has expired or exceeded the manufacturer's recommended shelf life;
h) The
cosmetic is counterfeit, smuggled or of unknown origin or its packaging is
incomplete;
i) The
organization or individual responsible for placing the product in the market
submits an application dossier for voluntary recall of the cosmetic.
2. The
authority to issue a decision on violating cosmetic recall:
a) The Drug
Administration of Vietnam under the Ministry of Health shall issue decisions on
violating cosmetic recall nationwide.
b)
Departments of Health of provinces and central-affiliated cities, Border Gate
Economic Zone Management Board (Tay Ninh Province), Quang Tri Economic Zone
Management Board shall notify the Drug Administration of Vietnam under the
Ministry of Health of violating cosmetic recall as per the law in local
administrative divisions and submit a report thereon to the Drug Administration
of Vietnam.
Article 46. Revocation of cosmetic product notification number
1. A
cosmetic product notification number is revoked in any of the following
cases:
a) The
state management agency for cosmetic quality concludes that there are 2 batches
of substandard circulated cosmetic;
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c) Label of
the circulated cosmetic displays incorrect origin;
d) Label of
the circulated cosmetic displays incorrect innate functions of the product;
dd) The
cosmetic is unsafe for users;
e) The cosmetic
circulated contains substances prohibited from use in cosmetics, substances
whose concentrations exceed the permitted limits;
g)
Competent state agencies conclude that the cosmetic violates intellectual
property rights or imitates labels of other products licensed for sale;
h) The
cosmetic is prohibited from sale in a home country;
i) The
organization or individual responsible for placing the product in the market
submits an application dossier for revocation of the cosmetic product
notification number;
k) There is
no PIF presented to competent agencies according to Article 12 hereof;
l)
Documents are forged, counterfeit seals are used or signatures or seals of
Vietnamese or foreign authorities or of the manufacturer(s) or product owner
are forged;
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2. The
authority to issue decisions on revocation of cosmetic product notification
number:
a) The Drug
Administration of Vietnam under the Ministry of Health shall issue decisions on
revocation of number of notification of domestically manufactured cosmetic
product issued with a number by the Drug Administration of Vietnam before April
25, 2009 and imported cosmetics nationwide.
b)
Departments of Health of provinces and central-affiliated cities shall issue
decisions on revocation of number of notification of locally manufactured
cosmetic product which they issued
c) Border
Gate Economic Zone Management Board (Tay Ninh Province) and Quang Tri Economic
Zone Management Board shall issue decisions on revocation of number of
notification of cosmetic product which they issued.
Article 47. Cases of ceasing to receive cosmetic product
notification dossiers, application dossiers for registration of cosmetic
advertising and for organization of cosmetic launch seminars and events
1.
Competent state management agencies shall cease to review and receive the
cosmetic notification dossier 06 months if an organization or individual
commits any of the following acts:
a) Trading
illegally imported cosmetics, counterfeit cosmetics, cosmetics of unclear
origin;
b) Trading
cosmetics without being issued with cosmetic product notification number by
competent state management agencies;
c) Failing
to recall violating cosmetics as notified by competent state management
agencies;
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dd)
Manufacturing or trading cosmetics containing substances prohibited from use in
cosmetics or substances whose concentrations exceed the permitted limits with
regard to substances on which concentration limits are imposed as per
applicable law;
e) Using
raw materials prohibited from circulation by the country of manufacture for
cosmetic production;
g)
Importing or trading cosmetics or raw materials for cosmetic production
prohibited from circulation by the country of manufacture;
h)
Manufacturing or trading cosmetics whose formula is inconsistent with that
notified;
i) Forging
documents, using counterfeit seals or forging signatures or seals of Vietnamese
or foreign authorities or of the manufacturer(s) or product owner;
k)
Untruthfully declaring particulars in the notification of cosmetic product;
l) Failing
to obtain PIF stored by enterprises according to regulations.
2.
Competent state management agencies shall cease to review and receive the
application dossier for registration of cosmetic advertising or for
organization of cosmetic launch seminar/event for 06 months if an organization
or individual commits any of the following acts:
a)
Advertising cosmetics or organizing a cosmetic launch seminar or event without
an acknowledgement of application dossier for cosmetic advertising or
organization of cosmetic launch seminar/event issued by a competent state
management agency as prescribed by law;
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c)
Advertising a cosmetic in a way that can cause consumers to mistake it as a
medicine; advertising a cosmetic by using the credit, name, symbol, images or
credentials of medical or pharmaceutical organizations or health officials;
advertising a cosmetic with claims and uses that lack scientific evidence.
3.
Competent state management agencies shall cease to review and receive the
cosmetic product notification dossier, application dossier for registration of
cosmetic advertising or for organization of cosmetic launch seminar or event if
an organization or individual does not submit annual report on its business
performance as prescribed.
Past the
period of ceasing to review and receive dossier/application, competent state
management agencies shall, after all violations have been fully rectified and
report is made, continue to review and receive the cosmetic product
notification dossier, application dossier for registration of cosmetic
advertising or for organization of cosmetic launch seminar/event.
Chapter X
RESPONSIBILITIES OF COSMETIC MANUFACTURERS, TRADERS AND IMPORTERS
AND RIGHTS OF CONSUMERS
Article 48. Responsibilities of organizations and individuals
manufacturing, trading and importing cosmetics for circulation in Vietnamese
market
1.
Organizations and individuals responsible for placing cosmetic products in the
market must be totally responsible before the law for the particulars specified
in notifications of cosmetic product and be totally responsible for the safety,
efficacy and quality of products in order to guarantee that circulated products
satisfy all requirements of the ASEAN Agreement on Cosmetics and Annexes
attached thereto.
2.
Organizations and individuals responsible for placing cosmetic products in the
market shall monitor, discover and recall substandard cosmetics, abide by
recall notifications issued by competent state management agencies, report
cosmetic recalls to competent state agencies; promptly resolve customers’
complaints about cosmetic quality and provide compensation for damage caused to
customers as prescribed by law. At the same time, reimburse buyers and costs
incurred during product storage, transportation and circulation.
3. In case
adverse events that seriously damage consumer’s life stem from cosmetic product
quality are found, organizations and individuals responsible for placing
cosmetic products in the market must submit reports to the Drug Administration
of Vietnam under the Ministry of Health using Form under Annex No. 18-MP within
07 days from the date on which they are first informed about these adverse
events. Detailed reports on these adverse events must be submitted to the Drug
Administration of Vietnam under the Ministry of Health within the next 08 days.
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5. Cosmetic
manufacturers must implement and comply with principles and standards of
“Cosmetic Good Manufacturing Practice” of ASEAN (CGMP-ASEAN).
6. Cosmetic
traders must satisfy the requirements laid down by competent state agencies for
examination and inspection of cosmetic product quality, recall violating
cosmetics and have the rights to file complaints about conclusions and forms of
penalties according to regulations and law on complaints and denunciations.
7.
Organizations and individuals responsible for placing products in the market
must conform to Vietnamese regulations and laws on intellectual property. Once
state competent agencies issue conclusions on brand and industrial design that
violate intellectual property rights, organizations and individuals must cease
manufacturing, trade and import to replace brand and industrial design as per
regulations and shall reimburse consumers and deal with consequences (if any).
Article 49. Rights of cosmetic consumers
Consumers
have the rights to be informed about cosmetics, file complaints and
denunciations and request cosmetic traders to compensate for damage as per the
law caused by the use of substandard and unsafe cosmetics manufactured and
circulated.
Chapter XI
ORGANIZING IMPLEMENTATION
Article 50. Information and reporting regime
1. The Drug
Administration of Vietnam under the Ministry of Health shall update and
implement regulations related to the ASEAN Agreement on Cosmetics on its
website of Drug Administration of Vietnam (address: www.dav.gov.vn).
Regularly inform relevant units, cosmetic manufacturers and traders about
changes to technical criteria decided by the ASEAN Cosmetic Committee while
cooperate in implementing these changes and decisions in Vietnam. All decisions
on cosmetic management approved by the ASEAN Cosmetic Committee shall be
applied in Vietnam.
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3. On June
30 and December 31 each year, Departments of Health of provinces and
central-affiliated cities, Border Gate Economic Zone Management Board (Tay Ninh
Province) and Quang Tri Economic Zone Management Board shall submit reports on
quality management and post-marketing of cosmetics in localities, reports on
issuance of cosmetic product notification number (Annex No. 15-MP), reports on
issuance of acknowledgment of application dossier for registration of cosmetic
advertising or for organization of cosmetic launch seminar/event (Annex No.
16-MP) to the Drug Administration of Vietnam under the Ministry of Health.
4. On
January 30 each year, organizations and individuals responsible for placing
products in the market must send reports on their business performance of the
previous years to the Drug Administration of Vietnam under the Ministry of
Health and local Departments of Health (Annex No. 17-MP).
Article 51. Forms and Annexes attached hereto
1. Notification
of cosmetic product: Annex No. 01-MP.
2. Guiding
documents on notification of cosmetic product: Annex No. 02-MP.
3. ASEAN
Cosmetic Claim Guideline: Annex No. 03-MP.
4. Acronyms
of provinces, central-affiliated cities and some economic zone management
boards: Annex No. 04-MP.
5. Changes
after cosmetic product notification: Annex No. 05-MP.
6. ASEAN
Guidelines on limits of heavy metals and microbial contaminants
for cosmetic products: Annex No. 06-MP.
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8. ASEAN
Guidelines on cosmetic post-marketing surveillance: Annex No. 08-MP.
9. Form of
Record on cosmetic sampling for quality inspection: Annex No. 09-MP.
10. Form of
Application for registration of cosmetic advertising or for organization of
cosmetic launch seminar or event: Annex No. 10-MP.
11. Form of
Acknowledgement of application dossier for cosmetic advertising or organization
of cosmetic launch seminar/event: Annex No. 11-MP.
12. Form of
Certificate of Free Sale (CFS): Annex No. 12-MP.
13. Form of
Application for inspection for “Cosmetic Good Manufacturing Practice”: Annex
No. 13-MP.
14. Form of
Import order for research and testing: Annex No. 14-MP.
15. Form of
List of cosmetics issued with cosmetic product notification number: Annex No.
15-MP.
16. Form of
List of cosmetics issued with Acknowledgement of application dossier for
cosmetic advertising or organization of cosmetic launch seminar/event: Annex
No. 16-MP.
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18. Adverse
Cosmetic Event Report: Annex No. 18-MP.
Article 52. Transitional clauses
1. From the
effective date of this Circular, all organizations and individuals responsible
for placing cosmetic products in the Vietnamese market shall notify cosmetic
products as prescribed in this Circular.
2. For any
product which was notified from March 10, 2008 (according to the Regulation on
cosmetic management enclosed with the Decision No. 48/2007/QD-BYT dated
December 31, 2007 of the Minister of Health), issued with an cosmetic product
notification number which remains effective and complies with regulations of
this Circular, such product may continue to be manufactured (for domestically manufactured
cosmetics) or imported (for foreign cosmetics) until the expiry of the cosmetic
product notification number.
3. For a
circulated cosmetic product which fails to satisfy requirements for cosmetic
product safety as prescribed in Chapter IV of this Circular, the organization
or individual responsible for placing the product in the market must recall it
and strictly comply with the regulations laid down in this Circular.
4. For a
cosmetic product circulated during the effective period of the license, if it
satisfies requirements for cosmetic product safety as prescribed in Chapter IV
of this Circular, it may continue to be circulated until its expiry.
Article 53. Effect
1. This
Circular comes into force from April 01, 2011.
2. The
Decision No. 48/2007/QD-BYT dated December 31, 2007, Decision No.
22/2008/QD-BYT and Decision No. 3450/QD-BYT of the Ministry of Health are
repealed.
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4. Any
difficulties that arise during the implementation of this Circular should be
reported to the Ministry of Health (Drug Administration of Vietnam, 138A Giang
Vo, Ba Dinh, Hanoi) so as for the Ministry of Health to consider and resolve
them./.
PP. THE
MINISTER
THE DEPUTY MINISTER
Cao Minh Quang