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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.
09/2015/TT-BYT
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Hanoi, May 25,
2015
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CIRCULAR
STIPULATING THE APPROVAL FOR CONTENTS OF ADVERTISEMENTS FOR
SPECIAL PRODUCTS, COMMODITIES AND SERVICES UNDER THE AUTHORITY OF THE MINISTRY
OF HEALTH
Pursuant to the Law on Advertising dated June
21, 2012;
Pursuant to the Law on Food Safety dated June
17, 2010;
Pursuant to the Law on Medical Examination
and Treatment dated November 23, 2009;
Pursuant to the Law on Chemicals dated
November 21, 2007;
Pursuant to the Law on Pharmacy dated June
14, 2005;
Pursuant to the Government’s Decree No.
181/2013/NĐ-CP dated November 14, 2013 on providing specific provisions on
implementation of several articles of the Law on Advertising;
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Pursuant to the Government’s Decree No.
63/2012/NĐ-CP dated August 31, 2012 on defining the functions, tasks, powers
and organizational structure of the Ministry of Health;
After considering the request of the Director
of the Department of Legal Affairs;
The Minister of Health hereby promulgates the
Circular on the approval for contents of advertisements for special products,
commodities and services under the authority of the Ministry of Health.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of
application
This Circular stipulates requirements, authority
to decide, necessary documentation submitted to apply for and procedures for
approval for contents of advertisements for special products, commodities and
services under the authority of the Ministry of Health which include:
1. Pharmaceutical products which are not
prohibited from being advertised as stipulated in Clause 5 Article 7 of the Law
on Advertising.
2. Cosmetic products.
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a) Functional foods
b) Micronutrient-fortified foods
c) Natural mineral water;
d) Bottled drinking water;
dd) Food additives or food processing aids
4. Chemicals, pesticide products, disinfectants
or sanitizers used in household appliance and health care industry.
5. Medical equipment.
6. Baby milk and nutritional products under the
authority of the Ministry of Health which are not subject to the advertising
ban stipulated in Clause 1 Article 7 of the Law on Advertising.
7. Health care services.
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This Circular shall apply to organizations or
individuals engaged in approval for contents of advertisements for special
products, commodities and services under the authority of the Ministry of
Health throughout Vietnam.
Article 3. Examination cost,
fee for issuance and reissuance of the written approval for contents of
advertisements for special products, commodities and services under the authority
of the Ministry of Health
1. The applicant for approval for advertisement
contents shall be liable for the examination cost, fee for issuance or
reissuance of advertisement contents at the competent authority that receives
the application for advertisement contents in accordance with laws.
2. While filing an application for approval for
the content of an advertisement, advertisement examination cost and approval
fee must be paid as follows:
a) The followings shall be considered as one
application for approval for advertisement contents, including:
- An advertisement for a product, commodity or
service that target a particular group of customers;
- An advertisement for a product, commodity or
service that targets a particular group of customers and takes different
advertisement forms such as fliers, banners, books or newspapers, etc.
b) The followings shall not be considered as one
application for approval for advertisement contents, including:
- Different advertisements for a product,
commodity or service that target a particular group of customers. In this case,
each advertisement shall be considered as an application for approval for
advertisement contents;
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c) Advertising of pharmaceutical products:
The followings shall be considered as one
application for approval for pharmaceutical advertisement contents, including:
- Cases governed by regulations laid down in
Point a Clause 2 of this Article;
- An advertisement for a pharmaceutical product
with one content or one dosage form that target a particular group of
customers;
- An advertisement for two or multiple
pharmaceutical products with the same active ingredient, and different
contents, dosage forms or administration which are produced by the same manufacturer
and target a particular group of customers.
d) Advertising of cosmetic products:
a) The followings shall be considered as one
application for approval for cosmetic advertisement contents, including:
- Cases governed by regulations laid down in
Point a Clause 2 of this Article;
- One advertisement for two or multiple products
together with one notification of the cosmetic products with the receiving
number
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- The followings shall be considered as one
application for approval for food or food additive advertisement contents,
including:
+ Cases governed by regulations laid down in
Point a Clause 2 of this Article;
+ An advertisement for two or multiple food or
food additive products which have the same effect and target a particular group
of customers.
- The followings shall be considered as one
application for approval for food or food additive advertisement contents,
including:
+ Cases governed by regulations laid down in
Point b Clause 2 of this Article;
+ An advertisement for two or multiple food or
food additive products which have the same effects and target different groups
of customers. In this case, each product shall be considered as an application
for approval for advertisement contents.
Chapter II
REQUIREMENTS, AUTHORITY
TO DECIDE, NECESSARY DOCUMENTATION SUBMITTED TO APPLY FOR AND PROCEDURES FOR
APPROVAL FOR CONTENTS OF ADVERTISEMENTS FOR SPECIAL PRODUCTS, COMMODITIES AND
SERVICES UNDER THE AUTHORITY OF THE MINISTRY OF HEALTH
Article 4. General
requirements for grant of approval for an advertisement content
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2. Voices, wording and pictures used in an
advertisement must be concise, common and conform to regulations laid down in
Article 18 of the Law on Advertising. The smallest size of the font used in an
advertisement content must be large enough to be read in a normal condition and
is not smaller than the size proportional to the size of Vntime font or the
12-point size of Times New Roman font printed on the A4-size paper.
Article 5. Requirements for
grant of approval for a pharmaceutical advertisement content
Pharmaceutical products must meet requirements
for being advertised as stipulated in Point a Clause 4 Article 20 of the Law on
Advertising, and conform to the regulations laid down in Article 3 of the
Government's Decree No. 181/2013/NĐ-CP on providing specific regulations on
implementation of several articles of the Law on Advertising (hereinafter
referred to as the Decree No. 181/2013/NĐ-CP) as well as the following specific
provisions:
1. Pharmaceutical products permitted to be
advertised in accordance with Clause 1 Article 1 hereof shall include:
a) Pharmaceutical products specified in the list
of over-the-counter medicines and not subject to the competent authority’s
warning of restricted use or permitted use under the doctor’s medical
supervision;
b) With regard to advertising of pharmaceutical
products through audio and video news, such products must contain main active
ingredients in the list of medicinal active ingredients and herbal materials
permitted to be advertised through audio and video news as stipulated in the
Appendix No. 02 enclosed herewith.
2. Pharmaceutical products have been accredited
by numerical codes of free circulation in Vietnam which remain valid and
instructional leaflets which have been approved by the Ministry of Health.
3. All necessary documents must be submitted as
stipulated in Article 14 hereof.
4. The applicant for approval for advertisement
contents is the organization that signs its name on the registration
certificate of free circulation for products, or the Vietnam representative
office of the organization that signs its name on the registration certificate
of free circulation for products, or the organization with its legal standing
authorized in writing by the organization that signs its name on the
registration certificate of free circulation for products.
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a) Be consistent with documents stipulated in
Clause 1 Article 3 of the Decree No. 181/2013/NĐ-CP;
b) Provide sufficient information stipulated in
Clause 2 Article 3 of the Decree No. 181/2013/NĐ-CP and the following
information:
- When advertising pharmaceutical products on
books, newspapers, magazines and flyers, the information such as precautions,
dosage and administration must be included;
- As for advertising of pharmaceutical products
on audio and video news, the contents defined in Clause 3 Article 3 of the
Decree No. 181/2013/NĐ-CP, indications, contraindication or warnings to special
users, must be clear in order for audiences to hear or read in a sufficient and
explicit manner;
- Advertisements aired on online newspapers,
electronic information pages and advertising screens:
+ Sound advertisement contents must include
information pieces which are the same as advertisements aired on audio and
video news;
+ Non-sound advertisement contents must include
information pieces which are the same as advertisements aired on books,
newspapers, magazines and flyers;
If there are many advertising pages/shots, these
pages/shot should be in steady motion, or paused deliberately in order for
viewers to read all information conveyed on that page; pages or shots
displaying product information should be unanimated without any movement in
order for viewers to carefully read such information.
c) Pharmaceutical advertisement contents by
means of outdoor means must include all necessary information stipulated in
Clause 4 Article 3 of the Decree No. 181/2013/NĐ-CP.
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- Indications stipulated in Clause 5 Article 3
of the Decree No. 181/2013/NĐ-CP;
- Indications of curing viral hepatitis and
strange diseases currently emerging.
dd) Information or images banned for use in the
pharmaceutical advertising shall include:
- Information or images stipulated in Clause 6
Article 3 of the Decree No. 181/2013/NĐ-CP;
- Overstatement of pathological conditions or
effects of a pharmaceutical product;
- Images of animals or plants defined in the
list of protected animals or plants;
- Information, images likely to make consumers
believe that consultation with doctors before using the pharmaceutical product
is not important; the pharmaceutical product is absolutely harmless to consumers;
there is none of side effects or contraindications; and the pharmaceutical
product is 100% effective .
Article 6. Requirements for
grant of approval for a cosmetic advertisement content
1. Cosmetic products must conform to
advertisement requirements stipulated in Point b Clause 4 Article 20 of the Law
on Advertising.
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a) Do not use images, costumes, names, mails and
articles of other organizations, healthcare establishments, doctors,
pharmacists or medical staff;
b) Features and effects of a cosmetic product
must accord with its nature, classification as well as those that have been
already made known to the public in accordance with legal regulations.
3. All necessary documents must be submitted as
stipulated in Article 15 hereof.
4. The applicant for approval for advertisement
contents is the organization that signs its name on the product notification,
or the representative office of that organization, or the organization with its
legal standing authorized in writing by that organization.
Article 7. Requirements for
grant of approval for a food, food additive advertisement content
1. Food or food additive products endorsed by
the certificate of declaration of conformity to food safety regulations
(applicable to products that have not been governed by National technical
regulations) or certificate of declaration of conformity issued by the
competent regulatory authorities.
2. Advertisement contents must conform to
regulations laid down in Article 5 of the Decree No. 181/2013/NĐ-CP and the
followings:
a) As for advertisement contents other than
those that have been already announced, legal documents, scientific studies
that support these contents must be submitted while reference sources must be
specified in the mockup or script of an advertisement; as for products with
special use and storage, these must be presented in an advertisement;
b) An advertisement displayed on signboards,
signs, banners, racks, shelves, or in the form of texts running at the bottom
of the screen in a television program, imprinted on other items, or objects in
the air, under the water, or movable objects, shall not be required to contain
all information about how to use the product, effects, storage but shall be
required to be consistent with the contents regulated by declaration of
conformity or declaration of compliance with food safety regulations;
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d) Prohibit using images, costumes, names or
mails of organizations, healthcare establishments, doctors, pharmacists,
medical staff and testimonials of patients to serve the purpose of advertising
food products.
3. All necessary documents must be submitted as
stipulated in Article 16 hereof.
4. Applicants for approval for advertisement
contents are those who sign their names on the Certificate of Declaration of
conformity or Certificate of Declaration of conformity with the food safety
regulations (applicable to products on which the National technical regulations
has not been set yet), or have their legal standing to be authorized in writing
by the legal holder of Certificate of Declaration of conformity and Certificate
of Declaration of conformity with the food safety regulations.
Article 8. Requirements for
approval for contents of advertisements for chemicals, insecticides,
disinfectants or sanitizers used in household appliance and health care
industry.
1. All advertisement requirements stipulated in
Point c Clause 4 Article 20 of the Law on Advertising must be met.
2. Advertisement contents must conform to
regulations laid down in Article 6 of the Decree No. 181/2013/NĐ-CP.
3. All necessary documents must be submitted as
stipulated in Article 17 hereof.
4. The applicant for approval for advertisement
contents is the organization that signs its name on the registration
certificate of free circulation for products, or the organization that has its
legal standing to be authorized in writing by the legal holder of the
registration certificate of free circulation for products.
Article 9. Requirements for
grant of approval for contents of advertisements for medical equipment
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2. Advertisement contents must conform to
regulations laid down in Article 7 of the Decree No. 181/2013/NĐ-CP.
3. All necessary documents must be submitted as
stipulated in Article 18 hereof.
4. The applicant for approval for advertisement
contents is the organization that signs its name on the registration
certificate of free circulation for products in respect of products
manufactured in Vietnam or the import license in respect of imported products,
or the Vietnam representative office of the organization that signs its name on
the import license, or the organization with its legal standing authorized in
writing by the organization that signs its name on the certificate of product
circulation for products manufactured in Vietnam or the import license for
imported products.
Article 10. Requirements
for approval for contents of advertisements for baby milk and nutritional
products
1. All advertisement requirements stipulated in
Point d Clause 4 Article 20 of the Law on Advertising must be met, and these
products must be endorsed by Certificate of Declaration of conformity or
Certificate of Declaration of conformity with the food safety regulations
(applicable to products on which the technical regulations have not been set
yet) issued by regulatory authorities.
2. Advertisement contents must conform to
regulations laid down in Article 8 of the Government’s Decree 181/2013/NĐ-CP
and Clause 2 Article 6 of the Government’s Decree No. 100/2014/NĐ-CP dated
November 6, 2014 on providing regulations on trading and consumption of infant
nutritional products, feeding bottles and artificial nipples.
3. All necessary documents must be submitted as
stipulated in Article 16 hereof.
4. Applicants for approval for advertisement
contents are those who sign their names on the Certificate of Declaration of
conformity or Certificate of Declaration of conformity with the food safety
regulations (applicable to products on which the National technical regulations
has not been set yet), or those who have their legal standing to be authorized
in writing by the legal holder of Certificate of Declaration of conformity and
Certificate of Declaration of conformity with the food safety regulations.
Article 11. Requirements
for approval for contents of advertisements for health care services
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a) The license for medical operations,
applicable to healthcare establishments;
b) The certificate of medical practice,
applicable to those required to achieve the practicing certificate by laws
before being allowed to practise medical services.
2. Advertisement contents must conform to
regulations laid down in Article 9 of the Decree No. 181/2013/NĐ-CP.
3. All necessary documents must be submitted as
stipulated in Article 19 hereof.
4. Applicants for approval for advertisement
contents are those who sign their names on the licence for medical operations,
or those who have the legal standing to be authorized in writing by the legal
holder of the license for medical operations.
Article 12. Authority to
issue the certificate of approval for advertisement contents that fall within
the remit of the Ministry of Health
1. Organizations affiliated to the Ministry of
Health shall have authority to issue the Certificate of approval for
advertisement contents:
a) Drug administration of Vietnam shall issue
the certificate of approval for advertisement contents for pharmaceutical
products as stipulated in Clause 1 Article 1 hereof;
b) Vietnam Food Administration shall issue the
Certificate of approval for advertisement contents for functional food;
micronutrient-fortified food; baby milk and nutritional products as stipulated
in Clause 6 Article 1 hereof;
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d) Traditional Medicine Administration of
Vietnam shall issue the Certificate of approval for advertisement contents for
medical examination and treatment by employing traditional medicinal practices
released by healthcare establishments of which operations are licensed, and the
list of professional practices is approved by the Minister of Health;
dd) Health Environment Management Agency shall
issue the Certificate of approval for contents of advertisements for chemicals,
insecticides, disinfectants or sanitizers used in household appliance and
health care industry;
e) Medical Equipment and Facilities
Administration shall issue the Certificate of approval for advertisement
contents for medical equipment and facilities (acting on behalf of the Minister
of Health to sign).
2. The Department of Health in a
centrally-affiliated city or province shall issue the Certificate of approval
for advertisement contents for:
a) Cosmetic products of the organization that
signs their name on the notification of cosmetic products with their head
office located within the remit of the Department of Health; If cosmetic
products are advertised through conferences, seminars or events, the Department
of Health in a centrally-affiliated city or province which is the proposed
venue for these activities shall issue the Certificate of approval for
advertisement contents;
b) Medical examination or treatment services
provided by healthcare establishments of which operations are licensed and the
list of professional practices are approved by the Director of the Department
of Health.
3. The Food Safety and Hygiene Subdepartment
affiliated to the Department of Health in a centrally-affiliated city or
province shall have authority to:
a) Issue the Certificate of approval for
advertisement contents for mineral water, bottled water, food additives, food
processing aids;
b) Issue the Certificate of approval for
advertisement contents for forms of advertising through conferences, seminars
and events for promotion of food and food additive products as stipulated in
Clause 3 Article 1 hereof which are organized in the areas that fall within
their remit;
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Article 13. General
requirements for application for approval for contents of advertisements for
products, commodities or services under the authority of the Ministry of Health
1. The application shall include 01 set of
documents.
2. Each application shall include the following
documents:
a) Application form for approval for
advertisement contents in accordance with regulations laid down in the Appendix
01 enclosed herewith;
b) The Certificate of Business Registration of
an enterprise or the license for representative office establishment of a
foreign dealer;
c) Contents of applications for approval for
advertisements:
- If these are advertised on audio and video
news, the applicant is required to prepare 01 recording of proposed
advertisement content written in VCDs, CDs or in the form of soft copies
together with 03 copies of proposed advertising scripts in which contents,
proposed advertisement instruments, pictorial (applicable to video news), oral
and music contents, must be clearly described;
- If these are advertised on the advertising
means distinct from audio and video news, the applicant is obliged to prepare
03 copies of mockups of proposed advertisement contents printed in color in
combination with soft copies recording the proposed advertisement contents;
- If these are advertised through conferences,
seminars or events: In addition to materials stipulated in this point, the
applicant is required to submit the followings: the valid sample of
advertisement contents used in the program approved by competent authorities
(applicable to advertisements of which contents have been approved), agenda in
which the presentation title and time (dd/mm/yy), venue (specific address);
presentation contents, materials and handouts; name tags including academic
ranks and professional qualifications of presenters (presenters must hold
qualifications or degrees appropriate to products, commodities and services to
be advertised. Advertising of pharmaceutical products: Presenters must hold
professional qualifications in pharmacy. Advertising of healthcare services:
Presenters must hold professional qualifications in medicine. Advertising of
foods, food additives and food processing aids: Presenters must hold
professional qualifications in medicine and pharmacy or other university degree
or higher degree in relevant disciplines.
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3. Other requirements imposed on applications:
a) If the authorized applicant is filing the
application for approval for advertisement contents, the following documents
must be shown:
- Legal authorization letter;
- The Certificate of business registration or
the license for representative office establishment of a foreign dealer held by
the authorized applicant.
b) Materials used for reference, demonstration
and verification of information provided in the advertisement content:
- English materials must be translated into
Vietnamese, enclosing the original English ones. Translated materials in
Vietnamese must be sealed by the applicant for approval for advertisement
contents;
- Materials in foreign languages other than
English must be translated into Vietnamese, enclosing the original copies of
these materials. Materials translated into Vietnamese must be notarized in
accordance with legal regulations.
c) Materials included in the application must be
high-quality printouts which are arranged to follow procedures stipulated in
articles hereof. Colorful pages are placed in between to separate different
parts, and the cover page and list of materials are required as well;
d) Documents included in the application for
approval for advertisement contents must remain valid, or must be the
authenticated duplicate or sealed duplicate of the applicant for approval for
advertisement contents. All materials attached must be validated by stamp or
edge stamp of the applicant for approval for advertisement contents;
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4. Requirements imposed on applications
submitted to the provider of level-4 online public services:
Applications shall be converted into soft files
(01 copy) and governed under the direction of the provider of level-4 online
public services
Article 14. Application for
approval for a pharmaceutical advertisement content
1. Documents stipulated in Article 13 hereof.
2. User’s instruction leaflets approved by the
Drug Administration of Vietnam – the Ministry of Health.
3. Permit for product free circulation issued by
the Drug administration of Vietnam or the decision on issuance of
pharmaceutical registration numbers at the Drug Administration of Vietnam.
Article 15. Application for
approval for a cosmetic advertisement content
1. Documents stipulated in Article 13 hereof.
2. Notification of cosmetic products issued by
competent authorities.
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Article 16. Application for
approval for advertisement contents for foods, food additives, baby milk and
nutritional products
1. Documents stipulated in Article 13 hereof.
2. The Certificate of Declaration of conformity
or Certificate of Declaration of conformity with the food safety regulations
(applicable to products on which the technical regulations have not been set
yet) issued by regulatory authorities.
3. Description of details about products which
have been verified by competent authorities.
4. Valid and authoritative materials that
demonstrate features, useful effects and particulars of these products. This
will apply if the advertisement content provides information about features,
useful effects and particulars of these products but such information are not
included in the description of details about products verified by competent
authorities.
Article 17. Requirements
for approval for contents of advertisements for chemicals, insecticides,
disinfectants or sanitizers used in household appliance and health care
industry.
1. Documents stipulated in Article 13 hereof.
2. The registration Certificate of free
circulation for chemicals, insecticides, disinfectants or sanitizers.
Article 18. Application for
approval for contents of advertisements for medical equipment
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2. The permit for import of medical equipment or
the registration certificate of free circulation for medical equipment.
Article 19. Application for
approval for contents of advertisements for health care services
1. Documents stipulated in Article 13 hereof.
2. The permit for advertising of healthcare
services granted by the Minister of Health or the Director of the Department of
Health to healthcare establishments, and the professional practices approved by
the Minister of Health or the Director of the Department of Health.
3. The Certificate of healthcare practicing held
by the medical practitioner licensed to advertise their services. This will
apply if the law stipulates that the practice certificate is compulsory.
Article 20. Procedure for
grant of the certificate of approval for advertisement contents
1. The applicant for approval for advertisement
contents shall submit the application to the competent authority as stipulated
in Article 12 hereof (hereinafter referred to as the receiving authority).
2. If the application is not valid, within a
permitted period of 05 working days from receipt of such application based on
the date stamp affixed to incoming documents at the receiving authority, the
receiving authority shall send a request to the applicant for correction or
improvement of this application. The maximum period allowed for the applicant
to correct or improve their application is 90 days from receipt of the written
notification from the receiving authority. After this period, the application
for approval for advertisement contents shall be annulled.
3. Within 10 working days from receipt of all
necessary documents based on the date stamp affixed to incoming documents, the
competent authority shall issue the Certificate of approval for advertisement
content by completing the form recommended in the Appendix 03 enclosed
herewith. In case of refusing to issue the Certificate of approval for
advertisement contents, the competent authority shall respond to the applicant
to clearly state the reasons for such refusal.
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5. As for advertising in the form of seminars,
conferences or events:
a) At least 02 working days prior to
commencement of advertising activities, organizations or individuals that have
products, commodities or services under the authority of the Ministry of Health
and have obtained the Certificate of approval for advertisement contents from
the regulatory agencies affiliated to the Ministry of Health in terms of
advertising carried out in the form of seminars, conferences or events must
send a written notification of the advertising form, time and location along
with the duplicate of the certificate of approval for advertisement contents,
sample advertisements or layouts approved by the Department of Health of the
place where advertising activities take place in order for them to carry out
their inspection and examination whenever necessary;
b) In case there is any change made to the
location, time of seminars, conferences or events in comparison with the
contents specified on the Certificate of approval for advertisement contents,
these organizations or individuals must notify the Department of Health located
at the area where these events are held at least 02 working days prior to
commencement of advertising activities.
6. Procedures for applying for grant of approval
for advertisement contents must be repeated from the first steps under the
following circumstances:
a) The applicant for approval for advertisement
contents that corrects or improves their application upon the written request
for improvement or correction of this application sent by the receiving
authority;
b) The applicant for approval for advertisement
contents that fail to correct or improve their application by the deadline as stipulated
in Clause 2 of this Article.
7. Any organization or individual committing
violations against the law on advertising shall be subjected to the competent
authority’s refusal to continue to receive their application for approval for
advertisement contents until the decision on sanction against such violations
has been granted and the violating organization or individual has managed to
take action according to this decision.
Article 21. Reissuance of
the certificate of approval for advertisement contents
1. The damaged or lost certificate of approval
for advertisement contents shall be reissued under the following circumstances:
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b) Within 05 working days from receipt of the
written request based on the date stamp affixed to incoming documents at the
receiving authority, the competent authority for approval for advertisement
contents shall consider reissuing the certificate of approval for advertisement
contents to the applicant. In case of refusing to reissue the Certificate of
approval for advertisement contents, the competent authority shall respond to
the applicant to clearly state the reasons for such refusal.
2. Reissuance of the certificate of approval for
advertisement contents shall be permitted if the validity period of that
certificate ends as stipulated in Point a Clause 1, Point a Clause 2, Point a
Clause 3, Point a Clause 4 and Point a Clause 5 of Article 23 hereof and the
advertisement contents shall remain unchanged as follows:
a) The organization that signs their name on the
Certificate of approval for advertisement contents, or the authorized
organization in accordance with regulations, shall send their application for
this reissuance to the competent authority that issued the previous
certificate, including the following documents:
- Application form for reissuance of the
certificate of approval for advertisement contents by completing the form
recommended in the Appendix 04 enclosed herewith;
- One of the valid documents relevant to
products, commodities or services for which advertisement contents are
requested to be approved as follows:
+ As for pharmaceutical advertisement: The
certificate of free circulation for products issued by the Drug Administration
of Vietnam and the decision on issuance of the pharmaceutical registration
numbers granted by this Administration;
+ As for cosmetic advertisement: the
notification of cosmetic products issued by competent authorities;
+ As for advertising of food or food additive
products: the Certificate of Declaration of conformity or Certificate of
Declaration of conformity with the food safety regulations (applicable to
products on which the technical regulations have not been set yet) issued by regulatory
authorities; the description of details about products; samples of main labels
approved by competent authorities;
+ As for advertising of chemicals, insecticides,
disinfectants or sanitizers used in household appliance and healthcare
industry: the certificate of free circulation for chemicals, insecticides and
fertilizers;
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- The expired certificate of approval for
advertisement contents along with the approved advertisement sample or layout.
b) Within 05 working days from receipt of the
written request based on the date stamp affixed to incoming documents at the
receiving authority, the competent authority for approval for advertisement
contents shall consider reissuing the certificate of approval for advertisement
contents to the applicant. In case of refusing to reissue the Certificate of
approval for advertisement contents, the competent authority should send a
written notification in which the reasons for such refusal must be clearly
stated.
3. Reissuance of the certificate of approval for
advertisement contents shall be permitted if the validity period of that
certificate still remains but there is a change made to the name, address of
the organization or individual that takes responsibility to launch their
products, commodities or services to the market, and the advertisement contents
remain unchanged as follows:
a) The organization that signs their name on the
Certificate of approval for advertisement contents, or the authorized
organization in accordance with regulations, shall send their application for
this reissuance to the competent authority that issued the previous certificate,
including the following documents:
- Application form for reissuance of the
certificate of approval for advertisement contents by completing the form
recommended in the Appendix 04 enclosed herewith;
- The preexisting certificate of approval for
advertisement contents along with the approved advertisement sample or layout;
- The document of the competent authority
stating the change made to the name, address of the organization or individual
that takes responsibility to launch their products, commodities or services to
the market.
b) Procedure for reissuance of the certificate
of approval for advertisement contents shall be governed under the provisions
of Clause 2, 3, 4, 5 Article 20 hereof.
4. Reissuance of the certificate of approval for
advertisement contents shall be permitted if the validity period of that
certificate ends as stipulated in Article 23 hereof but it does not fall into
the case stipulated in Clause 2 of this Article and the case in which the
advertisement contents are changed or amended but it does not fall into the
case stipulated in Clause 3 of this Article as well:
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5. Application for reissuance of the certificate
of approval for advertisement contents must conform to requirements stipulated
in Clause 3 Article 13 hereof.
Article 22. Method of
numbering the certificate of approval for advertisement contents
1. As for advertisement contents subject to the
certificate of approval for advertisement contents issued by competent agencies
affiliated to the Ministry of Health, the numbering shall adhere to the
principle as follows: the ordinal numbers/issuance year/XNQC- the shortened
name of the issuer. Example: 123/2015/XNQC-ATTP.
2. As for the certificate of approval for
advertisement contents issued by the Department of Health, and Food Safety and
Hygiene Subdepartment, the numbering shall adhere to the principle as follows:
the ordinal numbers/issuance year/XNQC- the shortened name of the issuer and
the shortened name of a centrally-affiliated city and province. Example:
123/2015/XNQC-YTHN or 123/2015/XNQC-ATTPHN.
Article 23. Circumstances
under which the validity of the certificate of approval for advertisement
contents is terminated
1. Circumstances under which the validity of the
certificate of approval for advertisement contents is terminated
a) Pharmaceutical products have the expired
registration numbers;
b) Pharmaceutical products have suspended
registration numbers, or pharmaceutical products are subject to the warning of
restricted use given by regulatory authorities;
c) Change has been made to information about
indications, contraindications or administration dosage.
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a) The receiving numbers of the notification of
cosmetic products has expired;
b) Cosmetic products subject to suspension of
free circulation or revocation or recall of the receiving numbers of the
notification of products;
c) There is any change made to information
affecting the safety and quality of cosmetic products.
3. Circumstances under which the validity of the
certificate of approval for advertisement contents for foods, food additives,
baby milk and nutritional products:
a) The Certificate of Declaration of Conformity
or Certificate of Declaration of conformity with the food safety regulations
has been expired;
b) The enterprise is subject to revocation of
the certificate of conformity with food safety and hygiene requirements;
c) Products or commodities are subject to change
to ingredients or useful effects;
d) Products or commodities are subject to
suspension of free circulation, or are recalled.
4. Circumstances under which the Certificate of
approval for contents of advertisements for chemicals, insecticides,
disinfectants or sanitizers used in household appliance and health care
industry is expired:
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b) Products or commodities are subject to
suspension of free circulation, or are recalled;
c) Products or commodities have been changed or
amended in terms of their ingredients, useful effects or other information
causing impacts on the product safety in comparison with information about
products or commodities specified in the valid registration certificate of free
circulation issued by the Ministry of Health.
5. Circumstances under which the validity of the
certificate of approval for medical equipment is terminated:
a) The import permit or the registration
certificate of free circulation for products or commodities has expired;
b) Products or commodities are subject to
suspension of free circulation, or are recalled.
6. Circumstances under which the validity of the
certificate of approval for advertisement contents for healthcare services is
terminated:
a) Healthcare establishments are subject to
revocation of the permit for operations, their operations are suspended;
b) Healthcare establishments have been deprived
of the ownership of the permit for operations in accordance with legal
regulations on penalties for administrative violations;
c) Healthcare establishments have been reissued
the permit for operations due to change to their scope of professional
operations in relation to healthcare services allowed to be advertised.
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Chapter III
IMPLEMENTARY PROVISIONS
Article 24. Effect
1. This Circular shall come into force from July
16, 2015.
2. From the effective date of this Circular, the
following documents or regulations shall be abolished:
a) Regulations on advertising of pharmaceutical
products enshrined in the Circular No. 13/2009/TT-BYT of the Minister of Health
dated September 1, 2009 on providing guidance on pharmaceutical product
communication and advertising operations;
b) Regulations on pharmaceutical advertising
enshrined in the Circular No. 45/2011/TT-BYT of the Minister of Health dated
December 21, 2011 on amendments to several articles of the Decision No.
1570/2000/QĐ-BYT of the Minister of Health dated May 22, 2000 on application of
the good laboratory practices; the Decision No. 2701/2001/QĐ-BYT of the
Minister of Health dated June 29, 2001 on application of the good storage
practices; the Circular No. 06/2004/TT-BYT of the Ministry of Health dated May
28, 2004 on providing guidance on pharmaceutical contract manufacturing; the
Decision No. 3886/2004/QĐ-BYT of the Ministry of Health dated November 13, 2004
on application of the good manufacturing practices in conformity with the
warning issued by the World Health Organization; the Circular No.
13/2009/TT-BYT of the Ministry of Health dated September 1, 2009 on providing
guidance on pharmaceutical communication and advertising operations; the
Circular No. 22/2009/TT-BYT of the Ministry of Health dated November 24, 2009
on stipulating the pharmaceutical registration; the Circular No. 47/2010/TT-BYT
dated December 29, 2010 on providing guidance on export or import of
pharmaceutical products and packages in physical contact with pharmaceutical
products;
c) The Circular No. 42/2010/TT-BYT of the
Ministry of Health dated December 15, 2010 on promulgating the List of
medicinal active ingredients and herbal ingredients permitted to be advertised
through radio or television programs;
d) Regulations on advertising of cosmetic
products enshrined in the Circular No. 06/2011/TT-BYT of the Minister of Health
dated January 25, 2011 on providing regulations on cosmetic product
administration;
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Article 25. Terms of
reference
1. Where documents used as references in this
Circular have been amended, replaced or abolished, newly-adopted documents
shall be applied.
2. Where documents such as certificates,
licenses, notifications and decisions on issuance of the pharmaceutical
registration number stipulated in this Circular are subject to amendment or
replacement or change of document title stipulated in the competent authority’s
legal documents, newly-adopted documents shall be applied.
Article 26. Transition
provisions
1. Organizations or individuals that have filed
their applications for permission for advertising of special products,
commodities or services under the authority of the Ministry of Health shall
obtain the notice of receipt of applications for permission for advertising
from regulatory authorities before the effective date of this Circular shall be
allowed to continue their advertising activities until the validity of notice
of receipt ends.
2. As for products, commodities or services that
meet requirement for issuance of the certificate of approval for Internet-based
advertisement contents in the form of online public services, competent
authorities shall issue that certificate on the basis of regulations laid down
in this Circular and other relevant laws.
Article 27. Responsibility
for implementation
1. The Heads of competent authorities for
issuance of the certificate of approval for advertisement contents as
prescribed in Article 12 hereof shall be responsible for performing their
assigned tasks according to this Circular, and carrying out examination and
supervision of advertising activities after issuance of that certificate is
completed.
2. The applicants for approval for advertisement
contents shall assume responsibility for legitimacy and accuracy of information
and materials provided in their applications and advertisement contents.
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In the course of implementation, if there is any
difficulty that may arise, agencies, organizations or individuals concerned
should report to the Ministry of Health for to conduct further study and
recommend possible solutions./.
PP. THE
MINISTER
THE DEPUTY MINISTER
Pham Le Tuan
APPENDIX 01
APPLICATION FORM FOR APPROVAL FOR ADVERTISEMENT
CONTENTS
(Issued
together with the Circular No /2015/TT-BYT of the Minister of
Health dated ……….., 2015 on the approval for contents of advertisements for
special products, commodities and services under the authority of the Ministry
of Health)
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.:
/Abbreviated name of the applicant
……(1)……, ……….
20….
APPLICATION
Approval for
advertisement contents
Dear (2)……………………………,
1. Contact information about the applicant: ..................................................................................................................
1.1. The applicant's name:
...............................................................................................
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............................................................................................................................................
Telephone number:
.........................................................Fax:
.........................................
Applies for issuance of approval for
advertisement contents for………………………….:
No.
Description of
product, commodity or service (specifying type, ....(if any))
Numerical code
of the Certificate of free circulation for product, or the Decision on
issuance of the registration number of pharmaceutical product/ Notification
of cosmetic product/ Certificate of Declaration of conformity with the food
safety regulations or Certificate of Declaration of Conformity/ Certificate
of free circulation for chemicals, insecticides, fertilizers used in
household appliance and healthcare industry/ Permit for import of medical
equipment or Certificate of free circulation for medical equipment/ Permit
for healthcare service operations and the Decision on approval for the list
of professional practices
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Means of advertising:
(If verbal, pictorial or printing press are used
for advertising, please specify the specific title of such press; If seminars,
conferences or events are used for advertising, please specify proposed
schedule and venue)
……………………………………………………………………………………………
……………………………………………………………………………………………
Application including the following documents or
materials:
……………………………………………………………………………………………
……………………………………………………………………………………………
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I am looking forward to your consideration and
issuance of approval for the advertisement content./.
The Director
or Legal representative
Signature
(full name, designation and seal)
APPENDIX 02
LIST OF PHARMACEUTICAL ACTIVE INGREDIENTS AND
HERBAL MATERIALS REGISTERED FOR PERMISSION TO BE ADVERTISED ON VERBAL OR
PICTORIAL PRESS
(Issued
together with the Circular No /2015/TT-BYT of the Minister of
Health dated ……….., 2015 on the approval for contents of advertisements for
special products, commodities and services under the authority of the Ministry
of Health)
1. CHEMICALLY SYNTHESIZED PHARMACEUTICALS
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Active
ingredients
Administration,
dosage form, limited content or concentration
Other
specific provisions
1
Acetylcysteine
Oral administration: all forms
2
Acetylleucine
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3
Single acetylsalicylic acid (Aspirin) used
singly or in combination with Vitamin C and/or Citric Acid and/or Sodium
bicarbonate and/or Sodium Salicylate
Oral administration: all forms
Medication for pain or fever relief,
anti-inflammation
4
Alginic acid (Sodium alginate) used singly or
in combination with aluminum or magnesium compounds
Oral administration: all forms
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Single or compound amino acid (including amino
acid combined with Vitamins)
Oral administration: all forms
Medication for amino acid supplement to human
body
6
Aminobenzoic acid (para-aminobenzoic acid)
Oral administration: all forms
7
Pure or compound Benzoic acid
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Oral administration: lozenge
8
Single or compound Boric acid
Topical administration
Eye drop
9
Citric acid combined with sodium or potassium
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10
Cromoglicic acid and cromoglicat of all types
Eye, nasal drop with limited concentration
calculated by Cromoglicic acid ≤ 2%
11
Dimecrotic acid
Oral administration: all forms
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Folic acid used singly or in combination with
iron and/or B-group Vitamins, minerals or Sorbitol
Oral administration: all forms
Medication for anti-anaemia, nutritional
supplement
13
Glycyrrhizic acid (Glycyrrhizinat) combined
with other active ingredients such as Chlorpheniramine Maleate,
Dl-methylephedrine and caffeine, etc.
Oral administration: all forms, including
lozenge
Topical administration
14
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Topical administration
15
Mefenamic acid
Oral administration: all forms
16
Salicylic acid used singly or in combination
with topical pharmaceutical products (in combination with lactic acid;
precipitate phosphorus, etc.)
Topical administration
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17
Albendazol
Oral administration: all forms
Anti-worm medication
18
Dichlorobenzyl alcohol used in combination and
contained in lozenges
Oral administration: lozenges
19
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
20
Alimemazin tartrat (Trimeprazin tartrat)
Oral administration: all forms
21
Allantoin used in combination and contained in
topical or rectal suppository pharmaceuticals (cepae fluid extracts, etc.)
Topical administration
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
22
Allantoin used in combination with Vitamins
and/or Chondroitin
Eye drop
23
Almagate
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Ambroxol used singly or in combination with
cough suppressants, fever or pain relief medicines
Oral administration: all forms with limited
active ingredients as follows:
- Ambroxol clorhydrate with dose unit
measurement ≤ 30mg/unit
- Ambroxol clorhydrate without dose unit
measurement ≤ 0.8%
25
Amylase used singly or in combination with
protease and/or lipase and/or cellulase
Oral administration: all forms
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Amylmetacresol used in combination and
contained in lozenges (like essential oil or Bacitracin, etc.)
Oral administration: lozenges
27
Argyron
Eye drop
Topical administration
28
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
29
Single or compound Aspartat
Oral administration: all forms
30
Attapulgite
Oral administration: all forms
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
31
Azelastin
Eye, nasal drop
32
Silver sulfadiazine
Topical administration
33
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: lozenges
34
Benzalkonium used in combination in topical
medicines (with choline, salicylic acid, Nystatin and Diiodohydroxyquin,
etc.), or in lozenges (with Tyrothricin, Bacitracin and essential oil, etc.)
Topical administration
Lozenges
35
Compound benzocaine
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Rectal suppositories
Oral administration: lozenges
36
Benzoyl peroxide used singly or combined with
Iodine and/or phosphorus
Topical administration all forms with limited
concentration ≤ 10%
37
Benzydamine hydrochloride used singly or in
combination
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: lozenges
38
Benzydamine salicylate used singly or in
combination
Topical administration
39
Compound benzyl benzoate contained in topical
ingredients (combined with essential oil, isopropyl alcohol, etc.)
Topical administration; all forms
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
40
Berberine
Oral administration: all forms
41
Biclotymol used singly or in combination with
Enoxolone and/or Phenylephrine HCl and/or Clorpheniramin maleat and/or
essential oil
Topical administration
Nasal drop
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
42
Bifonazole used singly or combined with Urea
Topical administration
43
Bisacodyl
Oral administration: measured unit dose with
content ≤ 10mg/unit
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Bismuth salts
Oral administration: all forms
45
Boldin
Oral administration: all forms
46
Bromelain used singly or combined with trysin
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
47
Bromhexin HCl used singly or in combination in
expectorants, fever or pain relief medicines
Oral administration: all forms with a
restricted amount of Bromhexin HCl as follows:
- With measured dosage ≤ 8mg/unit
- Without measured dosage ≤ 0.8%
Rectal suppository
48
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
49
Bufexamac used singly or in combination in
topical, rectal suppository medicines (with Titanium dioxide, Bismuth,
Subgallate, Lidocaine, etc.)
Topical administration
Rectal suppositories
50
Butoconazol
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
51
Caffeine (combined with paracetamol)
Oral administration: all forms
52
Calamine used singly or in combination in
topical medicines
Topical administration
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Calcium (including compound forms) used singly or in combination with
Vitamin D (Calcitriol) and/or Vitamins and/or Ipriflavone
Oral administration: all forms
Medication for calcium supplement to human
body
54
Carbinoxamine used singly or in combination in
expectorants, fever or pain relief medicines (with Bromhexine and/or
Paracetamol)
Oral administration
55
Carbocysteine
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
56
Carbomer
Topical administration
Eye drop
57
Catalase used singly or in combination in
topical medicines (with Neomycin)
Topical administration
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
58
Cetirizine dihydrocloride
Oral administration: all forms
59
Cetrimide used in combination in topical
medicines (Lidocaine, zinc, Calamine, Aminacrine, essential oil, etc.)
Topical administration
60
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
Oral administration: lozenges
61
Chitosan (Polyglusam)
Topical administration
62
Choline used singly or in combination with
amino acids, Vitamins in medicines administered orally; in combination with
salicylic acids, Benzalkonium, etc. in topical pharmaceuticals
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
63
Chondroitin used singly or in combination with
Glucosamine and/or fish oil and/or vitamins and/or amino acids
Oral administration: all forms
64
Chondroitin used singly or in combination with
Borneol and/or Vitamins
Eye drop
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
65
Ciclopirox olamine
Topical administration
66
Cinnarizine
Oral administration: all forms
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Cinchocaine used singly or in combination in
topical, rectal suppository medicines (with Hydrocortisone, Neomycin,
Aesculin, etc.)
Topical administration
Rectal suppositories
68
Citrulline
Oral administration: all forms
69
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
70
Chlorophyll
Oral administration: all forms
71
Clorpheniramine maleate used singly or
in combination in expectorants, fever or pain relief medicines
Oral administration: all forms
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
72
Clorpheniramine maleate combined with
Chondroitin and/or Vitamins
Eye drop
73
Clotrimazol
Oral administration: all forms with limited
concentration ≤ 3%
Vaginal suppositories
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
74
Coenzyme Q10 used singly or combined with
Vitamins
Oral administration: all forms
75
Crotamiton
Topical administration
76
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
Vaginal suppositories
Oral administration: lozenges
77
Desloratadine
Oral administration: all forms with limited
content ≤ 5mg/metered-dosage unit
78
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
79
Dexclorpheniramine maleate used singly or in
combination in expectorants, fever or pain relief medicines
Oral administration: all forms
80
Dexibuprofen
Oral administration: all forms with limited
content ≤ 400mg/metered-dosage unit.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
81
Dexpanthenol
Eye drop
Topical administration
82
Diclofenac used singly or combined with Methyl
salicylate; essential oil-based ingredients, etc.
Topical administration
Eye drop (single)
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
83
Dicyclomine
Oral administration: all forms
84
Diethylphtalate (DEP)
Topical administration
85
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
86
Dimethicone (Dimethylpolysiloxane) used singly
or combined with Guaiazulene
Oral administration: all forms
87
Dimethicone compound contained in topical
medicines (with zinc, calamine, cetrimide, etc.)
Topical administration
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
88
Dimethindene
Oral administration: all forms
Topical administration
89
Disodium inosine monophosphate
Eye drop
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Diosmectite (Dioctahedral smectite)
Oral administration: all forms
91
Diosmin combined with Hesperidin and/or
flavonoid-contained herbal extracts
Oral administration: all forms
92
Diphenhydramine hydrochloride or monocitrate
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- With measured dosage ≤ 50mg/unit
- Without measured dosage ≤ 2.5%
93
Domperidone
Oral administration: all forms with a limited
content as follows:
- With measured dosage ≤ 10mg/unit
- Without measured dosage ≤ 0.1%
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Copper sulfate
Topical administration
95
Doxylamine compounds contained in expectorant,
fever, pain relief medicines (with Paracetamol, other active ingredients
specified in the list of non-prescription medicines
Oral administration: all forms
96
Econazole used singly or combined with
Hydrocortisone
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
97
Enoxolone used singly or in combination in
topical medicines or lozenges
Topical administration: skin cream, oral
mucosal cream, mouth rinse
Oral administration: lozenges
98
Eprazinone
Oral administration: all forms
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
99
Esdepallethrin compounds contained in topical
medicines (with Piperonyl, Spregal, essential oil, substances contained in
essential oil)
Topical administration
100
Single or compound Ethanol
Topical administration (sterilization alcohol)
Oral administration: compound form
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Etofenamate
Topical administration
102
Fenticonazole
Topical administration
103
Fexofenadine
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
104
Flurbiprofen
Lozenges
Topical administration
Eye drop
105
Glucosamine used singly or in combination with
Chondroitin and/or Vitamins
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
106
Glucose or Dextrose used singly or in
combination with Sodium or Potassium
Oral administration: all forms
Medication for sugar or electrolyte
supplement.
107
Glycerine used singly or in combination in
topical medicines, eye drops (with Polysorbate 80)
Topical administration
Eye drop
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
108
Glycerol combined with herbal extracts
Rectal suppositories
109
Guaiphenesin used singly or in combination
with active ingredients specified in the list of over-the-counter medicines
with useful effects of cough suppression, fever and pain relief.
Oral administration: all forms
110
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
111
Hexetidine used singly or combined with
Benzydamine, Cetylpyridinium, Choline Salicylate, Methyl salicylate,
essential oil, etc.)
Topical administration: skin application
cream, mouth rinse
112
Hydrocortisone used singly or combined
with Miconazole, Econazole, Tioconazole, Neomycin)
Topical administration: all forms with
Hydrocortisone concentration ≤ 0.5%
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
113
Hydrogen peroxide (hydrogen peroxide) used
singly or combined with sodium lauryl sulfate and/or essential oil
Topical administration
114
Hydrotalcit
Oral administration: all forms
115
...
...
...
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Eye drop
116
Hyoscine (Scopolamine) butylbromid used singly
or in combination with Meclizine hydrochloride
Oral administration: all forms, including
chews.
Limited content ≤ 20mg/ metered-dosage unit
Patches
117
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Eye drop: all forms
118
Ibuprofen
Oral administration: all forms with limited
content ≤ 400mg/metered-dosage unit.
Topical administration
119
Ichthammol
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
120
Iodine combined with Potassium iodide and/or
Benzoic Acid and/or Salicylic Acid
Topical administration: Concentration ≤ 5%
121
Isoconazol
Topical administration
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Isopropyl Methylphenol
Topical administration
123
Zinc oxide, Zinc pyrithione, Zinc Gluconate,
Zinc undecylenate used singly or in combination in topical medicines
Topical administration
124
Zinc sulfate
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Eye drop
125
Ketoconazole used in singly or combined with
Zinc pyrithione and/or Hydrocortisone and/or Trolamine
Topical administration: all forms with
Ketoconazole concentration ≤ 2%
126
Ketoprofen
Topical administration
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
127
Lactitol
Oral administration: all forms
128
Lactoserum atomisate
Topical administration
129
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
130
L-Carnitin used singly or combined with
Vitamins
Oral administration: all forms
131
Levocetirizine
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
132
Single or compound Lidocaine
Topical administration
133
Lindan (Benhexachlor, 666, Gamma-BHC) used
singly or combined with Lidocaine
Topical administration: Lindan concentration ≤
1%
134
...
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Oral administration: all forms with limited
content (calculated by the base form) as follows:
- With measured dosage:
Loratadins ≤ 10mg/unit;
- Without measured dosage:
Loratadine ≤ 0.1%
135
Loxoprofen
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
136
Macrogol
Oral administration: all forms
Rectal suppositories
137
Magaldrate used singly or combined with
Aluminum, Magnesium, Alginic Acid compounds (or Alginate salts).
Oral administration: all forms
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Magnesium, including its salts or compounds
Oral administration: all forms
Medication for magnesium supplement to human
body, gastric acid neutralization or laxativity.
139
Mangiferin
Topical administration
140
Mebendazole
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- With measured dosage ≤ 500mg/unit
- Without measured dosage ≤ 2%
141
Fungi enzyme (cellulase fongique)
Oral administration: all forms
142
Digestive enzymes used singly or in
combination, including vitamins
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
143
Menthol combined with others such as essential
oil complex, Methyl Salycilate, etc.
Oral administration: all forms
Topical administration: all forms
144
Mequinol
Topical administration
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
145
Mequitazine
Oral administration: all forms
Topical administration
146
Mercurocrome (Antiseptic solution)
Topical administration: Package size ≤
30ml
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Methyl salicylate compounds contained in
lozenges, topical medicines (combined with essential oil, etc.)
Topical administration
Patches
Lozenges
148
Metronidazole
Topical administration
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Miconazole
Topical administration
Vaginal cream ≤ 2%
150
Miconazole combined with Hydrocortisone
Topical administration
Vaginal cream with Miconazole content ≤2%;
Hydrocortisone content ≤0.05%
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Minoxidil
Topical administration: all forms with content
≤ ≤5%
152
Mupirocin
Topical administration
153
Myrtol used singly or compound contained in
lozenges
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
154
Naproxen
Oral administration: all metered-dosage forms
with limited content ≤ 275mg/unit
155
Single or compound Sodium benzoate
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
156
Single or compound Sodium bicarbonate
Oral administration: all forms
157
Single or compound Sodium carbonate
Oral administration: all forms
158
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Eye drop
159
Sodium chloride used singly or in combination
with potassium citrate, sodium citrate, etc.
Oral administration: all forms
Topical administration
Eye or nasal drop with concentration 0.9%
160
...
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...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
161
Sodium fluoride compound
Topical administration: teeth cleaning or
mouth rinse
162
Sodium hyaluronate (Hyaluronic acid)
Topical administration
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
163
Sodium Monofluorophosphate
Topical administration, including oromucosal
cleaning
164
Sodium Salicylate compound
Oral administration: compound form contained
in lozenges
Topical administration
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Neomycin sulfate compound contained in
lozenges (zinc; Bacitracin; Amylocaine, etc.), topical medicines
Oral administration: lozenges
Topical administration
166
Dietary elements: Chromium, copper, potassium, magnesium, zinc, etc.
used singly or in combination, including those combined with vitamins
Oral administration: all forms
Medication for mineral supplement to human
body
167
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
Medication for gastric acid neutralization, gastric
ulcer or duodenum mobility.
168
Nomahydrated Natri Sulfid + Saccharomyces
Cerevisiae
Oral administration: all forms
Topical administration
169
Single or compound Nystatin
...
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...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
170
Omeprazole
Oral administration: metered-dosage forms with
content ≤10mg/unit
Medication for gastro esophageal reflux
disease.
171
Ossein hydroxy apatite
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oxeladin
Oral administration: all forms
173
Oxomemazine
Oral administration: all forms
174
Oxymetazoline
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
175
Pancreatin used singly or in combination with
Simethicone and/or digestive enzymes and/or Group-B vitamins and/or
Azintamide
Oral administration: all forms
176
Panthenol
Topical administration
Eye drop
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
177
Single paracetamol
Oral administration: all forms
Rectal suppository
Compound form stipulated in the List
178
Paracetamol combined with active ingredients
specified in this List with useful effects of cough suppression, fever, pain
relief and anti-inflammation
Oral administration: all forms
...
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...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Pentoxyverin
Oral administration: all forms
180
Phenylephrine HCl
Eye or nasal drop with concentration ≤ 1%
181
Phenylephrine HCl used in combination in
topical medicines (such as Petrolatum sperti yellow; Mineral oil light; Shark
liver oil...)
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
182
Phenylephrine HCl used in combination in cough
suppressant, fever and pain relief medicines
Oral administration: all forms
Rectal suppository
183
Phospholipid
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
184
Picloxydine
Eye drop
185
Piroxicam
Topical administration: all forms with content
≤ 1%
186
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
Rectal suppository
187
Polyethylene glycol 400 used singly or in
combination with Propylene glycol
Eye drop
188
Polysacharide
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
189
Polytar used singly or in combination in
topical medicines (such as Zinc Pyrithione, etc.)
Topical administration
190
Povidone Iodine
Topical administration: all forms (including
mouth rinse with concentration ≤ 1%). Eye drop
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Promethazine HCl used singly or in combination
in cough suppressant, fever, pain relief medicines (with Carbocystein;
Paracetamol, etc.)
Oral administration: all forms with limited
content, concentration of Promethazine (calculated by the base form) as
follows:
- With measured dosage ≤ 12.5mg/unit;
- Without measured dosage ≤ 0.1%
Topical administration: concentration ≤
2%
192
Pyrantel
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
193
Rutin used singly or in combination with
Vitamin C and/or herbal extracts
Oral administration: all forms
194
Saccharomyces boulardii
Oral administration: all forms
195
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: all forms
196
Compound iron in the single active ingredient form or iron combined with
vitamin and mineral based medicines
Oral administration: all forms
Medication for iron supplement to human body
197
Organic selenium used in combination in
Vitamin, mineral contained medicines
Oral administration: all forms with limited
content as follows:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
198
Selenium sulfide
Topical administration
199
Silymarin used singly or in combination with
Vitamin C and/or herbal extracts.
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Simethicone used singly or in combination with
Pancreatin and/or Desoxycholic Acid and/or Group-B Vitamins and/or digestive
enzymes
Oral administration: all forms
201
Simethicone combined with aluminum compound,
magnesium and/or Dicyclomine and/or activated carbon
Oral administration: all forms
202
Single or compound Sorbitol
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
203
Sterculia (gum sterculia)
Oral administration: all forms
Rectal suppository
204
Sucralfate
Oral administration: all forms
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
205
Sulbutiamine
Oral administration: all forms
206
Sulfogaiacol used singly or in combination in
fever, pain relief or cough depression medicines
Oral administration: all forms
207
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Topical administration: all forms with content
≤ 1%
208
Single terpin
Oral administration: all forms
209
Tetrahydrozoline
Nasal drop
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210
Activated carbon used singly or in combination
with Simethicone
Oral administration: all forms
211
Essential oil (including Menthol, Pinen, Camphor, Cineol, Fenchone,
Borneol, Anethol, Eucalyptol...)
Oral administration: all forms
Topical administration: skin treatment cream
Mouth wash, oromucosal paste
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
212
Tioconazol used singly or in combination with
Hydrocortisone
Topical administration: all forms with
concentration as follows
- Tioconazol ≤ 1.00%
- Hydrocortisone ≤ 0.05%
213
Tolnaftate
Topical administration
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
214
Triclosan used singly or in combination with
topical medicines
Topical administration
215
Triprolidine used singly or in combination in
cough suppressants, fever or pain relief medicines
Oral administration: all forms
216
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Topical administration
217
Tyrothricin used singly or in combination
(with Benzalkonium, Benzocaine, Formaldehyde, Trolamine, essential oil and
ingredients contained in essential oil)
Oral administration: lozenges
Topical administration: mouthwash solution,
spray and skin cream
218
Urea used singly or in combination with
Vitamin E and/or Bifonazole and/or herbal ingredients which are not specified
in the List of toxic herbal ingredients used for producing pharmaceuticals
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219
Vitamin A and pre-Vitamin A (Betacarotene)
used singly and in combination with vitamins
Oral administration: all forms with limited
content of Vitamin A ≤ 5000 IU/unit
Topical administration
Eye drop
220
Single Vitamin (except for single Vitamin D)
or compounds containing Vitamins, minerals, Amino acids, fatty acids,
taurine, lutein and Zeaxanthin
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Topical administration
Oral compounds containing Vitamin A with
limited content as follows:
Vitamin A ≤ 5000 IU/ metered dosage unit
Medication for Vitamin, mineral and nutrition
supplement
221
Single or compound Group-B vitamin, Vitamin PP
Eye drop
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Bacteria beneficial to digestive health:
Bacillus claussi, Bacillus subtilis, Lactobacillus acidophilus in the
single or compound form, including those combined with vitamins
Oral administration: all forms
223
Methylene blue
Topical administration
224
Xylometazoline used singly or in combination
with Benzalkonium.
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2. ORIENTAL MEDICINES AND HERBAL
MEDICINES
Oriental or herbal medicines are specified in
the List of non-prescription medicines and meet regulations laid down in this
Circular.
APPENDIX 03
TEMPLATE OF CERTIFICATE OF APPROVAL FOR
ADVERTISEMENT CONTENTS
(Issued
together with the Circular No /2015/TT-BYT of the Minister of
Health dated ……….., 2015 on providing guidance on advertising activities under
the authority of the Ministry of Health)
THE MINISTRY
OF HEALTH/THE DEPARTMENT OF HEALTH
………(4)…….
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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Name of
province/city, ………., 20...
CERTIFICATE OF
APPROVAL FOR ADVERTISEMENT CONTENTS
Name of organization, individual:
....................................................................................
Address:
.........................................................................................................
Telephone number: ………………………………..Fax:……………………….
No.
Description of
product, commodity or service (specifying type, ....(if any))
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Means of advertising:
(If verbal, pictorial or printing press are used
for advertising, please specify the specific title of such press; If seminars,
conferences or events are used for advertising, please specify proposed
schedule, venue and presenters)
……………………………………………………………………………………………
……………………………………………………………………………………………
Advertisement contents: In conformity
with approved attached contents of organization/individual in conformity with
applicable regulations.
Organization/ individual shall assume
responsibility to conform to approved advertisement contents.
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Approver
(Signature, full name and stamp)
APPENDIX 04
TEMPLATE OF APPLICATION FOR REISSUANCE OF
CERTIFICATE OF APPROVAL FOR ADVERTISEMENT CONTENTS
(Issued
together with the Circular No /2015/TT-BYT of the Minister of Health
dated ………..,2015 on providing guidance on approval for contents of
advertisements for special products, commodities and services under the
authority of the Ministry of Health)
NAME OF THE
APPLICANT
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.:
/Abbreviated name of the applicant
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPLICATION
Reissuance of
the certificate of approval for advertisement contents
Dear: ..........................(7)...................................
1. The applicant’s
details:………………………………………………………..
1.1. Name of the
applicant:………………………………………………………….
1.2. Office address: (8)…………………………………………………………….
...........................................................................................................................................
Telephone number: ………………………………..Fax:……………………….
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Issue date:.....................................
Issue place:...........................................................
Applies for issuance of the Certificate of
approval for advertisement contents for………..
No.
Description of
product, commodity or service (specifying type, ....(if any))
Numerical code
of the Cerificate of free circulation for product, or the Decision on
issuance of the registration number of pharmaceutical product/ Notification
of cosmetic product/ Certificate of Declaration of conformity with the food safety
regulations or Certificate of Declaration of Conformity/ Certificate of free
circulation for chemicals, insecticides, fertilizers used in household
appliance and healthcare industry/ Permit for import of medical equipment or
Certificate of free circulation for medical equipment/ Permit for healthcare
service operations and the Decision on approval for the list of professional
practices
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Means of advertising:
(If verbal, pictorial or printing press are used
for advertising, please specify the specific title of such press; If seminars,
conferences or events are used for advertising, please specify proposed
schedule and venue)
……………………………………………………………………………………………
……………………………………………………………………………………………
Reasons for application for reissuance of the
certificate of approval for advertisement contents: (9)………………
……………………………………………………………………………………………
Application including the following documents or
materials:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
……………………………………………………………………………………………
I herein undertake all information and
documentation mentioned above are genuine and I am committed to advertising
product, commodity or service under the authority of the Ministry of Health in
accordance with the approved contents.
I am looking forward to your consideration and
issuance of approval for the advertisement content./.
The Director
or Legal representative
Signature
(full name, designation and seal)
(1) Geographical name
(2) The receiving authority: The competent authorities stipulated in
Article 12 hereof.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(4) Name of the receiving authority
(5) Abbreviation of the authority for approval for advertisement contents
(6) Geographical name
(7) Name of the issuer of the certificate of approval for advertisement
contents
(8) Provide the address printed on the certificate of business
registration
(9) Specify reasons as stipulated in Article 21 hereof.