Circular 21/2018/TT-BYT: MARKETING AUTHORIZATION OF TRADITIONAL DRUGS AND HERBAL MATERIALS

MINISTRY OF HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 21/2018/TT-BYT Hanoi, September 12, 2018
CIRCULAR
MARKETING AUTHORIZATION OF TRADITIONAL DRUGS AND HERBAL
MATERIALS
Pursuant to the Law No. 105/2016/QH13 dated April 06, 2016;
Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy;
Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining
functions, tasks, entitlements and organizational structure of the Ministry of Health;
At the request of the Director of the Traditional Medicine Administration of Vietnam,
The Minister of Health hereby promulgates a Circular on marketing authorization of traditional
drugs and herbal materials.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular elaborates:
1. Criteria for determining a traditional drug that is fully exempt from clinical trial, exempt from
certain phases of clinical trial or required to undergo phase 4 of clinical trial or all phases of
clinical trial and requirements for clinical data about drug safety and efficacy as the basis for
issuance of the certificate of traditional drug marketing authorization.
2. Applications and procedures for issuance, extension, adjustment and revocation of certificates
of traditional drug/herbal material marketing authorization.
Article 2. Regulated entities
1. This Circular applies to:
CÔNG TY CỔ PHẦN CÔNG NGHỆ VÀ
ĐẦU TƯ MEDGATE
Hotline: 098.546.1894
Website: medgate.vn

a) Traditional drugs;
b) Prepared traditional medicinal materials concocted in a traditional or modern form;
b) Herbal materials on the list of herbal materials of which marketing authorization is mandatory
promulgated by the Minister of Health as prescribed in Article 93 of the Decree No.54/2017/ND-
CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy.
2. This Circular does not apply to:
a) Traditional drugs mentioned in Point b Clause 1 Article 47, Clause 2 Article 60 and Clauses 1
and 2 Article 70 of the Law on Pharmacy;
b) Herbal materials mentioned in Clause 2 Article 54 of the Law on Pharmacy and semi-finished
herbal materials.
Article 3. Definitions
For the purposes of this Circular, the terms below shall be construed as follows:
1. “semi-finished herbal material” means a product that is derived from herbal materials and has
undergone all processing and manufacturing stages except final packaging.
2. “old remedy” means a traditional drug recorded in Vietnamese and Chinese traditional drug
books before the 19th century, in which the quantity of ingredients, concentration of each
ingredient, concoction methods, effects, indications, administration route, dose, usage and
indications of the remedy.
3. “adjusted old remedy” means a traditional drug whose ingredient and concentration is
increased or reduced to applied to the disease according to traditional drug principles without any
change to the concoction method, administration route, dose, usage and incompatibility between
ingredients in a drug formula.
4. “applicant” means an applicant for issuance, extension or adjustment of a certificate of
traditional drug/herbal material marketing authorization.
5. “traditional drug condition” a patient’s condition that is diagnosed or determined according to
traditional drug principles.
Article 4. Language, presentation and legality of application for issuance, extension or
adjustment of a certificate of traditional drug/herbal material marketing authorization.
1. Language used in the application for issuance, extension or adjustment of a certificate of
traditional drug/herbal material marketing authorization:

a) The application for marketing authorization of domestically manufactured traditional
drug/herbal material must be made in Vietnamese language;
b) The application for marketing authorization of imported traditional drug/herbal material must
be made in Vietnamese or English language. If made in English language, the package insert and
summary of drug characteristics shall be written in Vietnamese language. Documents proving
the safety and efficacy of the traditional drug must be enclosed with their copies written in the
language of the country of origin and issued by a competent authority of the country of origin.
2. The application shall be printed on A4 pages, firmly bound and arranged in the order of its
contents and separated between different parts. Separated parts shall be numbered for easy
reference and each part shall be certified by the applicant or the drug manufacturer on its first
page. The traditional drug/herbal material quality standards, testing method and testing
certificate shall bear the stamp of the manufacturer.
3. There must be 02 (two) sample labels intended for each traditional drug/herbal material.
Regarding imported traditional drug/herbal material, 01 (one) sample label is required in addition
to the 02 aforementioned ones. These labels shall be attached on A4 pages bearing fan stamping
of the applicant or the manufacturer. Upon receipt of the application for extension of the
certificate of marketing authorization, the applicant shall only submit a copy of the approved
sample label in case of no change to the original certificate.
4. The package insert of the traditional drug (excluding prepared traditional medicinal material)
shall comply with regulations on drug and pharmaceutical starting material labeling promulgated
by the Ministry of Health and bear fan stamp of the applicant. The indications and usage must
clearly state traditional drug conditions. In case of extension of the certificate of marketing
authorization, it is not required to return the package insert in case of no change to the original
certificate and extended certificate.
5. Other documents:
a) The application form shall be signed by the head of the applicant or an authorized
representative of the applicant and bear the seal (if any) of the applicant. Signature stamp must
not be used;
b) In the case of authorization, the application shall include an original copy or certified true
copy of the power of attorney issued by the applicant or representative office in Vietnam. To be
specific:
- If the applicant authorized to apply for marketing authorization is not a manufacturer of
traditional drug/herbal material and the foreign manufacturer of traditional drug/herbal material
does not have a representative office in Vietnam, the power of attorney shall be prepared using
the Form No. 09A enclosed with this Circular.

- If the representative office of the applicant for marketing authorization of traditional
drug/herbal material is authorized to sign the marketing application, the power of attorney shall
be prepared using the Form No. 09B enclosed with this Circular.
- If the brand owner that is not an applicant for marketing authorization of traditional drug/herbal
material is authorized to use the name of the traditional drug/herbal material, the power of
attorney shall be prepared using the Form No. 09C enclosed with this Circular.
c) If the applicant is not a drug manufacturer, the certificate of eligibility for pharmacy business
may be a certified true copy or a copy certified by the manufacturer itself;
d) Certificates, protection certificates and contracts for assignment of industrial property rights in
the application for drug marketing authorization (if any) that are granted or certified by industrial
property authorities must be certified true copies or copies bearing stamp of the applicant.
6. Legal documents of a foreign enterprise must comply with the following regulations:
a) Copies or originals of Certificate of pharmaceutical product (abbreviated: CPP), License for
drug manufacturing and trading issued by the foreign competent authority, Certificate of Good
Manufacturing Practice (abbreviated: GMP certificate) and License for establishment of
representative office in Vietnam may be submitted. To be specific:
- If an original is submitted, it must contain the signature, name and title of the signer, issuance
date and stamp of the issuing authority; signature, name and title of the signer and stamp of the
issuing authority. CPP must be consularly legalized in accordance with the law on consular
legalization unless legal documents are issued by competent authorities of the countries that have
signed the mutual legal assistance treaty with Vietnam.
- If a copy is submitted, it must be lawfully certified by a Vietnamese competent authority as
prescribed by Vietnamese law on certification of true copies from originals or copies issued from
master registers. Where necessary, the originals shall be produced for comparison at the request
of the receiving authority;
- The effective period of a license or certificate: The effective period shall be written in the
certificate or license and have to be unexpired when the application is submitted. An official
dispatch on extension of the certificate or license is not accepted.
b) CPP must comply with regulations mentioned in Point a of this Clause and the following
regulations:
- It is issued by a competent pharmacy authority (on the WHO list at http://www.who.int) using
the WHO’s form applicable to the Certification scheme on the quality of pharmaceutical
products moving in international commerce;
- It is certified that the drug is licensed for free sale in the manufacturing country. If the drug is
not licensed for free sale in the manufacturing country or the drug is licensed for free sale but it

is not actually sold in the manufacturing country, the applicant shall must provide the CPP which
certifies that the drug is licensed for sale in one of the countries in which it is actually sold.
c) License for drug manufacturing and trading issued by the foreign competent authority must
comply with regulations mentioned in Point a of this Clause and contain:
- Name and address of the issuing authority;
- Name and address of the drug-trading establishment;
- Scope;
- Effective period, which shall be written in the license and have to be unexpired when the
application is submitted. In case the license does not have an expiration date, the foreign drug-
trading establishment must provide the certificate indicating that it still operates in the pharmacy
field when the application is submitted.
d) WHO GMP certificate, ISO or equivalent certificate must be granted by a competent authority
of the country of origin and contain name and address of the manufacturer.
7. Each traditional drug/herbal material must have a separate marketing application, except in the
cases where the traditional drug (excluding the prepared traditional medicinal material) has the
same formula for a dose unit and concentration but different package contents.
Article 5. Charges for marketing authorization of traditional drug/herbal material
The applicant for marketing authorization of traditional drug/herbal material shall pay charges as
prescribed by the law on charges and fees.
Article 6. Patents and security related to traditional drugs granted marketing authorization
The applicant for traditional drug marketing authorization that wishes to secure data about the
application for marketing authorization of a new traditional drug as prescribed in the Circular
No. 05/2010/TT-BYT dated March 01, 2010 of the Minister of Health shall specify its request
for data security in the application form for issuance, extension or adjustment of the certificate of
marketing authorization and provide legal documents concerning the protection of intellectual
property rights (patent).
Chapter II
CRITERIA FOR DETERMINING A TRADITIONAL DRUG THAT IS FULLY
EXEMPT FROM CLINICAL TRIAL, EXEMPT FROM CERTAIN PHASES OF
CLINICAL TRIAL OR REQUIRED TO UNDERGO PHASE 4 OF CLINICAL TRIAL
OR ALL PHASES OF CLINICAL TRIAL AND REQUIREMENTS FOR CLINICAL
DATA ABOUT DRUG SAFETY AND EFFICACY AS THE BASIS FOR ISSUANCE OF
THE CERTIFICATE OF TRADITIONAL DRUG MARKETING AUTHORIZATION

Article 7. Criteria for determining a traditional drug fully exempt from clinical trial in
Vietnam
1. Prepared traditional medicinal materials.
2. Traditional drug recognized by the Ministry of Health and meeting one of the following
criteria:
a) The traditional drug is an old remedy;
b) The hereditary remedy has been granted a certificate as prescribed by law, has effects and
indications that clearly show the traditional drug condition and has its finished products
commissioned in writing by the Science and Technology Committee or Ethics Committee for
Traditional drug of provincial level or higher upon their sale to ensure the safety and efficacy.
c) The drug that has been used to give treatment to at least 200 (two hundred) patients at a
traditional drug facility of provincial level or higher for at least 10 (ten) years by the time of
submitting the marketing application has stable administration route, dose, manufacturing
process and dosage form, has effects and indications that clearly show the traditional drug
condition and has its safety and efficacy commissioned in writing by the Science and
Technology Committee or Ethics Committee for Traditional drug of provincial level or higher;
d) The traditional drug has been fully exempt from clinical trial, has its dosage form changed but
does not have its ingredients, concentration, indications, effects and administration route
changed, and has its clinical safety and efficacy commissioned in writing by the Science and
Technology Committee or Ethics Committee for Traditional drug of provincial level or higher to
serve disease treatment according to the original remedy;
dd) The adjusted old remedy is used to increase the main effects of the remedy and the added
ingredients do not contain herbal materials on the list of toxic herbal materials promulgated by
the Ministry of Health. Documents and data that prove, analyze or explain the clinical safety and
efficacy of the drug after the adjustment are available;
e) The traditional drug is a product under the scientific project of provincial level or higher, has
its effects and indications that clearly show the traditional drug condition, and has its safety and
efficacy commissioned in writing by the Science and Technology Committee or Ethics
Committee for Traditional drug of provincial level or higher.
3. The traditional drug has been granted a certificate of marketing authorization before the
effective date of the Law on Pharmacy No. 105/2016/QH13 as prescribed in Point b Clause 2
Article 72 of the Law on Pharmacy except in the cases mentioned in Clause 3 Article 8 and
Clause 2 Article 9 of this Circular.
Article 8. Criteria for determining a traditional drug exempt from certain phases of clinical
trial in Vietnam

1. A traditional drug shall be exempt from phase 1 and phase 2 of clinical trial in Vietnam if one
of the following criteria is satisfied:
a) The drug is eligible for full exemption from clinical trial but has its indications adjusted
according to the main effects of the remedy without changing ingredients, dose and dosage form
of the drug;
b) The hereditary remedy that has been granted a certificate in accordance with applicable
regulations is not the one specified in Point b Clause 2 Article 7 of this Circular;
c) The drug that has been used to give treatment to at least 200 (two hundred) patients at a
traditional drug facility of district level or higher for at least 10 (ten) years by the time of
submitting the marketing application has stable administration route, dose, manufacturing
process and dosage form, has its effects and indications that clearly show the traditional drug
condition and has its safety and efficacy commissioned in writing by the Science and
Technology Committee or internal Ethics Committee for Traditional drug at a traditional drug
hospital of provincial level or higher.
2. The traditional drug shall be exempt from phase 1 and phase 2 of clinical trial in Vietnam but
have to undergo the third phase of simplified clinical trial if the following criterion is satisfied:
the drug is eligible for full exemption from clinical trial, has its dosage form changed but does
not have its ingredients, concentration, indications, effects and administration route changed,
except in the cases where the traditional drug is mentioned in Points a and d Clause 2 Article 7 of
this Circular. Biomedical Ethics Committee for traditional drug in the field of traditional drugs
and herbal materials shall consider and decide on the scope and method of simplified clinical
trial in the third phase.
3. A traditional drug that has been granted the certificate of marketing authorization before the
effective date of the Law on Pharmacy No.105/2016/QH13 shall be exempt from phase 1 and
phase 2 of clinical trial at the request of the Advisory Council in one of the following cases:
a) The ingredients of the drug fail to comply with Clause 2 Article 7 of this Circular and
contraindications and/or adverse effects other than those specified in the package insert of the
drug granted the certificate of marketing authorization are found;
b) There are insufficient clinical data about the safety and efficacy of the drug used for treatment
of hepatitis, cancer and some other disease at the request of the Advisory Council.
Article 9. Criteria for determining a traditional drug required to undergo phase 4 of
clinical trial in Vietnam
A traditional drug that has been granted a certificate of marketing authorization is required to
undergo phase 4 of clinical trial in Vietnam if one of the following criteria is satisfied:
1. Additional information is provided to serve the assessment of safety and efficacy of the drug
at the request of a pharmacy authority.

2. The traditional drug that has been granted the certificate of marketing authorization before the
effective date of the Law on Pharmacy No.105/2016/QH13 is required to undergo phase 3 of
clinical trial at the request of the Advisory Council if its ingredients fail to comply with Clause 2
Article 7 of this Article, and contraindications and adverse effects other than those specified in
the package insert of the drug granted the certificate of marketing authorization are not found.
3. The traditional drugs mentioned in Article 8 of this Circular are yet to undergo phase 4 of
clinical trial in Vietnam.
Article 10. Criteria for determining a traditional drug required to undergo all phases of
clinical trial
The traditional drug that is not mentioned in the cases specified in Articles 7, 8 and 9 of this
Circular is required to undergo all phases of clinical trial in Vietnam.
Article 11. Documents proving a traditional drug satisfies criteria for exemption from
clinical trial or certain phases of clinical trial
1. Regarding the old remedy specified in Point a Clause 2 Article 7 of this Article, the documents
proving its origin are specified in Clause 2 Article 3 of this Circular.
2. Regarding the hereditary remedy mentioned in Point b Clause 2 Article 7 or Point b Clause 1
Article 8 of this Circular, the following documents are required:
a) A copy the certificate of hereditary remedy, which is certified or bears the seal of the
manufacturer. In case the copy bearing the seal of the manufacturer is submitted, an original or
certified true copy is required for comparison.
b) A certified true copy of the commissioning record given by the Science and Technology
Committee or Ethics Committee for Traditional drug of provincial level or higher (if any).
3. Regarding the drug used for treatment at health facilities specified in Point c Clause 2 Article
7 or Point c Clause 1 Article 8 of this Circular, the following documents are required:
a) Documents about drug formula; ingredient concoction method; dosage form; usage,
administration route; dose; indications and contraindications;
b) Documents proving that the drug has been used to give treatment to at least 200 (two hundred)
patients for at least 10 (ten) years and has stable administration route, dose, manufacturing
process and dosage form.
c) A certified true copy of the safety and efficacy commissioning record given by the Science
and Technology Committee or Ethics Committee for Traditional drug of provincial level or
higher, regarding the drug mentioned in Point p Clause 2 of Article 7;

d) A certified true copy of the safety and efficacy commissioning record given by the Science
and Technology Committee or internal Ethics Committee for Traditional drug at a traditional
drug hospital of provincial level or higher, regarding the drug mentioned in Point c Clause 1 of
Article 8.
4. Regarding the traditional drug that is fully exempt from clinical trial in Vietnam and has its
dosage form changed, the following documents are required:
a) Documents about drug formula; ingredient concoction method; new dosage form;
b) A package insert that is made in accordance with regulations on drug and pharmaceutical
starting material labeling promulgated by the Ministry of Health and bear fan stamp of the
applicant;
c) Manufacturing process after changing the dosage form;
d) A certified true copy of the safety and efficacy commissioning record given by the Science
and Technology Committee for Traditional drug of ministerial level or higher.
5. Regarding the adjusted old remedy mentioned in Point dd Clause 2 Article 7 of this Circular,
the following documents are required:
a) Documents proving origin of the old remedy as specified in Clause 2 Article 3 of this Circular;
b) Documents about drug formula; adjustment principles; ingredient concoction method; drug
form; usage, administration route; dose; indications and contraindications;
c) Documents and data proving the clinical safety and efficacy of the drug after the adjustment.
Article 12. Cases in which a traditional drug whose safety and efficacy still has to be
monitored after the certificate of marketing authorization is granted
1. The traditional drugs whose marketing authorization is applied for and safety and efficacy still
has to be monitored include:
a) The traditional drugs that contain toxic herbal materials on the list of toxic herbal materials
derived from minerals in the Appendix III and toxic herbal materials not starred (*) on the list of
toxic herbal materials derived from plants and animals in the Appendix I and Appendix II
enclosed with the Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Ministry of
Health on the List of toxic herbal materials;
b) The traditional drugs that do not have sufficient clinical data about drug safety and the
traditional drugs that are exempt from certain phases of clinical trial as prescribed in Article 8 of
this Circular.

2. The traditional drugs whose marketing authorization is applied for still has to have its safety
and efficacy monitored if there is not sufficient clinical data about the safety and efficacy in
accordance with regulations on clinical trial.
3. The certificate of marketing authorization of the traditional drugs mentioned in Clauses 1 and
2 of this Article is valid for 03 years.
Article 13. Requirements for reports on monitoring and assessment of safety and efficiency
during sale of traditional drugs
Traditional drugs still has to have its safety and efficacy monitored as prescribed in Article 12 of
this Article every 06 months and upon submission of the application for extension. To be
specific:
1. The applicant shall send a notification of drug safety and efficacy using the Form No. 8A in
the Appendix I hereof, and retain documents concerning the drug safety and efficacy.
2. The health facility that uses the drug shall send a report on the use of drug using the Form No.
8B in the Appendix I hereof, and retain documents concerning the use of drug to serve the
inspection and assessment of the drug safety and efficacy.
Article 14. Requirements for clinical data about drug safety and efficacy of traditional
drugs in marketing application
1. Clinical studies and data in the clinical documents and technical documents proving the drug
safety and efficacy shall comply with the regulation on Good Clinical Practice promulgated by
the Ministry of Health.
2. Data derived from clinical trial studies may be used to analyze and explain possible effects of
epidemiology, pathology or living conditions in Vietnam on the drug safety and efficacy.
Chapter III
APPLICATIONS AND PROCEDURES FOR ISSUANCE, EXTENSION AND
ADJUSTMENT OF CERTIFICATES OF TRADITIONAL DRUG MARKETING
AUTHORIZATION
SECTION I. APPLICATIONS FOR ISSUANCE, EXTENSION AND ADJUSTMENT OF
CERTIFICATES OF TRADITIONAL DRUG MARKETING AUTHORIZATION
Article 15. Application for issuance of a certificate of traditional drug marketing
authorization
The application for issuance of a certificate of traditional drug marketing authorization shall be
prepared as prescribed in Clause 2 Article 56 of the Law on Pharmacy and include:

1. Administrative documents specified in Article 16 of this Circular.
2. Technical documents specified in Article 17 of this Circular.
3. A sample label of the traditional drug sold at the home country or reference country (for
imported traditional drugs).
Article 16. Administrative documents
Administrative documents include:
1. An application form (Form No. 03A or No. 03B in the Appendix I hereof).
2. Legal documents if the applicant is a manufacturer:
a) A copy of the certificate for eligibility for pharmacy business containing the scope of
traditional drug trading and manufacturing (for the domestic manufacturer);
b) A CPP granted to the imported traditional drug, for the foreign manufacturer, except for
prepared traditional medicinal material. If the CPP does not specify the manufacturer satisfy
GMP standards, a GMP of the foreign manufacturer is required. If multiple manufacturers
engage in the drug manufacturing process, the certificate of GMP of these manufacturers is
required.
3. Legal documents if the applicant is not a manufacturer:
a) Legal documents mentioned in Points a and b Clause 2 of this Article;
b) Legal documents of the applicant:
- A copy of the certificate for eligibility for pharmacy business, for the domestic manufacturer
that has one of the following scopes of business: manufacturing, wholesale, import or export of
traditional drugs;
- The license for establishment of representative office in Vietnam and license for drug
manufacturing and trading issued by the foreign competent authority, for the manufacturer that
has a representative office in Vietnam.
4. A power of attorney made as prescribed in Clause 5 Article 4 of this Circular if the applicant is
authorized.
5. A summary of the traditional drug (Form No. 06A or No. 06B in the Appendix I hereof);
6. A sample label of the traditional drug. Contents of the label shall comply with regulations on
labeling of drugs and pharmaceutical starting materials and package inserts.

7. A package insert made in accordance with regulations of the Ministry of Health on labeling of
drugs and pharmaceutical starting materials and package inserts.
8. Documents about data security specified in Article 6 of this Circular (if any).
9. Other documents (if any).
Article 17. Technical documents
1. Documents about the manufacturing process shall satisfy the following requirements:
a) Documents about the pharmaceutical starting materials: specify the process of manufacturing
of pharmaceutical starting materials in a sufficient and detailed manner (it is not required to
describe the process of manufacturing of excipients and materials stated in the pharmacopoeia,
and materials manufactured by another manufacturer);
b) Documents about finished product must contain:
- A formula for the smallest pack: name of the material, including main ingredients, ancillary
materials and excipients; applied standard; amount of herbal materials if the material is
manufactured from herbal materials that are yet to be standardized in terms of the amount of
active ingredients;
- A formula for a batch: name of the material, including main ingredients and excipients; mass or
volume of each material;
- A diagram of manufacturing process, including all stages in the manufacturing process;
- A description of manufacturing process: sufficiently and specifically describe every stage in the
manufacturing process;
- A list of equipment or tools used in the manufacturing process: name of the equipment, their
specifications, purposes, condition, marketing authorization or declaration number (if any);
- Documents about control of manufacturing process: sufficiently and specifically describe
criteria for the inspection and control of the manufacturing process.
2. Documents about quality standards and testing methods shall satisfy the following
requirements:
a) Regarding the material in the stated in the pharmacopoeia, specify name of the pharmacopoeia
and publishing year. Regarding the material not stated in the pharmacopoeia, specify testing
criteria and methods

b) Standards applied to the finished product: sufficiently and specifically describe criteria and
methods for finished product testing;
c) Packaging standards: sufficiently and specifically describe testing criteria and methods;
d) A drug testing report shall satisfy the following requirements:
- The traditional drug manufacturer that has a drug testing laboratory satisfying GLP
requirements prescribed by the Ministry of Health shall appraise testing standards and methods
itself, and submit its testing report;
- The traditional drug manufacturer that has not yet had a drug testing laboratory satisfying GLP
itself, and submit testing reports of state-owned drug-testing facilities or drug-testing service
providers that have been issued with the certificate of eligibility for pharmacy business.
dd) Requirements for stability study:
Each traditional drug manufacturer shall study and prepare documents proving the stability,
including:
- Draft of stability study;
- Stability study data;
- Conclusion on stability study.
3. Documents proving a drug satisfies requirements for safety and efficacy include:
a) Regarding the traditional drug:
- Clinical and pre-clinical study reports commissioned and approved by the competent authority,
enclosed with a certified true copy of the written approval for study result given by the
competent authority in the cases mentioned in Articles 7, 8, 9 and 10 of this Circular;
- Reports on toxicity of the traditional drug that contains toxic herbal materials on the list of
toxic herbal materials derived from minerals in the Appendix III and toxic herbal materials not
starred (*) on the list of toxic herbal materials derived from plants and animals in the Appendix I
and Appendix II enclosed with the Circular No. 42/2017/TT-BYT dated November 13, 2017 of
the Ministry of Health on the List of toxic herbal materials.
b) Regarding the prepared traditional medicinal material: Reports on toxicity of the traditional
drug that contains toxic herbal materials on the list of toxic herbal materials derived from
minerals in the Appendix III and toxic herbal materials not starred (*) on the list of toxic herbal
materials derived from plants and animals in the Appendix I and Appendix II enclosed with the
Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Ministry of Health on the List of

toxic herbal materials promulgated together with the result of analysis of toxicity of the
traditional drug carried out a competent authority.
4. Documents proving that the traditional drug fails to satisfy criteria for exemption from clinical
trial or certain phases of clinical trial are prescribed in Article 11 of this Circular.
Article 18. Application for extension of the certificate of traditional drug marketing
authorization
An application for extension of the certificate of traditional drug marketing authorization
includes:
2. Documents specified in Clauses 2 and 3 Article 16 of this Circular and documents specified in
Clauses 6 and 7 Article 16 of this Circular if the traditional drug has its administrative documents
changed on the extension date.
3. A report on sale of the traditional drug (Form No. 10 in the Appendix I hereof).
4. A report on safety and efficacy of the drug if its safety and efficacy still has to be monitored
(Form No. 08 in the Appendix I hereof).
5. A copy of the issued certificate of drug marketing authorization in Vietnam.
Article 19. Application for adjustment of the certificate of traditional drug marketing
authorization
An application for adjustment of the certificate of traditional drug marketing authorization
includes:
2. Technical documents about the adjustments: relevant documents specified in the Appendix II
hereof.
3. A copy of the effective certificate of drug marketing authorization in Vietnam.
SECTION II. PROCEDURES FOR ISSUANCE, EXTENSION AND ADJUSTMENT OF
CERTIFICATES OF TRADITIONAL DRUG MARKETING AUTHORIZATION
Article 20. Procedures for issuance of the certificate of traditional drug marketing
authorization
1. The applicant for issuance of the certificate of traditional drug marketing authorization (the
applicant) shall submit an application for issuance of the certificate of traditional drug marketing

authorization (the marketing application) prepared as prescribed in Articles 15, 16 and 17 of this
Circular to the Traditional Medicine Administration of Vietnam - the Ministry of Health (the
receiving authority), whether directly, by post or through the online public service system of the
Ministry of Health.
2. Upon receipt of the satisfactory application, the receiving authority shall give the applicant the
Form No. 02 enclosed herewith. If the application is unsatisfactory, the receiving authority shall
request the applicant in writing or request the applicant (if the application is submitted directly)
to complete it as prescribed.
3. Regarding the traditional drug that is fully exempt from clinical trial, within 06 months from
the receipt of the satisfactory application, the receiving authority shall:
a) assess the application;
b) submit the satisfactory application to the Advisory Council;
c) issue the certificate of traditional drug marketing authorization at the request of the Advisory
Council.
4. Regarding the traditional drug that is required to undergo clinical trial, within 12 months from
the receipt of the satisfactory application, the receiving authority shall follow the procedures
specified in Points a, b and c Clause 3 of this Article.
5. If the application is unsatisfactory as prescribed in Articles 15, 16 and 17 of this Circular,
during the period of consideration of the application, the receiving authority shall promptly
instruct the applicant in writing to complete the application until it is satisfactory. The
application shall be completed within 60 days from the date on which the applicant is instructed
in writing. The length of time of the completion of the application shall not add to the time limit
for considering the application. After the aforementioned deadline, the application will be
rejected and the applicant has to reapply for marketing authorization.
6. If the application is rejected as prescribed in Clauses 3 and 4 of this Article, the receiving
authority shall respond and provide explanation in writing.
Article 21. Procedures for extension of the certificate of traditional drug marketing
authorization
1. At least 03 months before the expiration date of the certificate of marketing authorization, the
applicant shall submit an application for extension of the certificate of traditional drug marketing
authorization (the extension application) prepared as prescribed in Article 18 of this Circular to
the Traditional Medicine Administration of Vietnam - the Ministry of Health (the receiving
authority), whether directly, by post or through the online public service system of the Ministry
of Health. The applicant that fails to submit the extension application by the aforementioned
deadline shall follow the procedures for issuance of the marketing authorization certificate as
prescribed in Article 20 of this Circular.

3. Within 01 month from the receipt of the satisfactory application, the receiving authority shall
consider approving the list of traditional drugs to be covered by the extended certificate of
marketing authorization.
4. If the application is unsatisfactory as prescribed in Article 18 of this Circular, during the
period of consideration of the application, the receiving authority shall promptly instruct the
application in writing to complete the application until it is satisfactory. The application shall be
completed within 30 days from the date on which the applicant is instructed in writing. The
length of time of the completion of the application shall not add to the time limit for considering
the application. After the aforementioned deadline, the application will be rejected and the
applicant has to reapply for extension.
5. If the application is rejected, the receiving authority shall respond and provide explanation in
writing.
Article 22. Application for adjustment of the certificate of traditional drug marketing
authorization
1. The applicant for adjustment of the certificate of traditional drug marketing authorization (the
applicant) shall submit an application for adjustment of the certificate of traditional drug
marketing authorization (the adjustment application) prepared as prescribed in Article 19 of this
Ministry of Health.
3. If any adjustments in the Appendix II.1 enclosed herewith are made to the application for
traditional drug marketing authorization, the applicant shall make such adjustments after the date
on which the receiving authority gives the applicant the form.
traditional drug marketing authorization, within 01 month from the receipt of the satisfactory
application, the receiving authority shall give a written consent to the adjustments to the
certificate of traditional drug marketing authorization.

applicant has to reapply for adjustment.
writing.
Article 23. Priority cases in which the time limit for issuing the certificate of traditional
drug marketing authorization is likely to be reduced
1. The time limit for issuing the certificate of traditional drug marketing authorization specified
in Article 20 of this Circular is likely to be reduced on the basis of the request made by the
applicant in the application form (Form No. 03A or No. 03B in the Appendix I hereof) if:
a) The drug serves purposes related to national defense and security, prevention and elimination
of epidemics, disaster recovery, or need for special treatment;
b) The drug is domestically manufactured on new lines satisfying GMP standards within 12
months from the date in which the GMP certificate is issued.
c) The drug is derived from domestic herbal materials satisfying GACP requirements.
2. Documents and procedures intended for the priority cases shall comply with Article 20 of this
Circular.
Chapter IV
APPLICATIONS AND PROCEDURES FOR ISSUANCE, EXTENSION AND
ADJUSTMENT OF CERTIFICATES OF HERBAL MATERIAL MARKETING
AUTHORIZATION
SECTION I. APPLICATIONS FOR ISSUANCE, EXTENSION AND ADJUSTMENT OF
CERTIFICATES OF HERBAL MATERIAL MARKETING AUTHORIZATION
Article 24. Application for issuance of certificate of herbal material marketing
authorization
The application for issuance of the certificate of herbal material marketing authorization shall
prepared as prescribed in Clause 2 Article 56 of the Law on Pharmacy. It consists of:
1. Administrative documents specified in Article 25 of this Circular.
2. Technical documents specified in Article 26 of this Circular.

3. A sample label of the herbal material sold at the home country or reference country (for
imported herbal materials).
Article 25. Administrative documents
1. An application form (Form No. 03C in the Appendix I hereof).
2. Legal documents if the applicant is a manufacturer:
a) A copy of the certificate for eligibility for pharmacy business containing the scope of domestic
herbal material/prepared traditional medicinal material trading and manufacturing;
b) A copy of the enterprise marketing authorization certificate of the domestic herb farming
establishment;
c) The license for establishment of representative office in Vietnam and License for herbal
material/prepared herbal material manufacturing and trading issued by a competent foreign
authority to the herbal material/prepared herbal material manufacturer that has a representative
office in Vietnam.
3. Legal documents if the applicant is not a manufacturer:
a) Herbal material manufacturer’s legal documents specified in Clause 2 of this Article;
b) Legal documents of the applicant;
- A copy of the certificate for eligibility for pharmacy business, for the domestic manufacturer
that has one of the following scopes of business: manufacturing, wholesale, import or export of
herbal materials or prepared traditional medicinal materials;
- The license for establishment of representative office in Vietnam and License for herbal
material/prepared herbal material manufacturing and trading issued by a competent foreign
authority to the applicant that has a representative office in Vietnam.
4. A power of attorney made as prescribed in Clause 5 Article 4 of this Circular if the applicant is
authorized.
5. A summary of the herbal material (Form No. 06C in the Appendix I hereof).
6. A sample label of the herbal material. Contents of the label shall comply with regulations on
labeling of drugs and pharmaceutical starting materials and package inserts.
7. A package insert made in accordance with regulations of the Ministry of Health on labeling of
drugs and pharmaceutical starting materials and package inserts.

8. Other documents (if any).
Article 26. Technical documents
Technical documents include:
1. Documents about the preparing process shall satisfy the following requirements:
a) A formula for the smallest pack: name of the material; applied standard;
b) A formula for a batch: name of the material; mass or volume of each material;
c) A diagram of preparing process, including all stages in the preparing process;
d) A description of preparing process: sufficiently and specifically describe every stage in the
preparing process;
dd) A list of equipment or tools used in preparing process: name of the equipment, their
specifications and purposes; marketing authorization or declaration number (if any);
e) Documents about control of the preparing process: sufficiently and specifically describe
testing and control criteria in manufacturing process.
2. Documents about quality standards and testing methods shall satisfy the following
requirements:
a) Standards applied to herbal materials: sufficiently and specifically describe criteria and
methods for herbal material testing;
b) Packaging standards: sufficiently and specifically describe testing criteria and methods;
c) A herbal material testing report shall satisfy the following requirements:
- The herbal material manufacturer that has a herbal material testing laboratory satisfying GLP
itself, and include its testing report in the marketing application;
- The herbal material manufacturer that has not yet had a drug testing laboratory satisfying GLP
itself, and include the testing reports of state-owned drug-testing facilities or drug-testing service
providers that have been issued with the certificate of eligibility for pharmacy business in the
marketing application.
Article 27. Application for extension of the certificate of herbal material marketing
authorization

An application for extension of the certificate of herbal material marketing authorization
includes:
2. Documents specified in Clauses 2 and 3 Article 25 of this Circular and documents specified in
Clauses 6 and 7 Article 25 of this Circular if the herbal material has its administrative documents
changed on the extension date.
3. A report on sale of the herbal material (Form No. 10 in the Appendix I hereof).
4. A report on safety and efficacy of the herbal material on the list of toxic herbal materials
promulgated by the Minister of Health (Form No. 08 in the Appendix I hereof).
5. A copy of the issued certificate of herbal material marketing authorization in Vietnam.
Article 28. Application for adjustment of the certificate of herbal material marketing
authorization
An application for adjustment of the certificate of herbal material marketing authorization
includes:
2. Relevant documents about the adjustments specified in the Appendix II hereof.
3. A copy of the effective certificate of herbal material marketing authorization in Vietnam.
SECTION II. PROCEDURES FOR ISSUANCE, EXTENSION AND ADJUSTMENT OF
CERTIFICATES OF HERBAL MATERIAL MARKETING AUTHORIZATION
Article 29. Procedures for issuance of the certificate of herbal material marketing
authorization
1. The applicant for issuance of the certificate of herbal material marketing authorization (the
applicant) shall submit an application for issuance of the certificate of herbal material marketing
authorization (the marketing application) prepared as prescribed in Articles 24, 25 and 26 of this
Ministry of Health.

3. Within 06 months from the receipt of the satisfactory application, the receiving authority shall:
a) assess the application;
b) submit the satisfactory application to the Advisory Council;
c) issue the certificate of herbal material marketing authorization at the request of the Advisory
Council.
4. If the application is unsatisfactory as prescribed in Articles 24, 25 and 26 of this Circular,
during the period of consideration of the application, the receiving authority shall promptly
instruct the application in writing to complete the application until it is satisfactory. The
application shall be completed within 60 days from the date on which the applicant is instructed
in writing. The length of time of the completion of the application shall not add to the time limit
for considering the application. After the aforementioned deadline, the application will be
rejected and the applicant has to reapply for marketing authorization.
5. If the application is rejected as prescribed in Clause 3 of this Article, the receiving authority
shall respond and provide explanation in writing.
Article 30. Procedures for extension of the certificate of herbal material marketing
authorization
1. At least 03 months before the expiration date of the certificate of marketing authorization, the
applicant shall submit an application for extension of the certificate of herbal material marketing
authorization (the extension application) prepared as prescribed in Article 27 of this Circular to
the Traditional Medicine Administration of Vietnam - the Ministry of Health (the receiving
authority), whether directly, by post or through the online public service system. The applicant
that fails to submit the extension application by the aforementioned deadline shall follow the
procedures for issuance of the marketing authorization certificate as prescribed in Article 30 of
this Circular.
request the applicant in writing or request the applicant to complete it as prescribed.
3. Within 03 months from the receipt of the satisfactory application, the receiving authority shall
consider approving the list of herbal materials that are covered by the extended certificate of

applicant has to reapply for extension.
writing.
Article 31. Procedures for adjustment of the certificate of herbal material marketing
authorization
1. The applicant for adjustment of the certificate of traditional drug marketing authorization (the
applicant) shall submit an application for adjustment of the certificate of herbal material
marketing authorization (the adjustment application) prepared as prescribed in Article 28 of this
Ministry of Health.
request the applicant in writing or request the applicant to complete it as prescribed.
herbal material marketing authorization, the applicant shall make such adjustments after the date
on which the receiving authority gives the applicant the form.
herbal material marketing authorization, within 30 month from the receipt of the satisfactory
application, the receiving authority shall give a written consent to the adjustments to the
certificate of herbal material marketing authorization.
applicant has to reapply for adjustment.
writing.
Article 32. Priority cases in which the time limit for issuing the certificate of herbal
material marketing authorization is likely to be reduced
1. The time limit for issuing the certificate of herbal material marketing authorization specified
in Article 29 of this Circular is likely to be reduced on the basis of the request made by the
applicant in the application form (Form No. 03C in the Appendix I hereof) if:

a) The herbal material is domestically collected in accordance with GACP requirements.
b) The herbal material has just been acclimatized to Vietnam so that it can be cultivated on the
basis of scientific researches aimed at proving its effect and quality within 12 months from the
date on which the scientific research result is obtained.
2. Documents and procedures intended for the priority cases shall comply with Article 29 of this
Circular.
Chapter V
REVOCATION OF CERTIFICATES OF TRADITIONAL DRUG/HERBAL MATERIAL
MARKETING AUTHORIZATION
Article 33. Documents about revocation of certificates of traditional drug/herbal material
marketing authorization
Documents about revocation of certificates of traditional drug/herbal material marketing
authorization include:
1. A copy of the decision on the recall of traditional drug/herbal material in the cases where the
traditional drug/herbal material is recalled as prescribed in Points a and b Clause 1 Article 58 of
the Law on Pharmacy.
2. A copy of the decision on the revocation of the certificate of pharmaceutical product that is
revoked by a foreign competent authority in the cases where the traditional drug/herbal material
is recalled as prescribed in Point c Clause 1 Article 58 of the Law on Pharmacy.
3. A certified true copy of the record of administrative violation against regulations on traditional
drugs/herbal materials in the cases where the traditional drug/herbal material is recalled as
prescribed in Points d and dd Clause 1 Article 58 of the Law on Pharmacy.
4. Originals of documents proving that the herbal material or traditional drug containing the
herbal material that is not recommended by WHO or a Vietnamese competent authority or its
country of origin in terms of safety and efficacy in the cases where the traditional drug/herbal
material is recalled as prescribed in Point e Clause 1 Article 58 of the Law on Pharmacy.
5. An application form for revocation of the certificate of traditional drug/herbal material
marketing authorization made by the manufacturer or the applicant using the Form No. 11 in the
Appendix I hereof in the cases where the traditional drug/herbal material is recalled as prescribed
in Point g Clause 1 Article 58 of the Law on Pharmacy.
Article 34. Procedures for revocation of certificates of traditional drug/herbal material
marketing authorization

1. Within 30 days from the date on which the Traditional Medicine Administration of Vietnam
receives the documents specified in Clauses 1, 2, 3 and 4 Article 33 of this Circular from
competent authorities, applicant or manufacturer, the Director of the Traditional Medicine
Administration of Vietnam shall issue a decision on revocation of the certificate of traditional
drug/herbal material marketing authorization.
2. Within 30 days from the date on which the manufacturer or applicant submits the application
form prescribed in Clause 5 Article 33 of this Circular to the Traditional Medicine
Administration of Vietnam, the Director of the Traditional Medicine Administration of Vietnam
shall issue a decision on revocation of the certificate of traditional drug/herbal material
Article 35. Rejection of applications for issuance and extension of the certificate of
traditional drug/herbal material marketing authorization
1. Applications for issuance and extension of the certificate of traditional drug/herbal material
marketing authorization shall be rejected as prescribed in Clauses 2, 3 and 4 Article 100 of the
Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for the
implementation of the Law on Pharmacy.
2. The Minister of Health shall authorize the Director of the Traditional Medicine Administration
of Vietnam to issue a decision on rejection of applications for issuance and extension of the
certificate of traditional drug/herbal material marketing authorization.
Chapter VI
ADVISORY COUNCIL AND ASESSMENT EXPERTS
Article 36. Organizational structure and operation of an advisory council
1. The Advisory Council in charge of providing advice on issuance of the certificate of
traditional drug/herbal materials marketing authorization (hereinafter referred to as “the
Advisory Council”) shall be established by the Minister of Health.
2. The Advisory Council shall consult the Minister of Health shall advise the Minister of Health
about the issuance, extension and adjustment of certificates of marketing authorization of
traditional drugs/herbal materials in Vietnam and traditional drugs whose safety and efficacy still
has to be monitored; recognition of traditional drugs that are exempt from clinical trial or certain
phases of clinical trial; policies on harmonization of regulations on marketing authorization of
drugs and pharmaceutical starting materials with countries in the region and in the world;
policies on manufacturing, import and sale of traditional drugs and herbal materials in Vietnam;
use of traditional drugs and herbal materials on Vietnamese people for assessment the drug
safety and efficacy where necessary.

3. An Advisory Council includes experts in the field of quality, concoction, pharmacology and
clinical pharmacology, laws and management regarding herbal materials and traditional drugs.
The secretary is a representative of the Traditional Medicine Administration of Vietnam.
4. The Advisory Council operates according to the principle: the advice of the Advisory Council
must have legal and scientific grounds and be stated in the minutes of the meeting of the
Advisory Council. The Advisory Council shall be responsible to the Minister of Health for its
advice.
5. The Minister of Health shall issue regulations on organizational structure and operation of the
Advisory Council in charge of providing advice on issuance of drug marketing authorization
number, and mechanism for cooperation between the Advisory Council and assessment expert
group in the process of issuance of drug marketing authorization number at the request of the
Director of the Traditional Medicine Administration of Vietnam.
Article 37. Organizational structure and operation of application assessment experts
1. The Director of the Traditional Medicine Administration of Vietnam shall form group experts
in charge of assessment of applications for traditional drug/herbal materials marketing
authorization (hereinafter referred to as “assessment expert group”).
2. The assessment expert group shall advise the Traditional Medicine Administration of Vietnam
about the assessment of applications and proposals for whether to issue the certificate or adjust
the certificate.
3. The assessment expert group operates according to the principle: the opinions or proposals of
the experts must have legal and scientific grounds and be stated in the assessment record.
Assessment experts shall be responsible to the Director of the Traditional Medicine
Administration of Vietnam and the law for their advice and proposals related to the application
assessment.
4. The Traditional Medicine Administration of Vietnam shall make and promulgate regulations
on criteria for expert selection, organizational structure and operation of assessment expert
groups; annual sign contract with assessment experts; pay experts for opinions and advice; assess
and consolidate assessment results and submit them to the Advisory Council; offer training
courses to experts; evaluate experts’ professional qualification and adherence to regulations.
Chapter VII
IMPLEMENTATION CLAUSE
Article 38. Effect
1. This Circular comes into force from October 28, 2018.

2. Regulations on orient drugs specified in the Circular No. 44/2014/TT-BYT dated November
25, 2014 of the Minister of Health are repealed from the effective date of this Circular.
3. Clause 3 Article 5, Clause 3 Article 6, and Clause 3 Article 7 of the Circular No. 03/2012/TT-
BYT dated February 02, 2012 of the Minister of Health are repealed.
Article 39. Transition clauses
1. Applications for orient drug marketing authorization submitted before the effective date of this
Circular shall be assessed and marketing authorization number shall be granted as prescribed in
the Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health.
2. Regarding the orient drugs and drugs derived from herbal materials granted the marketing
authorization certificate before the effective date of this Circular, before the expiration date of
the marketing authorization certificate issued for 03 months, the applicant shall submit an
application for extension to the Traditional Medicine Administration of Vietnam, which will take
charge and cooperate with the Drug Administration of Vietnam in determining whether they are
herbal drugs or traditional drugs to initiate the procedures for extension of the marketing
authorization certificate as prescribed.
Article 40. Reference clauses
In the cases where a legislative document or regulation referred to in this Circular is changed or
replaced, the newer one shall apply.
Article 41. Implementation
1. The Traditional Medicine Administration of Vietnam shall:
a) provide guidelines for the implementation of this Circular;
b) update the list of traditional drugs and herbal materials granted the marketing authorization
certificate by the Ministry of Health on a periodic basis and information about marketing
authorization of traditional drugs and herbal materials on its website within 15 days from the
date on the decision on issuance of the marketing authorization certificate is issued.
2. Departments of Health of provinces and central-affiliated cities shall inspect the
implementation of the Circular by pharmacy business establishments under their management.
3. Applicants for marketing authorization of traditional drugs and herbal materials shall be
responsible for the legality and accuracy of the applications and origin and quality of traditional
drugs and herbal materials granted marketing authorization.
Article 42. Responsibility for implementation

Director General of Traditional Medicine Administration of Vietnam, Chief of the Ministry
Office, Chief Inspector of Ministry, Directors, General Directors and heads of affiliates of the
Ministry of Health and Departments of Health of provinces and central-affiliated cities,
pharmacy business establishments and other organizations and individuals are responsible for the
implementation of this Circular.
Difficulties that arise during the implementation of this Circular should be promptly reported to
the Traditional Medicine Administration of Vietnam - the Ministry of Health for consideration./.
PP. THE MINISTER
THE DEPUTY MINISTER
Nguyen Viet Tien

Circular 21/2018/TT-BYT: MARKETING AUTHORIZATION OF TRADITIONAL DRUGS AND HERBAL MATERIALS

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Circular 21/2018/TT-BYT: MARKETING AUTHORIZATION OF TRADITIONAL DRUGS AND HERBAL MATERIALS