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THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.: 09/VBHN-BYT
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Hanoi, July 09th 2014
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CIRCULAR
GUIDING THE EXPORT AND IMPORT OF
MEDICINES AND PRIMARY PACKAGING OF MEDICINES
Circular No.
47/2010/TT-BYT dated December 29th 2010 by the Minister of Health
guiding the export and import of medicines and primary packaging of medicines
is amended by the following circulars:
1. Circular No.
45/2011/TT-BYT dated December 21st 2011 by the Minister of Health
amending a number of articles of Decision No. 1570/2000/QD-BYT dated 22/5/2000
by the Minister of Health on the application of the principles ”Good laboratory
practice”; Decision No. 2701/2001/QD-BYT dated 29/6/2001 by the Minister of
Health on the application of the principles ”Good laboratory practice”;
Circular No. 06/2004/TT-BYT dated 28/5/2004 guiding the processing of
medicines; Decision No. 3886/2004/QD-BYT dated 13/11/2004 by the Ministry of
Health on the application of principles and standards ”Good laboratory
practice” according to the recommendation of World Health Organization;
Circular No. 13/2009/TT-BYT dated 01/9/2009 by the Ministry of Health guiding
the advertising and information about medicines; Circular No. 22/2009/TT-BYT
dated 24/11/2009 by the Ministry of Health on registration of medicines;
Circular No. 47/2010/TT-BYT dated 29/12/2010 guiding the export and import of
medicines and primary packaging of medicines (hereinafter referred to as
Circular No. 45/2011/TT-BYT), effective from February 05th 2012.
2. Circular No.
38/2013/TT-BYT dated November 15th 2013 by the Minister of Health
amending a number of articles of Circular No. 47/2010/TT-BYT dated December 29th
2010 by the Minister of Health guiding the export and import of medicines and
primary packaging of medicines (hereinafter referred to as Circular No.
38/2013/TT-BYT), effective from January 01st 2014.
Pursuant to the Law
on Pharmacy No. 34/2005/QH11 dated June 14th 2005;
Pursuant to the Law
on drug prevention and fight No. 23/2000/QH10 dated December 09th
2000 and Law on amendments to the Law on drug prevention and fight No.
16/2008/QH12 dated June 03rd 2008;
Pursuant to the
Decree No. 188/2007/ND-CP dated December 27th 2007 by the Government defining
the functions, tasks, powers and organizational structure of the Ministry of
Health;
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Pursuant to the Decree No. 58/2003/ND-CP
dated May 29th 2003 providing for the control over the import,
export and transit through Vietnam’s territory the narcotic substances,
precursors, narcotic drugs and psychotropic medicines;
Pursuant to the Decree No. 12/2006/ND-CP dated
January 23rd 2006 by the Government detailing the implementation of
the Law on Trade applicable to international goods trade and the activities of
agents, trading, processing, and transiting of goods with foreign partners;
Pursuant to the
Decision No. 151/2007/QD-TTg dated September 12th 2007 by the Prime
Minister promulgating regulations on the import of medicines without
registration number in Vietnam;
The Minister of
Health promulgates the Circular guiding the export and import of medicines and
primary packaging of medicines as follows.[1]
Chapter
I
GENERAL PROVISIONS
Article
1. Scope of regulation
1. This Circular provides for the export and
import of medicines and primary packaging of medicines.
2. Exported and imported medicines through
non-trade route to heal for the importers’, exporters’ own and their family are
not subject to this Circular.
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In this Circular,
these terms can be construed as follows:
1. Country of
origin means the country that produces final dosage forms and/or ships
goods lots or the country from which the products are shipped to the importing
country.
2. A manufacturing
establishment is an establishment performing at least one stage of production
and/or shipping finished products.
3. Commercial
packaging of medicines means packaging containing medicines and circulated
together with medicines. Commercial packaging of medicines includes two
types:
- Primary packaging
means packaging containing in physical contact with medicines;
- Secondary packaging
means packaging used to package one or more medicine units having primary
packaging.
4. Radioactive
substances mean substances emitting radiation due to nuclear fission,
nuclear energy transitions, having specific radioactivity levels or total
radioactivity levels of higher than the exemption rate.
5. Radioactive
pharmaceutical substances mean pharmaceutical substances that contain
radioactive substances used for diagnosis and medical treatment.
6.
Radiopharmaceuticals mean medicines that contain one or more radioactive
pharmaceutical substances used for diagnosis or treatment.
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Article
3. Conditions and scope of organizations/individuals involving in the export
and import of medicines and primary packaging of medicines
1. Regarding traders
being Vietnamese enterprises:
a) Any enterprises having Certificate of
eligibility for medicine trading and having medicine storehouse conformable
with the "Good storage practice” (GSP) may import directly or assume
entrustment to import finished medicines, ingredients for producing medicines,
vaccine, biologics serving medicine, medicines made from herbal ingredients,
oriental medicines, radiopharmaceuticals eligible for exemption from
declaration/licensing according to the business scope written on the
Certificate of eligibility for medicine trading and the GSP Certificate;
b) Any enterprises
trading in medical equipment and enterprises having the Certificate of
eligibility for medicine trading may import directly or assume entrustment to
import biologics for diagnosis of In Vitro;
c) Any enterprise having the Certificate of
eligibility for medicine trading and the Certificate of conformance with the
“Good medicine manufacturing practice” (GMP) may import ingredients for their
own medicine production or sell them to another medicine-producing enterprises;
d) Any medicine-producing enterprise having the
Certificate of eligibility for trading medicine made from herbal ingredients
may import herbal ingredients for their own production or sell them to another
medicine-producing facilities or oriental medical examination and treatment
facilities;
dd) Any enterprise
having the Certificate of eligibility for medicine trading and the effective
License for carrying out radiations works issued by a competent agency may
import directly radiopharmaceuticals not eligible for exemption from
declaration/licensing.
2. Any traders being
foreign-invested enterprises in Vietnam that has the Certificate of eligibility
for medicine trading (including the scope of medicine production) may import
ingredients for producing their own medicines. The export/import of medicines
that not serves the enterprise’s medicine production shall be guided by the
Ministry of Health in other documents.
3. Vietnamese trader
having the Certificate of eligibility for medicine trading may export, give
entrustment, assume entrustment for exporting medicines, excluding narcotic
drugs, psychotropic medicines, medicine precursors and radiopharmaceuticals.
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5. Any
organizations/individuals that is not a trader may give entrustment or assume
entrustment with importing medicines serving their own demand depending on the
concluded contract according to the law, excluding narcotic drugs, psychotropic
medicines, medicine precursors and radiopharmaceuticals.
6. Representative offices of foreign traders
having Licenses for operation involving medicines and ingredients for making
medicines in Vietnam, Vietnamese traders having the Certificate of eligibility
for medicine trading may import medicines serving circulation registration
(including medicines used for testing/inspection as required by the
registration of medicines).
7. Any establishments
having function of research and testing and any medicine-producing
establishments are permitted to import medicines for research and testing.
8. Medical examination
and treatment establishments of provinces, cities, medical line establishments
and organizations of Vietnam (hereinafter referred to as the Vietnam parties)
are allowed to receive donated medicines from charitable organizations,
non-governmental organizations, foreign individuals, overseas Vietnamese
(referred to as foreign parties) and are responsible for using medicines
effectively, safely, reasonably and conformably to donation purposes.
9. Organizations and
individuals having clinical testing medicine may import medicines for clinical
testing according to research on testing medicines on clinique approved by the
Ministry of Health.
10. Organizations and
individuals having research on bioavailability/bioequivalence that is approved
by a specialized technical agency authorized by the Ministry of Health may
import medicines for the study of the bioavailability/bioequivalence.
11. Traders are
allowed to import/export primary packaging of medicines.
12. Regarding foreign traders supplying
medicines into Vietnam:
a) Any foreign traders
supplying medicines, herbal ingredients, herbal medicines, oriental medicines
into Vietnam must be an enterprise having License for operation involving
medicines and medicine ingredients in Vietnam;
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c) If medicines are needed
for medical prevention and treatment and medicine ingredients are needed for
the production of medicines in Vietnam but enterprises having the License for
operation involving medicines and medicine ingredients in Vietnam refuse to
supply or supply insufficiently, Drug administration of Vietnam - the Ministry
of Health shall consider and decide to permit the import from reputable
medicine suppliers in the world.
Article
4. General provisions on import/export of medicines
1. Quality of imported
medicines and packaging in physical contact with imported medicines
Any trader producing,
importing, exporting, supplying, giving entrustment/assuming entrustment with
importing/exporting medicines and/or primary packaging of medicines shall be
responsible for quality and safety of imported medicines according to the
regulations in the Law on Pharmacy, the Law on Commerce and other current
provisions on medicine quality control.
2. Duration of
imported medicines:
a) If a finished
medicine imported into Vietnam has duration of greater than 24 months, the
remaining duration of it must be at least 18 months from the date of arrival in
Vietnam. If the medicine has duration of less than 24 months, its
remaining duration must be at least 12 months from the date of arrival in
Vietnam.
b) Any vaccine/medical
biologics not having registration number that is imported into Vietnam must
have remaining duration of at least 2/3 of its duration from the date of
arrival in Vietnam;
c) Any vaccine/medical
biologics having effective registration number that is imported into Vietnam
must have remaining duration of at least 1/2 of its duration from the date of
arrival in Vietnam;
d) Any biologics for diagnosis of In Vitro
having duration of equal to or less than 12 months that is imported into
Vietnam must have remaining duration of at least 03 months from the date of
arrival in Vietnam;
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e) Donated medicines,
rare medicines, medicines serving treatment of hospitals having duration of
equal to or greater than 24 months must have remaining duration of at least 12
months from the date of arrival in Vietnam. If the medicine has duration of
more than 24 months, the remaining duration must be at least 1/3 of its
duration from the date of arrival in Vietnam;
d) Medicines/medicine ingredients unconformable
to the regulations on duration of medicines specified in points a, b, c, d, dd
of this clause but satisfy quality standards and are necessary for importing
for medical treatment and medicine production in Vietnam, Drug administration
of Vietnam - the Ministry of Health shall consider, decide and takes
responsibility for permitting the import.
3. Requirement on
testing sheet:
When carrying out
customs clearance procedures, any enterprise importing medicines/primary
packaging of medicines must present to the border - gate customs the original
copy of the testing sheet of the production establishment certifying the conformance
with quality standards for each lot of imported medicines of the manufacturer,
excluding herbal ingredients and medicines specified in Articles 12, 13, 14,
15, 17 and 18 of this Circular.
If multiple
establishments involve in the production of medicines, the original copy of
testing sheet of the manufacturer or the testing sheet of the final packaging
establishment or the establishment responsible for shipping is accepted.
The border - gate
customs shall retain the photocopy of testing sheet that is appended seal of
the importing enterprise.
4. Intellectual
property right on medicines/primary packaging of medicines:
Any trader involving
in the production, import, export, supply or entrustment with
importing/exporting of medicines/primary packaging of medicines must be
responsible for the intellectual property right of medicines/primary packaging
of medicines that his/her establishment produces, imports, exports, supplies or
gives entrustment/assume entrustment with importing/exporting.
5. Testing, clinical
trials of vaccines and medical biologics being serum containing imported
antibodies:
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b) If the
vaccine/medical biologics being serum containing antibodies used for disease
prevention and treatment fails to get number of registration for import for
national programs and projects, a clinical trials according to the regulation
in Decision No. 01/2007/QD-BYT dated 11/01/2007 by the Minister of Health.
If a vaccine/medical
biologic being serum that contains antibodies used for disease prevention and
treatment fails to get the number of registration for selling but has undergone
pre-inspection of World Health Organization and have been sold worldwide and provided
for Vietnam as aid by international organizations cooperating with Vietnam in
medicine like WHO, UNICEF, etc., then depending on specific case/on a
case-by-case basis, Drug administration of Vietnam - the Ministry of Health may
require the proof of operation of cold chain and satisfactory results of
clinical trials in the field before its use is allowed.
c)
If the vaccine/medical biologic being serum containing antibodies used for
disease prevention and treatment is imported according to the regulations in
Article 13, 14, 15 and 16 of this Circular, Drug administration of Vietnam -
the Ministry of Health may, if necessary, require the clinical trials in
the field; such vaccine/medical biologic shall be used only when the result of
clinical trials in the field is conformable with safety standards.
6. Labels of imported
medicines:
Labels of imported
medicines shall comply with the regulations in Decree No. 89/2006/ND-CP dated
30/9/2006 by the Government and regulations in Circular No. 04/2008/TT-BYT dated
12/05/2008 by the Minister of Health, excluding labels of medicines specified
in Articles 12, 13, 14, 15, 16, 17 and 18 of this Circular.
7. Declaration and
re-declaration of prices of medicines:
The declaration and
re-declaration of prices of imported medicines shall comply with the
regulations in Joint Circular No. 11/2007/TTLT-BYT-BTC-BCT dated 31/8/2007 by
the Ministry of Health - the Ministry of Finance - The Ministry of Industry and
Trade.
8. Reporting:
a)
Within 10 days from the day on which the vaccine/medical biologics being serum
that contains antibodies is imported and transported to the storehouse, the
importing enterprise shall send the report on import of each imported lot to
Drug Administration of Vietnam - the Ministry of Health and the National
Institute for Control of Vaccine and Biologicals (Form No. 1a).
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c) Regarding enterprises importing medicines for
display at shows, exhibitions or fairs and other temporary imports/re-exports:
within 10 days after the shows, exhibitions or fairs of from the expiration of
temporary import, medicines shall be re-exported and the enterprise shall
report to the Drug Administration of Vietnam - the Ministry of Health the
quantity and situation of re-export (using form No. 1c)
9. Fees
Any enterprise importing medicines shall pay
fees according to the regulations in Decision No. 44/2005/QD-BTC dated
12/07/2005 by the Minister of Finance, Decision No. 59/2008/QD-BTC dated
21/07/2008 amending to Decision No. 44/2005/QD-BTC dated 12/07/2005 by the
Minister of Finance and relevant legal documents.
10. Duration of effect
of the License for export/import of medicines:
The License for export/import of medicines is
effective for 01 year from the day it is signed.
11. Legal documents in
medicine import documents:
a) The Certificate of
a Pharmaceutical Product (CPP), the Free Sale Certificate (FSC) or the
Certificate of Good medicine manufacturing practice (GMP) or similar
certificates for biologics for diagnosis of In Vitro may be submitted with
original copies or the Vietnam’s translation supposed that the regulations
specified for each type of certificate prescribed in points b, c or d of this
clause and general provisions are fulfilled as follows:
- Any original copies
included in the documents must have signature, full name, position, date of
issue and seal of a competent agency of the country issuing the certificate;
must be legalized consulate in a diplomatic mission of Vietnam according to the
regulations on consular legalization, excluding legal documents issued by
competent authorities of the countries signed the Agreement on Judicial
assistance with Vietnam;
- Any photocopies
included in the documents shall be certified conformable according to Vietnam’s
law provisions on authentication of the photocopies from the original copies by
a competent agency of Vietnam;
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- Each certificate
shall include their duration and shall be effective at the time of appraisal;
the written extension of the certificate is not accepted. In case certificates
do not include duration, only certificates that are issued within 24 months are
accepted.
b) Apart from the
regulations in point a of this clause, the Certificate of a Pharmaceutical
Product shall satisfy the following regulations:
- There shall be a
certificate of medicine permissible to sell at country of origins, if the
medicine is not sold at the country of origin, the supplier shall provide Drug
Administration of Vietnam - the Ministry of Health with explanation for
consideration;
- If medicine is
produced through multiple stages in multiple countries and the unique country
of origin cannot be determined, medicine importing establishment must present
the CPP of the country in which the final dosage form is produced or the
shipping country. If the CPP of neither of the countries above are presented,
Drug Administration of Vietnam - the Ministry of Health shall consider
accepting the CPP of the country from which products are transported to the
importing country;
- If neither of the
CPP above are presented, the CPP of medicine shall be accept only when it is
issued by any of the countries including England, France, Germany, USA, Japan,
Australia, Canada or an agency of assessment and evaluation of medical products
in Europe – EMEA;
- The Certificate
shall be issued by a pharmaceutical management agency (according to the list
posted by WHO on http://www.who.int) of the country of
origin according to the form regulated by WHO applicable to the Quality
certification system for pharmaceutical products in international trade.
c) Apart from the
regulations in point a of this clause, the Free sale certificate shall satisfy
the following regulations:
- There shall be a
certificate of medicine permissible to sell at country of origins, if the
medicine is not sold at the country of origin, the supplier shall provide Drug
Administration of Vietnam - the Ministry of Health with explanation for
consideration;
- The Certificate
shall be issued by a competent agency of the country of origin and shall
contain sufficiently the information about components, contents, dosage form
and its duration.
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Article
5. Formulation of order forms, language and form of documents
1. Order form of
import/export of medicines/primary packaging of medicines shall be made in 03
copies according to the form applicable for specific type of medicines
according to the regulations in this Circular. After being approved, 02 copies
shall be retained in Drug Administration of Vietnam - the Ministry of Health
and the other shall be sent to medicine importing/exporting enterprise. The
copies sent to medicine importing/exporting enterprise shall be stamped “Bản gửi
doanh nghiệp” (dispatch for enterprise) for making custom procedures at border
gates. The order form of import/export of a narcotic drug, psychotropic
medicine or a medicine precursor including the form of element or compound that
has an effective registration number for selling shall be made in 02 copies.
2. If an enterprise is
entrusted with importing/exporting medicines, name of the company giving
entrustment shall be written on the order form.
3. Documents and
papers enclosed with the order form shall be presented on A4 paper and bounded
firmly into 01 set. Information in the document shall be arranged according to
the order in the table of contents. Separated parts shall be numbered for easy
reference and shall be verified by the importing enterprise on the first page
of each part of the set of documents; its cover page shall contain name of the
importer, number of order, date of formulation of order and type of order.
4. Language of
medicine import documents:
Documents on import of
foreign medicines shall be written in Vietnamese or English. If the document is
written in English, information in the instruction shall be written in
Vietnamese, excluding the following information that is allowed to be written
in other languages with Latin roots:
a) Proprietary names,
generic names or international nonproprietary names of medicines;
b) International
nonproprietary names or scientific names of ingredients, ingredient quantities
of medicines in case they are unable to translate into Vietnamese or translated
into Vietnamese but it is nonsense;
c) Name and address of
the foreign enterprises of producing/conceding production of medicines.
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a) Name of medicine;
b) Dosage form;
c) The formula for a
dose unit (applicable to single-dose medicine) or the same content
concentration (applicable to multi-dose medicine);
d) Manufacturer;
Article 6. Other provisions
1. Imported medicines must satisfy the
regulations in clause 1 Article 36 of the Law on Pharmacy to be sold.
2. Imported medicines
serving national medical projects/target programs, donated medicines; imported
medicines for clinical trials, making registration form, serving the research,
testing, inspection; imported medicines for display at shows/exhibitions/fairs
shall be used for right purposes, right objects; sale of such medicines is
forbidden.
3. When the donated
medicines imported by organizations/individuals specified in clause 8 Article 3
of this Circular have been received, a Council shall be established for
inventorying, assessing and classifying and warehousing for management. Only
medicines satisfying quality standards and that are unexpired are permissible
to use for medical treatment. Regarding forbidden medicines, a Council shall be
established for destroying them according to the regulations in Circular No.
09/2010/TT-BYT dated April 28th 2010.
Heads of units receiving donated medicines must
take fully responsibilities for quality of medicines and shall use medicines
effectively, reasonably and safely.
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a) Medicines are allowed to be sold in the
country. Vaccines/medical biologics being serums that contain antibody are on
the list of vaccines/medical biologics recommended by Health Organization;
b) Medicines satisfy the actual needs of the
receiving units and national policies on medicines of Vietnam;
c) Medicines are not on the list of narcotic
drugs, list of medicine ingredients and finished medicines banned from import
for making medicines for human (excluding the import of medicines serving
national programs and projects that are approved by the Government);
d) Medicines have clear origin and satisfy the
standards for quality, safety and efficiency in both the donation provider and
Vietnam. Donated vaccines/medical biologics have testing sheet proving the
conformance with quality standards issued by the national testing office of the
home country or agencies in charge of the imported goods and have undergone
quality assessment by National Institute for Control of Vaccines and
Biologicals before importing;
dd) Medicines are packed in suitable packaging
on which name of medicines, active ingredients, contents, dosage forms, packing
and instructions are written; a detailed list is enclosed with each packaging
unit
e) In special case, donated medicines serving a
researching program fails to satisfy regulations in points a, b, c, d and dd of
this clause may be received depending on the legal and technical documents
relating to the researching program.
5. Herbal ingredients used for producing,
preparing and medicines in medicine production establishments, medical
examination and treatment facilities using oriental shall satisfy quality
standards and shall be supplied by establishments eligible for trading
medicines.
6. Apart from regulations in this Circular,
radiopharmaceuticals shall comply with law provisions relating to radiation
safety.
Chapter
II
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Article
7. Import of medicines and primary packaging of medicines
1. The import of
finished medicines and medicine ingredients on the List in the Appendix to
produce medicines for human is forbidden.
2. Medicines having
effective registration numbers, excluding narcotic drugs, psychotropic
medicines and medicine precursors may be imported on demand without application
for the license for import or verification of importing orders.
3. Medicines and
primary packaging of medicines that are imported subject to having the license
for import issued by Drug Administration of Vietnam - the Ministry of Health
include:
a) Narcotic drug,
psychotropic medicine or medicine precursor including the form of element or
compound that has an effective registration number for selling;
b) Finished medicine,
medicine ingredient, vaccine, medical biologics without registration number;
c) Packaging in physical contact with medicine.
Article
8. Export of medicines and primary packaging of medicines
1. The export of narcotic drugs, psychotropic
medicines, medicine precursors including the form of element or compound shall
have the license for export issued by Drug administration of Vietnam - the
Ministry of Health.
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Chapter
III
APPLICATION
AND PROCEDURES FOR IMPORT OF MEDICINES/PRIMARY PACKAGING OF MEDICINES AND
APRAISAL OF IMPORTED MEDICINES
Section
1. IMPORT OF MEDICINES WITH EFFECTIVE REGISTRATION NUMBERS
Article
9. Narcotic drugs, psychotropic medicines and medicine precursors
1. Application:
a) Importing order
form (Forms No. 2a, 2b);
b) Form No. 3.
2. Procedures:
The enterprise shall submit an application to
Drug Administration of Vietnam - the Ministry of Health. Within 15 working days
from the day on which the satisfactory application is received, Drug
Administration of Vietnam - the Ministry of Health shall issue the license for
import. If the application is rejected, Drug Adminstration of Vietnam - the
Ministry of Health shall send the enterprise a containing explanation.
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The enterprise shall
carry out procedures at border-gate customs and present the list of imported
medicines (Form No. 4) enclosed with the original copies or conformable
notarized copies of the following documents:
a) The License for
selling products or Decision on issuance of registration number for selling;
other documents about permission for modification (if any);
b) License for operation involving medicines and
medicine ingredients in Vietnam, applicable to foreign companies supplying
medicines, excluding traders specified in points b and c clause 13 Article 3 of
this Circular.
Section
2. IMPORT OF MEDICINES WITHOUT REGISTRATION NUMBERS
Article
11. Finished medicines containing drug substances without registration numbers
or drug substances with registration numbers that are not satisfactory,
medicine biologics used for disease prevention, treatment and diagnosis
1. Conditions and
quantity of medicines eligible for consideration for import licenses:
The import of such medicines shall comply with
regulations in Article 7 Decision No. 151/2007/QD-TTg dated September 12th 2007
by the Prime Minister promulgating regulations on the import of medicines
without registration number in Vietnam.
2. Application:
a) Importing order
form (Forms No. 5a, 5b, 5c, 5d, 5dd);
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c) Standards and
methods for medicine quality inspection;
d) Samples of label
and instruction leaflet with the seal of the importing enterprise, including:
01 original set of labels enclosed with the instruction leaflet of the medicine
that is actually used in the country of origin (except for vaccines and medical
biologics); 02 sets of labels that are planned to be used in Vietnam enclosed
with the Vietnamese instruction leaflet;
dd) Form No. 3;
e) Pre-clinic and clinic documents, applicable
to medicines containing new drug substances, medicines with new compounding of
such drug substances.
3. Procedures:
The enterprise shall
submit documents to Drug Administration of Vietnam - the Ministry of Health.
Within 20 working days from the day on which the satisfactory application is
received, Drug Administration of Vietnam - the Ministry of Health shall
consider issuing the license for import. If the application is rejected, Drug
Administration of Vietnam - the Ministry of Health shall send the enterprise a
containing explanation.
Article
12. Rare medicines, medicines for treatment activities of hospitals in special
cases
1. Application:
a) Importing order
form (Forms No. 6a);
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c) Documents specified
in points b, c, d, dd and e clause 2 Article 11, excluding the following cases:
- If an enterprise
wishing to organize a GPP pharmacy chain needs to import medicines on the list
of rare medicines and/or medicines imported for treatment activities hospitals
in special cases to sell at GPP pharmacies in its system, then such enterprise
shall make a written application paper containing the explanation for not
presenting the original testing sheet and documents and shall take all
responsibilities for quality of the imported medicines;
- Any enterprise
importing medicines that are on the list of rare medicines, medicines imported
for treatment activities hospitals in special cases or medicines with active
ingredients, concentrations, contents, dosage forms unregistered for selling in
Vietnam but mentioned in specialized documents shall submit the documents
specified in clause 2 Article 11 of this Circular and the original copy of
testing sheet of the imported medicines; otherwise, a writing containing
reasons for not presenting the documents about the imported medicines, the
original copy of testing sheet of the medicines and commitment to ensure the
quality of the imported medicines and a report on medicine use (the need, the
safety, effect of medicines) shall be enclosed with the application.
2. Procedures:
The enterprise shall
submit the application to Drug Administration of Vietnam - the Ministry of
Health. Within 07 working days from the day on which the satisfactory
application is received, Drug Administration of Vietnam - the Ministry of
Health shall consider issuing the license for import. If the application is
rejected, Drug Administration of Vietnam - the Ministry of Health shall send
the enterprise a containing explanation.
Article
13. Vaccines, medical biologics for special treatment of treatment facilities,
inoculation facilities and testing facilities
1. Application:
a) Importing order
form (Forms No. 7a);
b) Form No. 7b;
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dd) Enclosures (if
any) including: the Certificate of GMP, the Certificate of ISO issued by
competent agencies (applicable to biologics for diagnosis of In Vitro), the
License for sale of vaccines/medical biologics, the License for sale of
vaccines/medical biologics issued by some other countries where such
vaccines/medical biologics are sold. In special cases, if the company fails to
submit sufficiently the documents or the vaccines/medical biologics are
unconformable to the regulations in points b, c and d clause 2 Article 4 of
this Circular but are necessary, Drug administration of Vietnam - the Ministry
of Health shall consider and decide.
2. Procedures:
The enterprise shall
submit the application to Drug Administration of Vietnam - the Ministry of
Health. Within 15 working days from the day on which the satisfactory
application is received, Drug Administration of Vietnam - the Ministry of
Health shall consider issuing the license for import and request the applicant
importing vaccines/medical biologics to submit the application and samples to
National Institute for Control of Vaccine and Biologicals if necessary.
If the application is
rejected, Drug Administration of Vietnam - the Ministry of Health shall send
the enterprise a containing explanation.
Article
14. Medicines satisfying urgent needs for disease prevention and fighting and
disaster recovery
1. Application: Forms
No. 8;
2. Procedures:
The enterprise shall
submit documents to Drug Administration of Vietnam - the Ministry of Health.
Within 05 working days from the day on which the satisfactory application is
received, Drug Administration of Vietnam - the Ministry of Health shall
consider issuing the license for import. If the application is rejected, Drug
Administration of Vietnam - the Ministry of Health shall send the enterprise a
containing explanation.
Article
15. Medicines for national target programs for health
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a) Importing order
form (Forms No. 9);
b) Documents of
competent agencies about the import of medicines serving national target
programs for health (if necessary, Drug Administration of Vietnam - the
Ministry of Health may request the documents specified in points b, c, d and e
clause 2 Article 11 of this Circular);
c) Regarding vaccines/medical biologics being
serums that contain antibodies used for disease prevention and fighting, apart
from documents specified in points a and b of this Article, the following
documents are required:
- A certificate of a
competent agency of the home country permitting the sale or export of vaccines/medical
biologics;
- The GMP Certificate;
- The testing sheet proving the conformance of
quality standards for vaccines/medical biologics issued by the national testing
agency or other competent agencies of the home country in charge of the imported
vaccines/medical biologics (certified true copy by the importing enterprise);
- Results of clinical trials according to the
regulation in point b clause 5 Article 4 of this Circular.
d) If vaccines/medical biologics are imported
according to national or international bidding in Vietnam and documents
specified in bullets 1, 2 and 3 point c clause 1 of this Article are checked by
the program when checking bid documents, then such documents are not required.
2. Procedures:
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b) Within 15 working
days from the day on which the satisfactory application is received, Drug
Administration of Vietnam - the Ministry of Health shall consider issuing the
license for import. If the application is rejected, Drug Administration of
Vietnam - the Ministry of Health shall send the enterprise a containing explanation.
Article
16. Donated medicines
1. Application:
a) An official
application for import of the donation receiving establishment;
b) The list of donated
medicines (Form No. 10);
c) A document issued
by a competent agency on permission for the establishment to receive donated
medicines;
d) Regarding vaccines/medical biologics being
serums that contain antibodies used for disease prevention and fighting, apart
from documents specified in points a, b and c clause 1 of this Article,
documents specified in bullets 1, 2 and 3 points c clause 1 Article 15 of this
Circular.
2. Procedures:
The importing
establishment shall submit an application to local Department of Health, if the
medicine contains new drug substances or is compounded by drug substances that
are on sale, vaccines, medical biologics, the application shall be sent to Drug
Administration of Vietnam - the Ministry of Health. Within 15 working days from
the day on which the satisfactory application and order form are received, Drug
Administration of Vietnam - the Ministry of Health shall consider issuing the
license for import. If the application is rejected, Drug Administration of
Vietnam - the Ministry of Health shall make a response containing explanation.
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The import of such
medicines shall comply with regulations in Article 7 Decision No.
151/2007/QD-TTg dated September 12th 2007 by the Prime Minister promulgating
regulations on the import of medicines without registration number in Vietnam.
1. Application:
a) Importing order
form (Forms No. 11a, 11b, 11c);
b) The draft of
research on clinical trials of medicines approved by the Minister of Health,
applicable to medicines imported for clinical testing;
c) The research on
bioavailability/bioequivalence that is approved by a specialized technical
agency authorized by the Ministry of Health, applicable to medicines that are
imported for research on bioavailability/bioequivalence;
d) The written approval of a competent agency
for running the research project or request of the competent agency for the
import of medicines used for testing/inspection;
dd) If an establishment
producing/researching/testing medicines wishes to import medicines for their
own research/testing, an application shall be enclosed containing the
commitment that the imported medicines are used for their own research/testing
only.
The quantity to be
imported must conform to the scale of production, research, testing, and
inspection. In case after trial production, imported ingredients are surplus
and the company wishes to put them into production of a type of medicine
granted the registration number, the company shall report to the Drug
Administration of Vietnam the quantity of existence, expiry date and status of
quality and apply for using such ingredients to produce finished medicines.
e) Photocopies of the
Certificate of eligibility for medicine trading with the seal of the
enterprise, applicable to enterprise initially applying for importing medicines
for use as samples.
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The importing
establishment shall submit an application to Drug Administration of Vietnam -
the Ministry of Health. Within 15 working days from the day on which the
satisfactory application and order form are received, Drug Administration of
Vietnam - the Ministry of Health shall consider issuing the license for import.
If the application is rejected, Drug Administration of Vietnam - the Ministry
of Health shall send the establishment a response containing explanation.
Article
18. Medicines for display at shows, exhibitions or fairs and other cases of
temporary import of medicines
The import of such
medicines shall comply with regulations in clause 3 Article 9 of Decision No.
151/2007/QD-TTg dated 12/9/2007 by the Prime Minister and regulations in
Article 12 of Decree No. 12/2006/ND-CP dated January 23rd 2006 by
the Government.
Article
19. Medicine ingredients, herbal ingredients without registration number,
primary packaging of medicines
1. Medicine
ingredients may be imported according to the regulations in Clause 2 or Clause
3 of this Article.
2. Import
according to the List of medicine ingredients permissible to import issued by
Drug administration of Vietnam (the license of import is not required).
a) The List of
medicine ingredients permissible to import without the license issued by Drug
administration of Vietnam includes the drug substances excluding the
ingredients on the list of narcotic drugs, psychotropic medicines, medicine
precursors. If the production establishment modifies the origin or quality
standards of any ingredients, the production establishment shall make an
application for modification according to the regulations in Appendix II
enclosed with Circular No. 22/2009/TT-BYT dated November 24th 2009 by the
Minister of Health and shall import the ingredients only when the written
approval for the modification issued by Drug administration of Vietnam is
received.
b) Procedures for
announcement
- The Ministry of
Health (Drug administration of Vietnam) shall publish the List of medicine
ingredients permissible to import (without the license) on the website of Drug
administration of Vietnam (www.dav.gov.vn) according o
the Form No. 16 enclosed with this Circular.
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c) Importing
enterprises
A medicine production
establishment that is issued with registration number shall import ingredients
conformable to the List that is issued.
A trading enterprise
having function of importing medicine ingredients is allowed to import the
ingredients on the List of medicine ingredients permissible to import without
license issued by Drug administration of Vietnam.
d) Application and procedures
for import
- Any production
establishment wishing to import ingredients for producing medicines and
enterprise wishing to import ingredients for trade shall carry out customs
procedures at border gates to import ingredients on the List issued by Drug
administration of Vietnam;
- The medicine
production establishment shall present the Certificate of eligibility for
producing medicines or the Certificate of Good medicine manufacturing practice
according to the regulations in points c and d clause 1 Article 3 of this
Circular.
- The enterprise
importing ingredients for trade shall present the Certificate of eligibility
for medicine trading (under form of wholesales or import/export of medicines)
and the GSP Certificate with appropriate scope of business according to the
regulations in point a clause 1 Article 3 of this Circular.
- Deadline for
importing medicine ingredients under the form of announcement is equal to the
validity time limit of registration numbers of medicines made of such
medicines;
- Any foreign
enterprises providing medicine ingredients to Vietnam must have a License for
operation on medicines and medicine ingredients in Vietnam which is still
effective according to the regulations in clause 12, Article 3 of this
Circular.
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a) Medicine
ingredients imported under the form of import license include:
- Medicine ingredients
other than those permissible to import under the form of announcement
prescribed in clause 2 of this Article;
- Ingredients on the
list of narcotic drugs, psychotropic medicines and medicine precursors;
- Ingredients being
excipients, capsules, primary packaging of medicines;
- Ingredients used for
research/testing;
b) Foreign enterprises
importing ingredients under the form of import license and foreign enterprises
supplying medicine ingredients to Vietnam are specified in Article 3 of this
Circular.
c) Application for
import license
- Importing order form according to Form No.
12a, 12b, 12c, 12d, or 12dd enclosed with this Circular.
- The Table of quality
standards and the table of testing methods for ingredients, herbal ingredients,
primary packaging of medicines, applicable to ingredients/packaging with
quality standards and testing methods of the manufacturer or the photocopied
monograph of quality standards of the pharmacopoeia unless otherwise applied by
pharmacopoeia of Europe, England, the U.S, Japan or the World.
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d) Procedures
The enterprise shall
submit an application to Drug Administration of Vietnam - the Ministry of
Health. Within 07 working days from the day on which the satisfactory
application is received, Drug Administration of Vietnam - the Ministry of
Health shall consider issuing the license for import.
Regarding medicine
ingredients being narcotic drugs, psychotropic medicines or medicine
precursors, within 15 working days from the day on which the satisfactory
application is received, Drug Administration of Vietnam - the Ministry of
Health shall consider issuing the license for import.
If the application is
rejected, Drug Administration of Vietnam - the Ministry of Health shall send
the enterprise a response containing explanation.
dd) A License for
export/import of medicine ingredients without registration number is effective
for 02 year from the day it is signed.”
Article 20. Radiopharmaceuticals
1. Regarding
radiopharmaceuticals exempt from declaration/license: regulations in Article 11
of this Circular shall be complied with.
2. Regarding
radiopharmaceuticals not excepted from making declaration/license: regulations
in Article 11 of this Circular shall be complied with and the License for
carrying out radiations works that a competent agency issues to enterprise
directly trading radiopharmaceuticals is required.
Section
3. INSPECTION OF IMPORTED MEDICINES
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1.
Application:
a) An inspection-submitting slip;
b) A summary of the production and inspection of
the lot of imported vaccines/medical biologics (a photocopy verified with seal
by the manufacturer);
c) The license for shipping
issued by a competent agency of the home country or other equivalent agencies
enclosed with each imported lot (a photocopy verified with seal by the Director
of the importing enterprise);
d) Evidences of safety and quality of cold chain
in the transport of imported goods.
e) Samples of vaccines/medical biologics being
serums containing antibodies that are imported for inspection (quantity of
samples according to regulations for specific type of vaccines/medical
biologics).
2. Procedures:
The importing enterprise shall submit an
application to National Institute for Control of vaccine and biological. Within
07 working days from the day on which the satisfactory application and samples
are received, National Institute for Control of Vaccine and Biologicals shall
send the enterprise a written response about quality of vaccines/medical
biologics and safety on experimented of vaccines/medical biologics.
Chapter IV
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Article
22. Narcotic drugs, psychotropic medicines and medicine precursors
1. Application:
a) Importing order
form (Forms No. 13a, 13b);
b) A written
permission for export issued by a competent agency of the importing country
(the original copy, the photocopy or the Vietnam’s translation satisfying the
regulations in bullets 1, 2 and 3 points a clause 11 Article 4 of this
Circular).
c) Commercial
addictive drugs in combination form specified in clause 2 Article 1 of Circular
No. 10/2010/TT-BYT dated 29/4/2010; commercial psychotropic drugs, precursors
in combination form specified in clause 2 Article 1 of Circular No.
11/2010/TT-BYT dated 29/4/2010 that are export as samples for registration,
fairs, exhibitions, research are not required to have the documents according
to the regulations in point b clause 1 of this Article but a written
explanation containing reasons and purposes of exporting medicines of the
exporting enterprises;
d)
2. Procedures:
Within 15 working days from the day on which the
satisfactory application and order form are received, Drug Administration of
Vietnam - the Ministry of Health shall consider issuing the license for export.
If the application is rejected, Drug Administration of Vietnam - the Ministry
of Health shall send the enterprise a written response containing explanation.
Article
23. Other medicines not being narcotic drugs, psychotropic medicines nor
medicine precursors in form of element or compound, primary packaging of
medicines
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1. Application:
An application form
for FSC or CPP (Form No. 14);
If the importing
country requests the establishment to submit the FSC or CPP according to their
form, Drug Administration of Vietnam - the Ministry of Health may consider
issuing the FSC depending on such form.
2. Procedures:
a) Procedures for
reissuance of the FSC shall comply with regulations in Article 13 of Decision
No. 10/2010/QD-TTg dated 10/2/2010 by the Prime Minister.
b) The establishment
exporting medicine is not required to carry out the procedures for registering
the trader dossier to be issued with the FSC.
c) Within 05 working
days from the day on which the satisfactory application is received, Drug
Administration of Vietnam - the Ministry of Health shall issue the FSC or the
CPP (Form No. 15a, 15b).
Chapter V
ACTIONS AGAINST
VIOLATIONS
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1. Any
exporting/importing enterprises that forges or modify legal documents/papers of
a Vietnamese or foreign functional agency; uses a fake seal or forges the
signature or seal of the importing establishment, production establishment or a
relevant establishment in the application for importing/exporting medicines,
Drug Administration of Vietnam - the Ministry of Health shall issue a Official
Dispatch for warning the establishment and stop receiving/considering of the
application of such enterprise, to specific:
a) The
receipt/consideration of the application for exporting/importing medicine of
the enterprise shall be suspended for 03 months, applicable to the initial
violation;
b) The
receipt/consideration of the application for exporting/importing medicine of
the enterprise shall be suspended for 06 months to 12 months, applicable to the
violation that is committed 02 times in 12 months;
c) Depending on the
level of violation, Drug Administration of Vietnam - the Ministry of Health
shall send the medicine manufacturer and the medicine supplier an Official
Dispatch and stop receiving/considering the application for registration of
medicine or the application for registration of operation involving medicines
and medicine ingredients in Vietnam of a foreign company.
Apart from such form,
Drug Administration of Vietnam - the Ministry of Health will post the contents
of violation of the establishment on the website of the Ministry of Health;
report to the inspection agency, customs authority and functional agencies that
are competent to consider and handle according to the law.
2. Any agencies,
organizations, and individuals committing violations shall be imposed
suspension of receipt/consideration of application for export/import of
medicines or be administratively sanctioned or face criminal prosecution
depending on level of violations.
Chapter
VI
IMPLEMENTARY CLAUSE
Article
25. Effect
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Difficulties that
arise during the implementation of this Circular should be reported to the Drug
administration of Vietnam - the Ministry of Health for consideration and
solution./.
VERIFIED BY
PP. THE MINISTER
THE DEPUTY MINISTER
Pham Le Tuan
LIST
MEDICINE INGREDIENTS AND
FINISHED MEDICINES BANNED FROM IMPORT FOR PRODUCING MEDICINES FOR HUMAN
(Enclosed with Circular No. 47/2010/TT-BYT dated December 12th
2010 by the Minister of Health)
No.
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Scientific name
1
(+) - Lysergide(LSD, LSD-25)
9,10-didehydro-N,N-diethyl-6-methylergoline-8b-carboxamide
2
1-Phenyl-2-propanone
1-phenyl-2-propanone;
3
2C-B
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4
3,4-Methylenedioxyphenyl-2-propanone
(2-propanone,1-[3,4(methylenedioxy)phenyl]-);
5
3-methylfentanyl
N-(3-methyl-1-phenethyl-4-piperidyl)propionanilide
6
3-methylthiofentanyl
N-[3-methyl-1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide
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4-methylaminorex
(+)-cis-2-amino-4-methyl-5-phenyl-2-oxazoline
8
4-MTA
α-methyl-4-methylthiophenethlamine
9
Acetic anhydride
acetic oxide
10
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2-propanone
11
Acetorphine
3-O-acetyltetrahydro-7α-(1-hydroxy-1-methylbutyl)-6,14-endo-ethenooripavine
12
Acetyl-alpha-methylfentanyl
N-[1 α
-methylphenethyl)-4-piperidyl]acetanilide
13
Acetylmethadol
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14
Alphacetylmethadol
α-3-acetoxy-6-dimethylamino-4,4-diphenylheptane
15
Alphameprodine
α-3-ethyl-1-methyl-4-phenyl-4-propionoxypiperidine
16
Alphamethadol
α-6-dimethylamino-4,4-diphenyl-3-heptanol
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Alpha-methylfentanyl
N-[1-( α-methylphenethyl)-4-piperidyl]propionanilide
18
Alpha-methylthiofentanyl
N-[1-[1-methyl-2-(2-thienyl)ethyl]-4-piperidyl]propionanilide
19
Alphaprodine
α-1,3-dimethyl-4-phenyl-4-propionoxypiperidine
20
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(+)-α-methylphenethylamine
21
Amineptine
7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic
acid
22
Ampletamine
23
Analgin (metamizol;
Dipyrone)
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24
Anileridine
4-Piperidinecarboxylic
acid, 1--[2-(4-aminophenyl)ethyl]-4-phenyl-, ethyl ester
25
Anthranilic acid
2-aminobenzoic acid;
26
Aprotinin
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Astemizole
1-[(4-fluorophenyl)methyl]-N-[1-[2-(4-methoxyphenyl)ethyl]-4-piperidyl]-benzoimidazol-2-amine
28
Benzaldehyde
Benzoic Aldehyde; Benzenecarbonal
29
Benzethidine
1-(2-benzyloxyethyl)-4-phenylpiperidine-4-carboxylic
acid ethyl esterBenzylmorphine 3-benzylmorphine
30
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2-Phenylacetonenitrile
31
Betacetylmethadol
β-3-acetoxy-6-dimethylamino-4,4-diphenylheptane
32
Beta-hydroxy-3-methylfentanyl
N-[1-(β--hydroxyphenethyl)-3-methyl-4-piperidyl]propionanilide
33
Beta-hydroxyfentanyl
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34
Betameprodine
β-3-ethyl-1-methyl-4-phenyl-4-propionoxypiperidine
35
Betamethadol
β-6-dimethylamino-4,4-diphenyl-3-heptanol
36
Betaprodine
β-1,3-dimethyl-4-phenyl-4-propionoxypiperidine
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Brolamfetamine (DOB)
(+)-4-bromo-2,5-dimethoxy-α-methylphenethylamine
38
Cannabis and Cannabis resin
Cây cần sa và các sản phẩm chiết xuất từ
cây cần sa
39
Cathinone
(-)-(S)-2-aminopropiophenone
40
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acide
(6E)-(3R,5S)-7-[4-(4-fluorophényl)-5-(méthoxyméthyl)-2,6-bis(1-méthyléthyl)-3-pyridyl]-3,5-dihydroxyhept-6-énoïque
41
Chlormezanone
42
Clonitazene
2-(p-chlorobenzyl)-1-diethylaminoethyl-5-nitrobenzimidazole
43
Coca leaf
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44
Codoxime
dihydrocodeinone-6-carboxymethyloxime
45
CYCLOBARBITAL
5-(1-cyclohexen-1-yl)-5-ethylbarbituric
acid
46
Desomorphine
dihydrodeoxymorphine
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Desomorphine
dihydrodeoxymorphine
48
DET
3-[2-(diethylamino)ethyl]indole
49
Dexamfetamine (Dexamphetamine)
(+)-α-methyphenethylamine
50
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51
Dextropropoxyphen
a- (+)- 4-
dimethylamino- 1,2- diphenyl- 3- methyl- 2 - butanol propionate
52
Diampromide
N-[2-(methylphenethylamino)propyl]propionanilide
53
Diethylamine
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54
Diethylthiambutene
3-diethylamino-1,1-di(2’-thienyl)-1-butene
55
Dihydroetorphine
7,8-dihydro-7 α-[1-(R)-hydroxy-1-methylbutyl]-6,14-endo-ethanotetrahydrooripavine
56
Dihydromorphine
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Dimenoxadol
2-dimethylaminoethyl-1-ethoxy-1,1-diphenylacetate
58
Dimepheptanol
6-dimethylamino-4,4-diphenyl-3-heptanol
59
Dimethylthiambutene
3-dimethylamino-1,1-di(2'-thienyl)-1-butene
60
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Ethyl-4-morpholino-2,2-diphenylbutyrate
61
DMA
(+)-2,5-dimethoxy-α-methylphenethylamine
62
DMHP
3-(1,2dimethylheptyl)-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran-1-o1
63
DMT
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64
DOET
(+)-4-ethyl-2,5-dimethoxy-α-phenethylamine
65
Dronabinol
(6αR,10αR)-6α,7,8,10α-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-o1
66
Ecgonine
its esters and derivatives which are
convertible to ecgonine and cocaine
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Erythromycine d¹ng muèi Estolate
68
Ethyl ether
1,1'-oxybis[ethane]
69
Ethylene Diacetate
1,1-Ethanediol Diacetate
70
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3-ethylmethylamino-1,1-di(2’-thienyl)-1-butene
71
Eticyclidine (PCE)
N-ethyl-1-phenylcyclohexylamine
72
Etonitazene
1-diethylaminoethyl-2-p-ethoxybenzyl-5-nitrobenzimidazole
73
Etorphine
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74
Etoxeridine
1-[2-(2-hydroxyethoxy)ethyl]-4-phenylpiperidine-4-carboxylic
acid ethyl ester
75
Etryptamine
3-(2-aminobutyl)indole
76
Fenetylline
7-[2-[(α-methylphenethyl)amino]ethyl]-theophylline
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Fenfluramine
78
Formamide
Methanamide; Carbamaldehyde
79
Furethidine
1-(2-tetrahydrofurfuryloxyethyl)-4-phenylpiperidine-4-carboxylic
acid ethyl ester
80
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81
GHB
γ-hydroxybutyric acid
82
Glafenine
83
Heroin
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84
Hydrocodone
Dihydrocodeinone
85
Hydromorphinol
14-hydroxydihydromorphine
86
Hydroxypethidine
4-m-hydroxyphenyl-1-methylpiperidine-4-carboxylic
acid ethyl ester
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Isomethadone
6-dimethylamino-5-methyl-4,4-diphenyl-3-hexanone
88
Isosafrole
(1,3-benzodioxole,5-(1-propenyl)-)
89
Ketobemidone
4-m-hydroxyphenyl-1-methyl-4-propionylpiperidine
90
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(-)-(R)-α-methylphenethylamin
91
Levamisole
(6S)-2,3,5,6-Tetrahydro-6-phenylimidazo
[2,1-b] thiazole
92
Levomethamphetamine
(-)-N,α-dimethylphenethylamine
93
Levomethorphan*
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94
Levomoramide
(-)-4-[2-methyl-4-oxo-3,3-diphenyl-4-(1-pyrrolidinyl)butyl]morpholine
95
Levophenacylmorphan
(-)-3-hydroxy-N-phenacylmorphinan
96
Lysergic acid
((8ß)-9,10-didehydro-6-methylergoline-8-carboxylic;
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MDE, N-ethyl MDA
(+)-N-ethyl-α-methyl-3,4-(methylenedioxy)phenethylamine
98
MDMA
(+)-N,α-dimethyl-3,4-(methylene-dioxy) phenethylamine
99
Mecloqualone
3-(o-chlorophenyl)-2-methyl-4(3H)-quinazolinone
100
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3,4,5-trimethoxyphenethylamine
101
Mescathinone
2-(methylamino)-1-phenylpropan-1-one
102
Metamfetamine (Metamphetamine)
(+)-(S)-N,α-dimethylphenethylamine
103
Metamfetamine racemate
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104
Metazocine
2'-hydroxy-2,5,9-trimethyl-6,7-benzomorphan
105
Methadone intermediate
4-cyano-2-dimethylamino-4,4-diphenylbutane
106
Methaqualone
2-methyl-3-o-tolyl-4(3H)-quinazolinone
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Methyl ethyl ketone
2-butanone
108
Methylamine
Monomethylamine; Aminomethane
109
Methyldesorphine
6-methyl-.6-deoxymorphine
110
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6-methyldihydromorphine
111
Metopon
5-methyldihydromorphinone
112
MMDA
5-methoxy-α-methyl-3,4-(methylenedioxy)phenethylamine
113
Moramide intermediate
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114
Morpheridine
1-(2-morpholinoethyl)-4-phenylpiperidine-4-carboxylic
acid ethyl ester
115
MPPP
1-methyl-4-phenyl-4-piperidinol propionate
(ester)
116
N-Acetylanthranilic acid
benzoic acid, 2-(acetylamino)-
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N-hydroxy MDA
(+)-N-[α-methyl-3,4-(methylenedioxy)
phenethyl]hydroxylamine
118
Nimesulide (trừ thuốc
thành phẩm dạng dùng ngoài da, nguyên liệu dể sản xuất thuốc dùng ngoài da)
119
Nitroethane
120
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121
Noracymethadol
(±.)-α-3-acetoxy-6-methylamino-4,4-diphenylheptane
122
Norlevorphanol
(-)-3-hydroxymorphinan
123
Normethadone
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124
Normorphine
Demethylmorphine
125
Norpipanone
4,4-diphenyl-6-piperidino-3-hexanone
126
Para-fluorofentanyl
4'-fluoro-N-(1-phenethyl-4-piperidyl)propionanilide
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Parahexyl
3-hexyl-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]
pyran-1-o1
128
PEMOLINE
2-amino-5-phenyl-2-oxazolin-4-one
129
PEPAP
1-phenethyl-4-phenyl-4-piperidinol acetate
(ester)
130
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4-cyano-1-methyl-4-phenylpiperidine
131
Pethidine intermediate B
4-phenylpiperidine-4-carboxylic acid ethyl
ester
132
Pethidine intermediate C
1-methyl-4-phenylpiperidine-4-carboxylic
acid
133
Phenacetine
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134
Phenadoxone
6-morpholino-4,4-diphenyl-3-heptanone
135
Phenampromide
N-(1-methyl-2-piperidinoethyl)propionanilide
136
Phencyclidine (PCP)
1-(1-phenylcyclohexyl)piperidine
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Phenmetrazine
3-methyl-2-phenylmorpholine
138
Phenolphtalein
3,3-bis
(4-hydroxyphenyl)-1-(3H)-isobenzofuranone
139
Phenomorphan
3-hydroxy-N-phenethylmorphinan
140
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1-(3-hydroxy-3-phenylpropyl)-4-phenylpiperidine-4-carboxylic
acid ethyl ester
141
Phenylacetic acid
benzeneacetic acid
142
Phenylpropanolamin
(Norephedrin)
Benzenemethanol,
a - (1- aminoethyl)- (+)-
143
Piminodine
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144
Piperidine
Piperidine
145
Piperonal
1,3-benzodioxole-5-carboxaldehyde;
146
Piperonyl Methyl Cetone
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PIPRADROL
1,1-diphenyl-1-(2-piperidyl)methanol
148
Piritramide
1-(3-cyano-3,3-diphenylpropyl)-4-(1-piperidino)piperidine-4-carboxylic
acid amide
149
PMA
p-methoxy-α-methylphenethylamine
150
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151
Proheptazine
1,3-dimethyl-4-phenyl-4-propionoxyazacycloheptane
152
Properidine
1-methyl-4-phenylpiperidine-4-carboxylic
acid isopropyl ester
153
Psilocine, psilotsin
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154
Psilocybine
3-[2-(dimethylamino)ethyl]indole-4-yl
dihydrogen phosphate
155
Pyramidon (Aminophenazone)
4-diméthylamino-2,3-diméthyl-1-phényl-3-pyrazolin-5-one
156
Racemethorphan
(±)-3-methoxy-N-methylmorphinan
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Racemoramide
(±)-4-[2-methyl-4-oxo-3,3-diphenyl-4-(1-pyrrolidinyl)butyl]morpholine
158
Racemorphan
(±)-3-hydroxy-N-methylmorphinan
159
Remifentanil
1-(2-methoxy carbonylethyl)-4-(phenylpropionylamino)piperidine-4-carboxylic
acid methyl ester
160
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1-(1-phenylcyclohexyl)pyrrolidine
161
Safrole
(1,3-benzodioxole,5-(2-propenyl)-);
HS code: 2932.94 CAS number: 94-59-7
162
Santonin
[3s-(3 α, 3aα, 5aβ, 9bβ]-3a,5,5a,9b -
Tetrahydro - 3 5a, 9 - trimethylnaphtho [1,2-b] furan-2, 8 (3H,4H)- dione
163
Secobarbital
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164
Sibutramine
(±)-dimethyl-1-[1-(4-
chlorophenyl) cyclobutyl]-N,N,3-trimethylbutan- 1-amine
165
STP, DOM
2,5-dimethoxy-α,4-dimethylphenethylamine
166
Sulphuric acid 1
sulfuric acid
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Tenamfetamine (MDA)
α-methyl-3,4-(methylenedioxy)
phenethylamine
168
Tenocyclidine (TCP)
1-[1-(2-thienyl)cyclohexyl]piperidine
169
Terfenadine
170
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7,8,9,10-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]
pyran-1-o1;
(9R,10αR)-8,9,10,10α-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-o1;
(6αR,9R,10αR)-6α,9,10,10α-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-o1;
(6αR,10αR)-6α,7,10,10α-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-o1;
6α,7,8,9-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-o1;
(6αR,10αR)-6α,7,8,9,10,10a-hexahydro-6,6,dimethyl-9-methylene-3-pentyl-6H-dibenzo[b,d]pyran-1-o1
171
Thebaine
6,7,8,14-Tetradehydro-4,5-epoxy-3,6-dimethoxy-17-methylmorphinan;
paramorphine
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Thiofentanyl
N-[1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide
173
Tilidine
(±)-ethyl-trans-2-(dimethylamino)-1-phenyl-3-cyclohexene-1-carboxylate
174
TMA
(+)-3,4,5-trimethoxy-α-methylphenethylamine
175
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benzene, methyl-
176
Trimeperidine
1,2,5-trimethyl-4-phenyl-4-propionoxypiperidine
177
Ziperol
α-(α-methoxybenzy)-4-(β-methoxyphenethyl)-1-piperazineethanol
178
Zomepirac
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