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MINISTRY OF
HEALTH
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SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
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No. 03/2016/TT-BYT
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Hanoi, January
21, 2016
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CIRCULAR
HERBAL
INGREDIENT TRADING
Pursuant to the Law on Pharmacy No. 34/2005/QH11
dated June 14, 2005;
Pursuant to the Government's Decree No.
79/2006/ND-CP dated August 09, 2006, specifying the implementation of a number
of articles of the Law on Pharmacy and the Government's Decree No.
89/2012/ND-CP dated October 24, 2012 on amendments to Decree No. 79/2006/ND-CP;
Pursuant to the Government's Decree No.
63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and
organizational structure of the Ministry of Health;
At the request of Director of Traditional Medicine
Administration of Vietnam,
The Minister of Health promulgates a Circular on
herbal ingredient trading.
Chapter I
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Article 1. Scope
This Circular provides for herbal ingredient
trading, including export, import, wholesaling, retailing of herbal
ingredients, and herbal ingredient preservation services.
Article 2. Regulated entities
1. This Circular applies to enterprises,
cooperatives, households and individuals (hereinafter referred to as
facilities) engaged in herbal ingredient trading and herbal ingredient trading
authorities in Vietnam.
2. This Circular does not apply to:
a) Facilities trading in raw herbal ingredients,
herbal ingredients not used for medicines according to invoices and documents;
b) Medical facilities concocting medicines
(commercial drugs, traditional ingredients) for internal use.
Article 3. Definitions
For the purpose of this Circular, the terms below
are construed as follows:
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2. Herbal ingredients are natural materials
derived from plants, animals, minerals that satisfy standards for medicine
ingredients of Vietnam's pharmacopoeia.
3. Toxic herbal ingredients are herbal
ingredients on the list of toxic herbal ingredients in Vietnam compiled by the
Minister of Health.
4. Traditional remedies are raw herbal
ingredients, prepared herbal ingredients, or processed herbal ingredients that
can be used for preparing medicines.
5. Preparation means inspection and
classification of provider of taxation services, removal of impurities,
immersion, incubation, washing, drying, cleaning, drying, cutting, or grinding.
6. Processing means the process that results
in qualitative and quantitative changes of raw herbal ingredients or prepared
herbal ingredients into traditional remedies according to principles and
methods of traditional medicine.
Chapter II
EXPORT, IMPORT,
WHOLESALING, RETAILING OF HERBAL INGREDIENTS, AND HERBAL INGREDIENT
PRESERVATION SERVICES
Article 4. General conditions
applied to facilities exporting, importing, wholesaling, retailing herbal
ingredients, or providing herbal ingredient preservation services
1. Every facility exporting, importing, wholesaling,
retailing herbal ingredients, or providing herbal ingredient preservation
services must obtain a Certificate of Eligibility for Drug Business that covers
herbal ingredient trading.
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a) The technical manager of the facility has a
pharmaceutical practice certificate as prescribed in Article 15 of Decree No.
79/2006/ND-CP, except for the cases specified in Article 11 of this Circular.
If a business location of a facility has various
forms of drug business, only one of the technical manager has to satisfy the
condition specified herein.
b) The facility satisfy conditions corresponding to
its form of business as prescribed in Article 5 through 8 of this Circular.
Article 5. Export and import of
herbal ingredients
1. A Vietnamese facility importing herbal
ingredients must satisfy the following conditions:
a) It has been granted the Certificate of
Eligibility for Drug Business that covers herbal ingredient trading.
b) Good Storage Practice (GSP) applied to herbal
ingredients are implemented in accordance with this Circular according to
inspection result given by the Ministry of Health.
c) A facility that has not fulfilled import
conditions shall enter into an import entrustment contract with another
facility that satisfies import conditions and the name of the entrusting
facility must be written on the import bill.
2. Apart from the conditions specified in Clause 1
of this Article, upon registration of the customs declaration, the importer
must present the originals and submit the copies bearing the importer's seal of
the following documents to the customs authority:
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b) Certificate of Origin (C/O) of the herbal
ingredients issued by a competent authority of the exporting country. Where an
international agreement to which Vietnam is a signatory permits the submission
of electronic C/Os, the customs authority shall accept such electronic C/Os.
c) From July 01, 2016, each shipment of imported
herbal ingredients on the List must have a test result notice (enclosed with an
English or Vietnamese translation) of the manufacturer which implements GMP. A
manufacturer that does not apply GMP shall have a test result notice issued by
a competent authority of the exporting country. Annually, the Ministry of
Health shall publish the List of herbal ingredients requiring presentation of
test result notice issued by competent authorities of the exporting countries.
3. A Vietnamese facility exporting herbal
ingredients must satisfy the following conditions:
a) The conditions specified in Point a Clause 1 of
this Article.
b) The conditions imposed by the importing
countries (if any).
Article 6. Conditions applied
to facilities herbal ingredient wholesalers
1. GSP applied to herbal ingredients specified in
Article 9 and Good Distribution Practice applied to herbal ingredients
specified in Article 10 of this Circular are implemented.
2. Every facility granted the Certificate of
Eligibility for Drug Business that covers herbal ingredient wholesaling may
also provide herbal ingredient preservation services without having to follow
procedures for expansion of operating scope.
Article 7. Conditions applied
to herbal ingredient retailers
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a) There is a fixed and isolated location with an
area of at least 25 m2 suitable for the scope of business. The
location must be dry, airy, safe, away from pollution sources, ensure fire
safety; herbal ingredients are displayed and preserved in separated areas.
b) There are adequate preserving
equipment for protecting medicines from negative impacts of light, temperature,
humidity, pollution, insects, including:
- Shelves, counters, racks that are sturdy, smooth,
easy to clean, convenient for displaying and preserving medicines.
- Thermometers, hygrometer, dehumidifier for
temperature and humidity control at the facility, lighting and ventilation system.
- The preserving equipment must satisfy
preservation conditions written on the label. Temperature must be maintained at
below 30°C, humidity not exceeding 75%.
2. Personnel:
a) There are adequate workers whose qualifications
are suitable for their jobs, one of which must have a pharmacist assistance's
qualification.
b) All workers are provided with regular training
in professional knowledge and new regulations on preservation and management of
herbal ingredients.
3. Retailers may only sell herbal ingredients that
are purchased from facilities satisfying conditions for trading in herbal
ingredients, have clear origins, packages, labels that comply with provisions
of Clause 1 Section B Part II of Circular No. 04/2008/TT-BYT on drug labeling;
may not sell unprocessed toxic herbal ingredients as prescribed in Circular No.
33/2012/TT-BYT dated December 28, 2012 of the Minister of Health.
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Every provider of herbal ingredient preservation
services must implement GSP applied to herbal ingredients as prescribed in
Article 9 of this Circular.
Article 9. "Good storage
practice" (GSP) applied to herbal ingredients
1. Personnel of the warehouse:
a) The warehouse keeper must have an associate
degree in pharmacy or above.
b) There are adequate workers whose qualifications
are suitable for their jobs, one of which has a pharmacist assistance's
qualification or above.
c) All workers are provided with regular training
in professional knowledge and new regulations on preservation and management of
herbal ingredients.
2. Location of the warehouse:
a) The warehouse is built at a dry, airy and safe
place, has a drainage system , and ensures that herbal ingredients are
protected from underground water, heavy rain, and flood.
b) The warehouse has a fixed address and its
location is convenient for delivery of herbal ingredients.
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a) The warehouse must have a sufficient area which
is suitable for the scope of business in order to preserve various products
orderly. The minimum area is 300 m2, the minimum volume in 1,000 m3. From
January 01, 2016, the minimum area is 500 m2 and minimum volume 1,500 m3 (only
applied during re-inspection if a GSP certificate is already obtained),
including: reception area, area for storage of raw herbal ingredients, area for
storage of processed herbal ingredients; intermediate storage area; and area
for storage of toxic herbal ingredients.
b) The intermediate storage area and the area for
storage of raw herbal ingredients must be isolated from other areas in order to
avoid cross-contamination and dust.
c) Storage areas must be able to prevent insects,
rodents, and other animals; prevent the development of molds and fungi,
termites, and cross-contamination.
d) The ceiling, walls, and roof of the warehouse
must be sturdy, airy, and able to withstand weather impacts such as sunlight,
rain, storm, flood.
dd) The ground of the warehouse must be adequately
elevated, flat, smooth, and hard, and able to withstand the impact of
underground water, ensure that vehicles can easily move, and not have cracks
which are places for dust and insects.
4. Sanitary equipment shall comply with
requirements specified in Section 2.3, Section 3 Part 2 of the Appendix
enclosed with Decision No. 2701/2001/QD-BYT dated June 29, 2011 on application
of GSP.
5. Storage procedures and documents:
Storage procedures and documents shall comply with
instructions in Section 4, Section 7 Part II of GSP enclosed with Decision No.
2701/2001/QD-BYT.
6. The power to inspect implementation of GSP:
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b) Services of Health of provinces shall carry out
inspection of implementation of GSP by herbal ingredient warehouses of other
facilities trading in herbal ingredients other than those specified in Point a
of this Clause.
Article 10. "Good
distribution practice" (GDP) applied to herbal ingredients
GDP applied to herbal ingredients are specified in
Circular No. 48/2011/TT-BYT dated December 21, 2011 of the Minister of Health;
Clause 2 through 4 Article 9 of this Circular shall apply to herbal ingredient
storage.
Article 11. Trading herbal
ingredients in trade villages and herbal ingredient neighborhoods
1. The export, import, wholesaling of herbal
ingredients, and provision of herbal ingredient preservation services in trade
villages and herbal ingredient neighborhoods must comply with corresponding
regulations in Article 4, 5, 6, and 8 of this Circular.
2. The retailing of herbal ingredients in trade
villages and herbal ingredient neighborhoods must comply with regulations in
Article 7 of this Circular. The person in charge or owner of herbal ingredient
retailing outlets in trade villages and herbal ingredient neighborhoods must
have the qualifications specified in Point c Clause 3 Article 15 of Decree No.
79/2006/ND-CP or certificates of training in traditional medicine or pharmacy
issued by competent training organizations.
Chapter III
PROCESSING HERBAL
INGREDIENTS
Article 12. Conditions for
processing herbal ingredients
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At least 30 days before the commencement of herbal
ingredient processing, the facility shall submit a notice of fulfillment of
conditions for processing herbal ingredients (the form in Appendix 07 enclosed
herewith) of Traditional Medicine Administration of Vietnam - the Ministry of
Health.
2. The Ministry of Health shall inspect the fulfillment
of conditions for processing herbal ingredients every 3 years and carry out
surprise inspection where necessary.
Article 13. Personnel
1. The person in charge of the processing facility
must have at least a bachelor's degree in pharmacy and a pharmaceutical
practice certificate as prescribed by law.
2. The persons participating in herbal ingredient
processing must have at least pharmacist assistant qualifications and regularly
receive training in herbal ingredient processing.
Article 14. Infrastructure
1. The building and equipment must be designed,
built, repaired, and maintained in a way that is appropriate for the production
works and the scale of the facility. To be specific:
a) The area for storage of raw herbal ingredients
must satisfy the conditions specified in Clause 2 and 3 Article 9 of this
Circular.
b) Production and processing areas:
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The preparation area is where raw materials are
cleaned, cut, dried. The minimum area is 9 m2 and minimum volume is
27 m3.
The deep processing area is where raw materials are
processed, drenched, The minimum area is 9 m2 and minimum volume is
27 m3.
The production area must be adequately large, airy,
easy to clean, safe for production, convenient for work, and have a clean water
supply system serving herbal ingredient production.
c) Quality inspection area:
The area where raw materials and finished products
undergo quality inspection must be separate from the production area. The
design of the quality inspection area must be appropriate for inspection tasks.
2. Auxiliary systems:
a) Air treatment system:
Each area must have a separate air treatment system
or air conditioning system.
b) Water treatment system:
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c) Wastewater, exhaust, and solid waste treatment
systems:
The processing facility must take appropriate
measures for treating wastewater, exhaust, and solid wastes in order to ensure
safety and hygiene.
d) Fire safety system:
The processing facility must have adequate fire
safety and firefighting equipment according to regulations of law on fire
safety.
Article 15. Equipment
1. The processing facility must have adequate
equipment serving herbal ingredient processing. Such equipment must be safe for
operation, easy to clean and maintain, able to prevent cross-contamination,
accumulation of dust and dirt, and negative impacts on product quality. The
processing facility must establish and comply with instructions on operating
and cleaning equipment.
2. The quality inspection area must have devices
and equipment suitable for sampling, analysis, calibration, and data
processing. Analysis equipment must be suitable for the testing method and satisfy
quality inspection requirements of the facility.
Article 16. Quality of herbal
ingredients during processing
Herbal ingredients used for processing must undergo
quality inspection according to the standards of Vietnam's pharmacopoeia
specified in Circular No. 09/2010/TT-BYT dated April 28, 2010 of the Minister
of Health on medicine quality management. The facility must keep a log of the
quality of herbal ingredients purchased, sold, and unused.
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1. Weighing and dispensing:
Before herbal ingredients are weighed and
dispensed, the its is required to check environmental conditions in terms of
hygiene, temperature, and humidity of such area; herbal ingredients must be
weighed and dispensed accurately. Workers must wear protective clothing in
accordance with regulations of law on occupational hygiene and safety.
2. Processing:
a) The quantity of workers must be adequate;
workers must wear clothing suitable for processing tasks and measures are taken
to supervise processing tasks.
b) All pieces of equipment must be checked before
use. Weighing and measuring equipment must be calibrated and the deviation of
which must be suitable for the raw materials being measured.
c) It is required to have a processing procedures
applied to each type of herbal ingredient according to the herbal ingredient
processing methods prescribed by the Ministry of Health in Decision No.
3759/QD-BYT dated October 08, 2010 and Decision No. 3635/QD-BYT dated September
16, 2014.
3. Control during processing:
a) It is required to establish procedures for
controlling quality of intermediary products and finished products.
b) All inspection results during the processing and
environment control must be recorded.
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a) The area for packaging and area for labeling
must be separated from one another to avoid confusion between products and
packages.
b) Every label and package design that is used must
be kept together with the batch records.
Article 18. Preservation of
finished products
Finished products (processed herbal ingredients)
must be preserved in the finished product warehouse which satisfies all
conditions specified in Clause 2 and Clause 3 Article 9 hereof. The minimum
area of the finished product warehouse is 200m2, minimum volume 600 m3.
Article 19. Hygiene
The processing facility must apply facility hygiene
and personal hygiene principle throughout the processing of herbal ingredients,
including hygiene of the building, personal hygiene, hygiene of machinery,
equipment and packages. Hygienic requirements and hygiene conditions specified
in Article 6 of Circular No. 16/2011/TT-BYT dated April 19, 2011 of the
Minister of Health on rules for manufacturing of herbal medicines and roadmap
for applying GMP to manufacturers of herbal medicines.
Article 20. Processing records
1. The records of each processing batch must
specify: name and quantity of products; processing date, batch number, full
formula of the batch; standard operating procedures (SOPs) of each stage;
standard operating procedure for operating and cleaning primary equipment; all
samples and inspection results obtained during the processing, result of
environmental condition inspection and equipment inspection before and during
the processing, packaging, and labeling on the final packages.
2. It is required to have records on every raw
materials and additives used, SOPs, each batch and shipment; equipment
including operation, cleaning, maintenance, and inspection; records on cleaning
works, maintenance, and environment control of the processing area.
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Chapter IV
JURISDICTION,
APPLICATION, PROCEDURES FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR DRUG
BUSINESS COVERING HERBAL INGREDIENT TRADING, LICENSES FOR EXPORT, IMPORT OF
HERBAL INGREDIENTS
Section 1. JURISDICTION,
APPLICATION, PROCEDURES FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR DRUG
BUSINESS COVERING HERBAL INGREDIENT TRADING
Article 21. The power to
issue, reissue, renew Certificate of Eligibility for Drug Business, and expand
business scope thereof
1. The Ministry of Health has the power to issue,
reissue, renew Certificate of Eligibility for Drug Business to providers of herbal
ingredient preservation services.
2. Services of Health have the power to issue,
reissue, renew, and expand Certificate of Eligibility for Drug Business of
facilities trading in herbal ingredients other than those specified in Clause 1
of this Article.
Article 22. Applications for
issuance, reissuance, renewal, expansion of Certificate of Eligibility for Drug
Business submitted by providers of herbal ingredient preservation services,
herbal ingredient wholesalers and retailers
1. The composition of an application for issuance,
reissuance, renewal, expansion of Certificate of Eligibility for Drug Business
submitted by a provider of herbal ingredient preservation services, herbal
ingredient wholesaler or retailer is specified in Clause 6 Article 1 of Decree
No. 89/2012/ND-CP. The document forms are provided in Appendix 01a, 01b,
01c, 01d enclosed herewith.
2. Technical documents mentioned in Point c Clause
6 Article 1 of Decree No. 89/2012/ND-CP include:
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- A diagram of location and design of the
warehouse;
- List of preservation equipment of the facility
and goods preserved in the warehouse.
b) For wholesalers:
- Documents about herbal ingredient storage: A
diagram of location and design of the warehouse, List of preservation equipment
of the facility and the goods preserved in the warehouse.
- Documents about herbal ingredient distribution: A
diagram of the facility's organizational structure including the distribution
system (headquarters, branches, warehouses, agents). The diagram must specify
the names, positions, qualifications of managers of the facility and its
departments; List of vehicles. If herbal ingredients are transported under a
contract, it is required to have documents about the contractor's identity,
preservation equipment, and vehicles.
- List of personnel (the form in Appendix 02
enclosed herewith).
c) For retailers:
- A diagram of location and design of areas where
herbal ingredients are displayed and stored.
- List of personnel (the form in Appendix 02
enclosed herewith).
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Article 23. Procedures for
issuance of Certificate of Eligibility for Drug Business to a provider of
herbal ingredient preservation services
1. A provider of herbal ingredient preservation
services shall submit 01 application for issuance, reissuance, renewal, or
expansion of the Certificate of Eligibility for Drug Business specified in
Article 22 of this Circular to Traditional Medicine Administration of Vietnam
- Ministry of Health.
2. After receiving the application, the receiving
body shall issue a note of receipt (the form provided in Appendix 03 enclosed
herewith).
3. If the application is not satisfactory, within
10 working days from the day on which it is received, the receiving body must
request the applicant to complete the application.
4. Within 10 working days from the day on which the
satisfactory application is received, Traditional Medicine Administration of
Vietnam shall establish an inspectorate to verify the application, carry out an
inspection at the facility providing herbal ingredient preservation services,
and issue an inspection record.
5. Within 10 working days after the inspection
record is issued, Director of Traditional Medicine Administration of Vietnam
shall issue, reissue, renew, or expand the Certificate of Eligibility for Drug
Business. If the application is rejected, Traditional Medicine Administration
of Vietnam shall provide explanation in writing.
Article 24. Procedures for issuance
of Certificate of Eligibility for Drug Business to wholesaler or retailer of
herbal ingredients
1. A wholesaler or retailer of herbal ingredients
shall submit 01 application for issuance, reissuance, renewal, or expansion of
the Certificate of Eligibility for Drug Business specified in Article 22 of
this Circular to the Service of Health of the province where their headquarters
are located.
2. After receiving the application, the receiving
body shall issue a note of receipt (the form provided in Appendix 03 enclosed
herewith).
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4. Within 10 working days from the day on which the
satisfactory application is received, the Service of Health shall establish an
inspectorate to verify the application, carry out an inspection at the
facility, and issue an inspection record.
5. Within 10 working days after the inspection
record is issued, Director of the Service of Health shall issue, reissue,
renew, or expand the Certificate of Eligibility for Drug Business. If the
application is rejected, the Service of Health shall provide explanation in
writing.
Section 2. JURISDICTION,
APPLICATION, PROCEDURES FOR ISSUANCE OF HERBAL INGREDIENT IMPORT LICENSE
Article 25. Application for
herbal ingredient import license
1. A list of imported goods (the form in Appendix
04 enclosed herewith). In case of import entrustment, the list must specify the
name of the entrusted party.
2. A quality standards and herbal ingredient
testing method of the manufacturer or photocopies of the quality standard
treatise of the pharmacopoeia.
3. If herbal ingredients contain addictive,
psychotropic ingredients or precursors, a stocktaking report (the form provided
in Appendix 05 enclosed herewith) must be enclosed with the application.
Article 26. Jurisdiction,
procedures for issuance of herbal ingredient import license
1. Director of Traditional Medicine Administration
of Vietnam - Ministry of Health has the power to issue herbal ingredient import
licenses.
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3. If the application is not satisfactory, within
10 working days from the day on which it is received, the receiving body must
request the applicant to complete the application.
4. Within 07 working days from the day on which the
satisfactory application is received, Traditional Medicine Administration of
Vietnam shall consider issuing the herbal ingredient import license (the form
provided in Appendix 06 enclosed herewith). If the application is rejected,
Traditional Medicine Administration of Vietnam shall provide explanation in
writing.
5. Each herbal ingredient import license is valid
for up to 01 year from its date of issue.
Chapter VI
EFFECT
Article 27. Effect
1. This Circular comes into force from March 06,
2016.
2. Regulations on export and import of herbal
ingredients in Circular No. 47/2010/TT-BYT dated December 29, 2010 on export,
import of medicines and primary packages thereof, Circular No. 38/2013/TT-BYT
dated November 15, 2013 of the Minister of Health on amendments to Circular No.
47/2010/TT-BYT.
Article 28. Transition
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2. If the GSP certificate or GDP certificate
expires before the expiration date of the Certificate of Eligibility for Drug
Business, instructions of this Circular shall apply to inspection serving the
reissuance of the Certificate of Eligibility for Drug Business.
3. Applications for the GSP certificate submitted
before the effective date of this Circular shall be processed in accordance
with Circular No. 45/2011/TT-BYT dated December 21, 2011 of the Minister of
Health.
4. Applications for the GDP certificate submitted
before the effective date of this Circular shall be processed in accordance
with Circular No. 48/2011/TT-BYT dated December 21, 2011 of the Minister of
Health.
Article 29. Reference clause
Where any document referred to in this Circular is
amended or replaced, the amending or replacing one shall apply.
Article 30. Responsibility for
implementation
1. Director of Traditional Medicine Administration
of Vietnam shall organize, inspect and assess the implementation of this
Circular nationwide.
2. Directors of Services of Health or provinces
shall organize, inspect and assess the implementation of this Circular within
their provinces.
Difficulties that arise during the implementation
of this Circular should be reported to Traditional Medicine Administration of
Vietnam - the Ministry of Health for consideration./.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
PP MINISTER
DEPUTY MINISTER
Pham Le Tuan
APPENDIX
01a
(Enclosed with Circular
No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
------------------
APPLICATION
for
Certificate of Eligibility for Drug Business
To: .............1...............
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Affiliated to (if any) …………………………………
Person in charge ………………………………………… Year of birth:
……………
Practice certificate No. : ………… Issuer: ……….
Year of issue: ……….. Expiration date (if any): …………..
Business address: ……………………………………. Tel: …………………………
We hereby requests the Ministry of Health/Service
of Health to issue the Certificate of Eligibility for Drug Business that covers
herbal ingredient trading to our facility with the following types and scope of
business:2 ………………….
Business address: …………………………………………………………………………
Tel …………………………………………………………………………………………..
After carefully studying the Law on Pharmacy and
other regulations on pharmaceutical practice, we commit ourselves to fully comply
with legislative documents and other relevant statutes on pharmacy as well as
strictly follow instructions of the Ministry of Health and Service of Health of
……………..
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
[Location and
date]
Director of enterprise/Facility owner
(Signature and full name)
_______________
1 Issuer of the Certificate of
Eligibility for Drug Business
2 Write the type of business
APPENDIX
01b
(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
------------------
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To: ………….1……………
Name of facility ……………………………………………………………………………
Affiliated to (if any) …………………………………
Person in charge ………………………………………… Year of birth:
……………
Practice certificate No. : ………… Issuer: ……….
Year of issue: ……….. Expiration date (if any): …………..
Business address: ……………………………………. Tel: …………………………
Issued Certificate of Eligibility for Drug Business
with the following scope: ……………………………………………………………………………………….
Requested addition:: ……………………………………………………………………………
Business location: ………………………………………………………………………………
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
After carefully studying the Law on Pharmacy and
other regulations on pharmaceutical practice, we commit ourselves to fully
comply with legislative documents and other relevant statutes on pharmacy as
well as strictly follow instructions of the Ministry of Health and Service of
Health of ……………..
[Location and
date]
Director of enterprise/Facility owner
(Signature and full name)
_______________
1 Issuer of the Certificate of
Eligibility for Drug Business
2 Specify the changed conditions
APPENDIX
01a
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
------------------
APPLICATION
for
Renewal of Certificate of Eligibility for Drug Business
To: ………….1……………
Name of facility ……………………………………………………………………………
Affiliated to (if any) …………………………………
Person in charge ………………………………………… Year of birth:
……………
Practice certificate No. : ………… Issuer: ……….
Year of issue: ……….. Expiration date (if any): …………..
Business address: ……………………………………. Tel: …………………………
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
We hereby requests the renewal of the Certificate
of Eligibility for Drug Business. Type of business:
……………………………………………………………………………………….
Scope of business:
…………………………………………………………………………………..
Business address:
After carefully studying the Law on Pharmacy and
other regulations on pharmaceutical practice, we commit ourselves to fully
comply with legislative documents and other relevant statutes on pharmacy as
well as strictly follow instructions of the Ministry of Health and Service of
Health of ……………..
[Location and
date]
Director of enterprise/Facility owner
(Signature and full name)
_______________
1 Issuer of the Certificate of
Eligibility for Drug Business
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPENDIX
01a
(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
------------------
APPLICATION
for
Reissuance of Certificate of Eligibility for Drug Business
To: ………….1……………
Name of facility ……………………………………………………………………………………
Affiliated to (if any) …………………………………
Person in charge ………………………………………… Year of birth:
……………
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Business location: …………………………………………………………………………………
Type of business: ………………………………………………………………………………….
Scope of business: …………………………………………………………………………………
We hereby requests ………………. to reissue the
Certificate of Eligibility for Drug Business to:
Name of facility ……………………………………………………………………………
Affiliated to (if any) …………………………………
Business address: ……………………………………. Tel: …………………………
Person in charge ………………………………………… Year of birth:
……………
Practice certificate No. : ………… Issuer: ……….
Year of issue: ……….. Expiration date (if any): …………..
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Scope of business: …………………………………………………………………………….
Reason for reissuance:2
………………………………………………………………………
……………………………………………………………………………………………………
After carefully studying the Law on Pharmacy and
other regulations on pharmaceutical practice, we commit ourselves to fully
comply with legislative documents and other relevant statutes on pharmacy as
well as strictly follow instructions of the Ministry of Health and Service of
Health of ……………..
[Location and
date]
Director of enterprise/Facility owner
(Signature and full name)
_______________
1 Issuer of the Certificate of
Eligibility for Drug Business
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPENDIX
02
(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
NAME OF
FACILITY
-------
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
------------------
LIST OF PERSONNEL
Facility: …………………………………………………………………………………..
Owner: …………………………………….. Practice certificate No.:
…………………………
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Scope of business:
No.
Full name
Year of birth
Permanent
residence
Qualification
Year of
graduation
Qualification
issuer
Tasks
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Female
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
....[location and
date]
FACILITY OWNER
(signature and full name)
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(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
…….1……
-------
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
------------------
No.
/PTN-....2…..
[location 3 and
date]
NOTE OF RECEIPT
of
Application for
issuance, reissuance, renewal, changes of
Certificate of Eligibility for Drug Business
Receiving body:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Received the application from Mr./Ms.:
………………………………………………
ID/passport No. :
Date of issue: …………….
Issuer: ……..
Tel ………………………………………………………………………………………….. ;
Representative of:
Request:
Issuance of new Certificate: □
Reissuance: □
Renewal: □
Changes of scope: □
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Scope of business:
The application consists of:
1. Original copy of the practising certificate □
2. Certificate of Business Registration/Certificate
of Investment
3. Technical documents
□
4. Agent contract
□
Appointment date:
………………………………………………………………………………
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Additional documents:
Additional documents:
Additional documents:
Date:
Date:
Date:
Signature
Signature
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_______________
1 Name of the issuer of the practising
certificate
2 Abbreviated name of the issuer of the
practising certificate
3 Location
APPENDIX
04
(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
NAME OF
IMPORTER
No. ………….
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
LIST OF IMPORTED HERBAL
INGREDIENTS
To: Traditional
Medicine Administration of Vietnam - Ministry of Health
……… (name of importer).... hereby requests
Traditional Medicine Administration of Vietnam - Ministry of Health to permit
the import of the following herbal ingredients for ……. (specify the purposes):
No.
Vietnamese name of
enterprise, used parts
Scientific name
(Latin name)
Unit
Quantity
...
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Origin (country)
Name of supplier,
country
Notes
1
...
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2
...
...
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3
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Traditional
Medicine Administration of Vietnam
hereby accepts the
list of imported herbal ingredients which consists of … pages enclosed with License
No .../YDCT-QLD dated issued by Traditional Medicine Administration of
Vietnam - Ministry of Health
Hanoi, [date]
DIRECTOR
[Location and
date]
Director of importing enterprise
(Signature, full name, seal)
APPENDIX
05
(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
No. ………….
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
------------------
REPORT ON STOCKTAKING
OF HERBAL INGREDIENTS CONTAINING ADDICTIVE INGREDIENTS, PSYCHOTROPIC
SUBSTANCES, PRECURSORS
To: Traditional
Medicine Administration of Vietnam - Ministry of Health
No.
Vietnamese name of
enterprise, used parts
Scientific name (Latin
name)
Quantity in stock
in the previous period
...
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Total quantity
Total quantity
used/sold in the period
Inventory on
[date]
Loss
Notes
...
...
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...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Report maker
[Location and date]
Director of importing enterprise
(Signature, full name, seal)
*Note: Reported quantity must be updated right before
the application for import license is submitted.
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APPENDIX
06
(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
Ministry of Health
TRADITIONAL MEDICINE ADMINISTRATION OF VIETNAM
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
------------------
No.
/YDCT-QLD
Hanoi, [date]
LICENSE FOR
IMPORT OF HERBAL INGREDIENTS
Pursuant to Circular No.
/2016/TT-BYT dated of the Minister of Health on herbal ingredient trading;
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In consideration of demand for imported herbal
ingredients in Official Dispatch No. … dated … of …
1. Traditional Medicine Administration of
Vietnam hereby permits ……….. to import the following herbal ingredients:
No.
Vietnamese name of
enterprise, used parts
Scientific name
(Latin name)
Packaging
Manufacturer
Manufacturing
country
Exporting country
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Quantity
Quality standards
1
2
3
4
5
6
7
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9
10
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Total quantity: …………………………………………………………………………………
Import purposes (2): ………………………………………………………………………
Import location: …………………………………………………………………………………..
Notes:
- The importer is responsible for quality of
imported herbal ingredients.
- The import shall comply with current regulations
on export and import of medicines and relevant regulations on pharmaceuticals,
the Law on prevention and treatment of infectious diseases, quarantine at the
border, and other regulations of law.
2. This License is valid for 01 year from
its date of issue.
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DIRECTOR
APPENDIX
07
(Enclosed with
Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
NAME OF
FACILITY
-------
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
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No. ………….
[location and
date]
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
NOTICE
of
FULFILLMENT OF
CONDITIONS FOR PROCESSING HERBAL INGREDIENTS
To: Traditional
Medicine Administration of Vietnam - Ministry of Health
1. Name of facility/enterprise:
2. Address
Tel:
Fax: ……………
3. Person in charge: Pharmacist [full name],
practising certificate No. … issued by the Service of Health of [province] on
[date]. Tel: ………..
We hereby notifies Traditional Medicine
Administration of Vietnam - Ministry of Health of our fulfillment of conditions
for processing herbal ingredients according to Circular No. …../2016/TT-BYT
dated … of the Minister of Health on herbal ingredient trading.
We hereby declares that, according to internal inspection
result, all conditions for processing herbal ingredients specified in Circular
No. …../2016/TT-BYT dated … of the Minister of Health are satisfied and that we
are totally responsible for such inspection result.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
DIRECTOR OF ENTERPRISE/FACILITY
(Signature, full name, seal)