Circular No. 03/2016/TT-BYT herbal ingredient trading đã được thay thế bởi Circular 35/2018/TT-BYT Good Manufacturing Practices for pharmaceutical products và được áp dụng kể từ ngày 10/01/2019.
Nội dung toàn văn Circular No. 03/2016/TT-BYT herbal ingredient trading
MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 03/2016/TT-BYT | Hanoi, January 21, 2016 |
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
GENERAL PROVISIONS
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:
1. Raw herbal ingredients are natural herbal ingredients derived from plants, animals, minerals and may be used for medicines without undergoing any processing.
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.
2. Conditions for issuance of the Certificate of Eligibility for Drug Business that covers herbal ingredient trading:
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:
a) License to import herbal ingredients issued by Traditional Medicine Administration of Vietnam in accordance with this Circular.
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
1. Facilities:
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.
Article 8. Conditions applied to providers of herbal ingredient preservation services
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.
3. Design and construction of the warehouse:
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:
a) The Ministry of Health shall carry out inspection of implementation of GSP of herbal ingredient warehouses by facilities that import herbal ingredients and facilities and provide herbal ingredient preservation services.
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
1. Any facility satisfying conditions for trading in herbal ingredients that wishes to process herbal ingredients must satisfy the conditions specified in this Chapter.
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:
Depending on the scale, herbal ingredient production areas shall be placed in a way that is convenient for moving raw materials during the process of production between the preparation area and deep processing area.
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:
Depending on the requirements of each herbal ingredient processing method, the water source serving production must satisfy at least National Technical Regulation on domestic water.
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.
Article 17. Processing stages
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.
4. Labeling and packaging:
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.
3. Every record must have a date, bear the signature of the responsible person, and be retained at the facility until the expiration date of products.
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:
a) For providers of herbal ingredient preservation services:
- 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).
3. If the facility applies for a Certificate of Eligibility for Drug Business that covers commercial drugs, other ingredients, and herbal ingredients, only one application specified in Clause 1 and Clause 2 of this Article is required and only one Certificate of Eligibility for Drug Business shall be issued.
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).
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, 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.
2. Each importer shall submit 01 application specified in Article 25 of this Circular to Traditional Medicine Administration of Vietnam - Ministry of Health.
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
1. Every facility trading in herbal ingredients that obtained the Certificate of Eligibility for Drug Business, GSP certificate or GDP certificate that covers herbal ingredients before the effective date of this Circular may keep operating until the expiration date of such certificate.
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./.
| PP MINISTER |
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...............
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: …………………………
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 ……………..
| [Location and date] |
_______________
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
------------------
APPLICATION
for
Expansion of scope of Certificate of Eligibility for Drug Business/Change of business location or conditions
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: ………………………………………………………………………………
Or business conditions: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] |
_______________
1 Issuer of the Certificate of Eligibility for Drug Business
2 Specify the changed conditions
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
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: …………………………
Issued certificate of eligibility for drug business No. ……………………………… Type and scope of business: ……….…………………………………………..
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] |
_______________
1 Issuer of the Certificate of Eligibility for Drug Business
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: ……………
Practice certificate No. : ………… Issuer: ………. Year of issue: ……….. Expiration date (if any): …………..
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): …………..
Type of business:
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] |
_______________
1 Issuer of the Certificate of Eligibility for Drug Business
2 Corresponding technical documents are required if the reissuance involves inspection of business conditions
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 |
LIST OF PERSONNEL
Facility: …………………………………………………………………………………..
Owner: …………………………………….. Practice certificate No.: …………………………
Business location: ……………………………………….Tel:………………………………
Scope of business:
No. | Full name | Year of birth | Permanent residence | Qualification | Year of graduation Qualification issuer | Tasks | |
Male | Female | ||||||
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APPENDIX 03
(Enclosed with Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
…….1…… | SOCIALIST REPUBLIC OF VIETNAM |
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:
Address: Tel:
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: □
Type of business:
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: ………………………………………………………………………………
| ......, [location and date] |
Additional documents: Additional documents: Additional documents: | Date: Date: Date: | Signature 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. …………. | SOCIALIST REPUBLIC OF VIETNAM |
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 | Quality standards | Origin (country) | Name of supplier, country | Notes |
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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] |
APPENDIX 05
(Enclosed with Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
NAME OF IMPORTER No. …………. | SOCIALIST REPUBLIC OF VIETNAM |
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 | Purchased quantity this period | Total quantity | Total quantity used/sold in the period | Inventory on [date] | Loss | Notes |
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*Note: Reported quantity must be updated right before the application for import license is submitted.
APPENDIX 06
(Enclosed with Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health)
Ministry of Health | SOCIALIST REPUBLIC OF VIETNAM |
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;
Pursuant to Decision No. 4079/QD-BYT dated October 14, 2013 of the Minister of Health on functions, tasks, entitlements and organizational structure of Traditional Medicine Administration of Vietnam affiliated to the Ministry of Health;
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 | Unit | Quantity | Quality standards |
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
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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.
| 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 |
No. …………. | [location and date] |
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.
| DIRECTOR OF ENTERPRISE/FACILITY |
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