Circular No. 09/VBHN-BYT dated July 09, 2014 of the Ministry of Health integrates the Circulars guiding the export and import of medicines and primary packaging of medicines

THE MINISTRY OF HEALTH

Circular No. 09/VBHN-BYT dated July 09, 2014 of the Ministry of Health integrates the Circulars guiding the export and import of medicines and primary packaging of medicines

Circular No. 47/2010/TT-BYT dated December 29^th2010 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 21^st2011 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 05^th2012.

2. Circular No. 38/2013/TT-BYT dated November 15^th2013 by the Minister of Health amending a number of articles of Circular No. 47/2010/TT-BYT dated December 29^th2010 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 01^st2014.

Pursuant to the Law on Pharmacy No. 34/2005/QH11 dated June 14^th2005;

Pursuant to the Law on drug prevention and fight No. 23/2000/QH10 dated December 09^th2000 and Law on amendments to the Law on drug prevention and fight No. 16/2008/QH12 dated June 03^rd2008;

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;

Pursuant to the Decree No. 79/2006/ND-CP dated August 09th 2006 by the Government specifying the implementation of a number of articles of the Law on Pharmacy;

Pursuant to the Decree No. 58/2003/ND-CP dated May 29^th2003 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 23^rd2006 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 12^th2007 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.

Article 2. Interpretation of terms

In this Circular, these terms can be construed as follows:

1.Country of originmeans 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.Amanufacturing establishmentis an establishment performing at least one stage of production and/or shipping finished products.

3. Commercial packaging of medicinesmeans 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 substancesmean pharmaceutical substances that contain radioactive substances used for diagnosis and medical treatment.

6.Radiopharmaceuticalsmean medicines that contain one or more radioactive pharmaceutical substances used for diagnosis or treatment.

7.Safe levelmeans the radioactivity threshold above which the radioactive substances are considered dangerous to humans and the environment.

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.

4. Traders may give entrustment with exporting medicines according to the Certificate of eligibility for medicine trading, excluding narcotic drugs, psychotropic medicines, medicine precursors and radiopharmaceuticals.

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;

b) Foreign traders supplying excipients, primary packaging of medicines and organizations/individuals specified in clauses 5, 6, 7, 8 and 9 of this Article are not required to be enterprises having License for operation involving medicines and medicine ingredients in Vietnam;

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;

dd) Medicine ingredients that are imported into Vietnam, excluding herbal ingredients, must have remaining duration of less than 36 months from the date of arrival in Vietnam; regarding ingredients giving duration equal to or less than 36 months, the date of arrival in Vietnam must be within 06 months from the date of production;

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:

a) If a vaccine/medical biologics containing antibodies for disease prevention and treatment (with or without number of registration for selling in Vietnam) is imported, after customs clearance, such vaccine/medical biologics shall be transported to the storehouse of the preserving enterprise according to the regulations and shall be used only when there is a document of the National Institute for Control of Vaccine and Biologicals verifying that the lot of imported vaccine/serum contains antibodies used for  disease prevention and treatment satisfies the quality and safety standards on experimented animals.

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).

b) The importer shall send monthly reports to Drug Administration of Vietnam - the Ministry of Health the export and import of medicines by email to[email protected]before 10^thdate of the next month; biannual reports in writing before July 10^thand annual reports before January 10^thof the next year.(Form No. 1b1 to b13).

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;

- Any Vietnam’s translation included in the documents shall be notarized according to the regulations (“notarize” in this case is construed as that a local notary office or a diplomatic mission, consular office or another office authorized by the foreign country to notarize the signature of the translator according to the law) and shall be enclosed with its original copy or the photocopy;

- 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 onhttp://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.

d) There shall be the certificate of conformance with Good medicine manufacturing practice or other certificates of conformance with the quality control system (ex: ISO 9001, etc.) issued by competent agencies of the country of origin and verified by the manufacturer.

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.

5. Regarding finished medicines without import registration number according to the regulations in Article 11 of this Circular, each type of medicine must be made in a separate order, except for medicines sharing all the following elements that can be imported in same document:

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 28^th2010.

Heads of units receiving donated medicines must take fully responsibilities for quality of medicines and shall use medicines effectively, reasonably and safely.

4. Donated medicines shall fulfill the following requirements:

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

MANAGEMENT OF IMPORT/EXPORT OF MEDICINES AND PRIMARY PACKAGING OF MEDICINES

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.

2. When exporting medicines/primary packaging of medicines other than those specified in clause 1 of this Article, the exporting unit carrying out customs procedures may not present the license for export issued by the Ministry of Health.

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 Administration of Vietnam - the Ministry of Health shall send the enterprise a containing explanation.

Article 10. Other medicines, excluding the ones specified in Article 9 of this Circular

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);

b) The Certificate of a Pharmaceutical Product. The Certificate of a Pharmaceutical Product may be replaced by the Free Sale Certificate (FSC) or the Certificate of Good medicine manufacturing practice (GMP). If there are multiple establishments involving in medicine production process, the importing establishment shall submit the GMP of all the involving establishments;

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);

b) Form No 6b;

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;

d) Form No. 7c;

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

1. Application:

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:

a) Medicines in the national target programs for health shall be imported via entrustment by enterprises having functions to import directly medicines. Labels of medicine shall have the sentence “For program not for sale”.

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.

Article 17. Medicines used for clinical trials, medicines used as samples for registration and medicines serving research, testing, inspection, research on bioavailability/bioequivalence

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.

2. Procedures:

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 23^rd2006 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.

- Within 30 days from the day on which the registration number of the medicine is issued, Drug administration of Vietnam shall issue an announcement about the List of medicine ingredients permissible to import.

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.

3. Import of medicine ingredients under the form of import license

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.

- Regarding medicine ingredients being narcotic drugs, psychotropic medicines, medicine precursors, an Inventory Report in according to Form No. 3 enclosed with this Circular is required.

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

Article 21. Vaccines, medical biologics being serums containing antibodies

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

APPLICATION AND PROCEDURES FOR EXPORT OF MEDICINES AND PRIMARY PACKAGING OF MEDICINES

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

Any medicines in Vietnam shall be issued with the Free Sale Certificate (FSC) or the Certificate of a Pharmaceutical Product (CPP) to be exported. The quantity of FSC and CPP that are issued shall be at the request of the establishment.

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

Article 24. Actions against violations

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

IMPLEMENTARYPROVISIONS

Article 25. Effect

This Circular takes effect 45 days after the day it is signed. Circular No. 06/2006/TT-BYT dated 16/05/2006 by the Ministry of Health is annulled; Circular No. 13/1998/TT-BYT dated 15/10/1998 by the Ministry of Health; regulations on import of vaccines and medical biologics in Circular No. 08/2006/TT-BYT dated 13/06/2006 by the Ministry of Health.

Any difficulties arising in the course of implementation of this Circular should be reported to the Drug administration of Vietnam - the Ministry of Health for consideration and solution./.

Certification of Integrated Document

For the Minister

The Deputy Minister

Pham Le Tuan

LIST

MEDICINE INGREDIENTS AND FINISHED MEDICINES BANNED FROM IMPORT FOR PRODUCING MEDICINES FOR HUMAN
(Issued with Circular No. 47/2010/TT-BYT dated December 12^th2010 by the Minister of Health)