Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export, import of medicines and packaging in direct contact with medicines

CIRCULAR

GUIDING THE EXPORT, IMPORT OF MEDICINES AND PACKAGING

IN DIRECT CONTACT WITH MEDICINES

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

Pursuant to the Law on Prevention and Combat of Medicines No.23/2000/QH10 dated December 09, 2000 and the Law amending, supplementing a number of Articles of the Law on Prevention and Combat of Medicines No.16/2008/QH12 dated June 03, 2008;

Pursuant to the Decree No.188/2007/ND-CP dated December 27, 2007 of the Government stipulating the function, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Decree No.79/2006/ND- CP dated August 09, 2006 of the Government detailing the implementation of a number of Articles of the Law on Pharmacy;

Pursuant to the Decree No.58/2003/ND-CP dated May 29, 2003 of the Government prescribing the control of the import, export and transit through Vietnam’s territory of narcotics, pre-substances, addictive medicines and psychotropic medicines;

Pursuant to the Decree No.12/2006/ND-CP dated January 23, 2006 of the Government detailing the implementation of the Commercial Law concerning international trading activities and activities of agents, purchase, sale, processing and transit of goods with foreign countries;

Pursuant to the Decision No.151/2007/QD-TTg dated September 12, 2007 of the Prime Minister issuing regulation of imported medicine not having registered number yet in Vietnam;

Ministry of Health guides the export, import of medicines and packaging directly contacted with medicines as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of governing

1. This Circular guides the export and import of medicines and packaging in direct contact with 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, the terms below are construed as follows:

1. Country of origin means the country that produces final dosage forms and/or goods lots shipped or country where the products are shipped to the importing country.

2. Manufacturing establishments mean the establishments performing at least one stage of production and/or finished products shipped.

3. Commercial packaging of medicines means packaging containing medicines and circulated together with medicines. Commercial packaging of medicines includes two types:

- Direct packaging means packaging containing in direct contact with medicines;

- Outside packaging means packaging used to package one or more medicine units having direct packaging.

4. The radioactive substance means substance emitting radiation due to nuclear fission, nuclear energy transitions, having its own level of radioactivity or total level of radioactivity of more than the exemption rate.

5. Radioactive pharmaceutical substances mean pharmaceutical substances that contain radioactive substances used for the diagnosis and treatment.

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

7. Exemption level from declaration, grant means the level of radioactivity that from such level or less the radioactive substances are considered harmless to humans, environment.

Article 3. Conditions and scope of organizations and individuals participating in export and import of medicines, packaging in direct contact with medicines

1. For traders who are enterprises of Vietnam:

a) Enterprises having certificates of eligibility for medicine trading and medicine warehouses obtaining standard "Good Storage Practice" (GSP) are imported directly and received entrusting to import finished medicines and raw materials for making medicines, vaccines and medical biological products, medicines from medicinal material, traditional medicines, radioactive medicines are exempted from declaration licensing in accordance with the business scope stated in the certificate of eligibility for medicine trading and GSP certificate;

b) Enterprises trading medical equipment and enterprises having certificates of eligibility for medicine trading are imported directly and received entrusting to import medical biological products for In Vitro diagnosis;

c) Enterprises having certificates of eligibility for medicine trading and certificate obtaining standards "Good Manufacturing Practice" (GMP) are imported raw materials for medicine manufacture of such enterprises and sold to other medicine production enterprise;

d) Production enterprises having certificates of eligibility for medicine trading from medicinal materials are imported to serve the needs of enterprises’ manufacturing and sold to other medicine production establishments, the traditional examination and treatment establishments;

đ) Enterprises having certificates of eligibility for medicine trading and valid permits to carry out radiation work granted by the competent authority are imported directly radioactive medicines not exempted from the declaration, grant.

2. For traders who are enterprises with direct foreign-owned capital in Vietnam having certificates of eligibility for medicine trading (the scope of medicine production) are imported raw materials for medicine production of such enterprises. The export and import of medicines not serving for medicine production of such enterprises will be guided by the Ministry of Health in other documents.

3. Vietnam traders having certificates of eligibility for medicine trading are exported, entrusted for export, received entrusting for export of medicines, except for narcotics, psychotropic medicines, pre-substances used as medicines and radioactive medicines.

4. Traders are allowed to entrust for export of medicines in accordance with the scope of activities specified in the certificates of eligibility for medicine trading, except for narcotics, psychotropic medicines, pre-substances used as medicines and radioactive medicines.

5. Organizations and individuals who are not traders on the basis of contracts signed under the provisions of law, are entrusted for export, import of medicines to serve the needs of use of such organizations and individuals, except for narcotics, psychotropic medicines, pre-substances used as medicines and radioactive medicines.

6. Representative offices of foreign traders having operating licenses on medicines and materials for making medicines in Vietnam, Vietnam traders having certificates of eligibility for medicine trading are allowed to import medicines to serve the circulation registration (including medicines for testing, appraising as required by the registration of medicines).

7. The establishments having function of research and testing, the medicine production establishments are permitted to import medicines for research and testing.

8. The medical examination and treatment establishments of the provinces, cities, branch health and organizations of Vietnam (referred to as the Vietnam parties) are allowed to receive medicine assisted, given from charitable organizations, NGOs, foreign individuals, overseas-based Vietnamese (referred to as foreign parties) and are responsible for the use of medicines effectively, safely, reasonably, proper aid purposes.

9. Organizations and individuals with clinical testing medicine are imported medicines for the clinical testing according to research plan of testing medicines on such clinique approved by the Ministry of Health.

10. Organizations and individuals having such research plan of bioavailability, bioequivalence approved by the specialized technical agency authorized by the Ministry of Health are imported medicines for the study of the bioavailability, bioequivalence.

11. Traders are allowed to import, export packaging in direct contact with the medicine.

12. For foreign traders supplying medicines into Vietnam:

a) Foreign traders supplying medicines, pharmaceutical materials, medicines from pharmaceutical materials, traditional medicines into Vietnam must be enterprises having operating license on medicines and medicine-making materials in Vietnam;

b) Foreign traders providing excipients and packaging in direct contact with medicines and organizations and individuals stipulated in clauses 5, 6, 7, 8 and 9 of this Article are not required to be enterprises having operating license on medicines and medicine-making materials in Vietnam;

c) Where the medicines needed for prevention and treatment demand of disease and raw materials needed for domestic medicine production needs but the enterprises having operating license on medicines and medicine-making materials in Vietnam do not provide or provide not enough demand, Drug Administration Department- Ministry of Health considers and decides to allow imports from the prestige companies providing medicine all over the world.

Article 4. General provisions on import and export of medicines

1. Medicine quality, packaging in direct contact with imported medicines

Traders that manufacture, import, export, supply, entrust, receive entrusting of import and export of medicines, packaging in direct contact with the medicines are responsible for the quality and safety of imported medicines according to provisions of Pharmacy Law, Commercial Law and other regulations on the management of current medicine quality.

2. Expiry date of imported medicines:

a) Finished medicines imported into Vietnam with expiry date of more than 24 months, the remaining expiry date must be at least 18 months from the date of arrival in Vietnam. For medicine with expiry date of equal to or less than 24 months the remaining expiry date must be at least 12 months from the date of arrival in Vietnam;

b) Vaccines, medical biological products without registration numbers, when imported into Vietnam they must have a remaining expiry date of at least by 2/3 of expiry date from the date of arrival in Vietnam;

c) Vaccines, medical biological products with valid circulation registration numbers in Vietnam, when imported into Vietnam, they must have a remaining expiry date of at least by 1/2 of expiry date from the date of arrival in Vietnam;

d) Biological products used in In Vitro diagnosis with expiry date of equal to or less than 12 months when imported into Vietnam, they must have a remaining expiry date of at least by 03 months from the date of arrival in Vietnam;

đ) Raw materials for making medicines imported into Vietnam, except for pharmaceutical materials, must have remaining expiry date of more than 36 months from the date of arrival in Vietnam, for raw materials with expiry date of equal to or less than 36 months, the arrival date of the Vietnam s ports is not exceeded 06 months from date of manufacture;

e) Medicine of aid, humanitarian aid with expiry date of more than or equal to 24 months, the remaining expiry date of medicine must have a minimum period of 12 months from the date of arrival in Vietnam. Where medicine with expiry date of less than 24 months, the remaining expiry date from the date of arrival in Vietnam is at least equal to 1/3 of medicine’ expiry date;

g) The medicines and medicine-making materials not meeting the regulations on expiry date of medicines in points a, b, c, d and đ of this clause but ensuring the quality and need to be imported to serve the needs of treatment, demand in the domestic production of medicines, Drugs Administration Department - Ministry of Health shall consider and decide and be responsible for grant of import permits.

3. Requirements for testing sheet:

When making customs clearance procedures, the enterprises importing medicines, packaging in direct contact with medicines must present to the customs of border gate the original of testing sheet of the production establishments certified obtaining quality standards for each batch of imported medicines of manufacturers except for pharmaceutical materials and medicines specified in Article 12, 13, 14, 15, 17 and 18 of this Circular.

Customs of border gate shall save a copy of testing sheet stamped confirmation of the importing enterprise.

4. Intellectual property rights on medicines, packaging in direct contact with the medicines:

Traders that manufacture, import, export, supply, trust, receive entrusting of import and export of medicines, packaging in direct contact with medicines must take responsibility for intellectual property rights of medicines, packaging in direct contact with medicines due to the establishments produce, import, export, supply, entrust import and export.

5. Testing, clinical testing for vaccines and medical biological products as serum containing antibodies imported:

a) For vaccines and medical biological products as serum containing antibodies used to disease prevention and treatment with or without circulation registration numbers in Vietnam imported, after the customs clearance, they are taken to the warehouse of enterprise for storage as prescribed and only allowed to put into use when having written certification of the National Institute for Expertise of Vaccines and Medical Biological Products that lots of vaccines, serum containing antibodies used to prevent and treat disease imported obtain standards of quality and safety on experimented animals.

b) For vaccines and medical biological products as serum containing antibodies for disease prevention and treatment without the import registration number used for the programs and national projects, they are required to implement clinical trial of medicines prepared as prescribed in Decision No.01/2007/QD-BYT on 11/01/2007 of the Minister of Health stipulating on clinical trial of medicines.

Particularly for vaccines and medical biological products as serum containing antibodies for disease prevention and treatment without circulation registration numbers but they are pre-tested by the World Health Organization (WHO) and circulated worldwidely by the international organizations which regularly cooperate with Vietnam in the medical field such as WHO, UNICEF ... aid to Vietnam, as the case by case basis, the Drugs Administration Department - Ministry of Health requires proof of cold chain implementation and results of safety testing satisfactory on human in the field, then they are allowed put to use.

c) With respect to vaccines and medical biological products as serum containing antibodies for disease prevention and treatment imported under the provisions of Article 13, 14, 15 and 16 of this Circular, if necessary, the Drugs Administration Department - Ministry of Health will require safety testing on humans in the field and after obtaining satisfactory results on safety testing on humans in the field, they are allowed to put into use.

6. Labels of imported medicines:

For labels of imported medicines, they must be complied with the provisions of Decree No.89/2006/ND-CP dated 30/9/2006 of Government on the goods labels, the provisions in Circular No.04/2008/TT-BYT dated 12/05/2008 of the Minister of Health on guiding labeling of the medicines except for labels prescribed in Article 12, 13, 14, 15, 16, 17 and 18 of this Circular.

7. Declaration, redeclare the price of medicines:

The declaration and re-declaration of the price of imported medicines is made in accordance with provisions in Circular No.11/2007/TTLT-BYT-BTC-BCT on 31/08/2007 by the Health Ministry.

- The Ministry of Industry and Trade guides the implementation of state management on prices of medicines for human use.

8. Report:

a) Within 10 days from the date that vaccines, medical biological products as serum containing antibodies are imported into warehouses, importing enterprises sends import report for each lot of imported goods to the Drugs Administration Department - Ministry of Health and the National Institute for Expertise of Vaccines and Medical Biological Products (Form 1a).

b) Importing enterprises must report to the Drugs Administration Department - Ministry of Health on situation of import and export of medicines monthly in electronic file to the mailbox [email protected] before 10th of next month; written 06 month report before July 10 and the whole year report before January 10, of next year. (Form 1b1 to b13).

c) Enterprises importing medicines for shows, exhibition, fairs and other cases of temporary import for re-export: Within 10 days after the end of shows, exhibition, fairs activities or expiry of temporary import, enterprises must re-export and send written report to the the Drugs Administration Department -Ministry of Health on the number and situation of re-export (Form 1C).

9. Fees:

Enterprises importing medicines must pay fees as prescribed in Decision No.44/2005/QD-BTC 12/07/2005 of the Minister of Finance stipulating the regime of collection, remittance, management and use of fees for appraising trade, commerce with conditions in the field of health, fees of criteria evaluation and conditions for practicing medicine, fees for licensing import, export and certificate of practicing medicine, pharmacy; Decision No.59/2008/QD-BTC dated 21/07/2008 on amending and supplementing Decision No.44/2005/QD-BTC dated 12/07/2005 of the Minister of Finance stipulating the regime of collection, remittance, management and use of fees for appraising trade, commerce with conditions in the field of health, fees of criteria evaluation and conditions for practicing medicine, fees for licensing import, export and certificate of practicing medicine, pharmacy and other concerned legal documents.

10. The effective duration of the import, export permits of medicines: Import, export permits of medicines are valid for a period of 01 year from the date of signing.

11. Legal documents in import dossier of medicines:

a) Certificate of pharmaceutical product (CPP), certificate of free sale (FSC) certificate of obtaining standards of Good Manufacturing Practice (GMP) or certificates obtaining equivalent standards for In Vitro diagnostic biological product may be submitted the original or copy or a Vietnamese translation from foreign languages, but required to meet specific regulations for each type of certificate defined in point b, point c or point d of this clause and the general provisions as follows:

- In case of handing in the original: the original must be had all signatures directly, full name, title, the date of issuance and certified seal by the competent authorities of the home country where granted the certificate; and it must be legalized consulate in diplomatic missions of Vietnam under the law regulations on consular legalization, unless the legal documents issued by the competent authorities of the countries signed the Agreement on mutual legal assistance with Vietnam;

- In case of handing in the copy: A copy duly authenticated in accordance with the law regulations of Vietnam on the authentication of copies from the originals by the competent agencies of Vietnam;

- Where handing in the Vietnamese translations from foreign languages: Vietnamese translation must be notarized public in accordance with provisions (“notarized public” is interpreted to be the local notary public agencies or diplomatic missions, consular agencies or other agencies authorized from foreign countries in the signature certification of the translator in accordance with the law regulations) and must submit together with the original or copy of certificate under the above provisions;

- Validity of the certificate: the validity must be indicated specifically on the certificate and must be valid at the time of evaluation; the written extension of the certificate shall not be accepted. Where the certificate is not specified the validity, then only the certificates issued within 24 months from the date of grant are accepted.

b) For certificate of pharmaceutical products, apart from meeting the provisions in point a of this clause, it also must meet the following provisions:

- Must have written certification of medicines permitted for circulation in the country of origin, if medicines are not circulated in the country of origin, the supply company must send the reason explanations to the Drugs Administration Department - the Ministry of Health for consideration;

- If the medicine is produced through many stages in different countries, it can not be identified the sole country of origin, the importing establishment of medicine must hand in CPP of the country producing the final dosage form or CPP of the country sending factory’s output. Where there is no CPP of both countries of origin above, the Drugs Administration Department - the Ministry of Health will consider the CPP acceptance of the country where the product is shipped to the importing country;

- Where there is no CPP of the countries of origin mentioned above, only CPPs of the medicine which are approved by the competent authorities of one of the countries such as UK, France, Germany, USA, Japan, Australia, Canada or the agencies of assessment and evaluation of medical products in Europe – EMEA are accepted;

- Issued by competent Medicines Administration agency (the list of available http://www.who.int WHO) of the country of origin; issued under form of WHO applied to the quality certification system of products circulated in international trade.

c) For certificate of free sale, in addition to meeting the provisions in point a of this clause, it also must meet the following provisions:

- Must have written certification of medicines permitted for circulation in the country of origin, if medicines are not circulated in the country of origin, the supply company must send the reason explanations to the Drugs Administration Department - the Ministry of Health for consideration;

- Issued by the competent authorities of the country of origin, having sufficient information on the composition, concentration, dosage form and validity of the certificate.

d) Certificate of obtaining standards of Good Manufacturing Practice, or the certificates of obtaining other quality management systems (eg ISO 9001 ...) and must be issued by the competent authority of the country of origin, confirmed the name and address of the manufacturer.

Article 5. Regulations on the making of goods orders, languages​​and forms of dossiers

1. Order of import and export of medicines, packaging in direct contact with the medicines is made in 03 copies in the form appropriate to each medicine prescribed in this Circular. After being approved, 02 copies shall be kept at the Drugs Administration Department - the Ministry of Health, 01 copy is sent to the importing, exporting enterprises of medicines. The copy sent to the importing, exporting enterprises of medicines is stamped "dispatch for enterprise" for making customs procedures at border gates. Order of import and export of narcotics, psychotropic drugs, pre-substances used as medicines, including the types of single substances or in combination with the valid circulation registration numbers are made into 02 copies.

2. Where enterprises receiving entrusting of import and export of medicines, it must specify the name of the entrusting company of importing, exporting medicines on the order.

3. Files, documents attached to orders to be prepared on A4 size paper, bound into 01 sets firmly. Dossiers must be sorted by the right order of cataloging, which are separated between the parts. The separated parts must be numbered for easy reference and stamped certification by importing enterprise in the first page of each part of the entire dossier and stating clearly on the cover page: name the importer, order number, date of order, and kind of order.

4. The language used in the medicine import dossiers:

Dossier of foreign medicines import must be written in Vietnamese or English. If the dossier is written in English, the information in the instruction manual of medicine must be written in Vietnamese, except for the following contents are allowed to write in other languages with Latin root words:

a) Name of proprietary medicines, international nonproprietary or generic name of the medicine;

b) International nonproprietary names or scientific names of ingredients, ingredient quantities of medicines in the cases of unable to translate into Vietnamese or translated into Vietnamese but it is nonsense;

c) Name and address of the foreign enterprises of production, manufacture franchise of medicines.

5. For finished medicines without import registration number under the provisions of Article 11 of this Circular, each medicine must be made in a separate order, except for medicines that share all the following elements can be imported in same dossier:

a) Name of medicine;

b) Dosage form;

c) The formula for a dose unit (for the medicine form of single dose) or the same concentration content (for multi-dose medicine);

d) Manufacturer.

Article 6. Some other provisions

1. Imported medicines circulated on the market must meet the provisions in clause 1 of Article 36 of the Pharmacy Law.

2. Imported medicines for projects and programs of national health goals, medicines of aid, humanitarian aid; medicines imported for the purpose of clinical trials, as the registration sample, for research, testing, appraisal; medicines imported for participation in shows, trade fairs and exhibitions must be used for right purposes, right objects and not allowed to circulate on the market.

3. Medicine of aid imported by organizations and individuals stipulated in clause 8, Article 3 of this Circular, after the receipt, the receiving unit must set up a council to inventory, evaluate and classify medicines and warehousing to manage. Only the medicine ensures quality, and its expiry date still remains, is allowed to put into use for treatment. For medicines not allowed to be used, it is required to set up a council to conduct the medicine destruction in accordance with provisions of the Circular No.09/2010/TT- BYT dated April 28, 2010 on quality management, ensuring not to cause environmental pollution.

Heads of units that receive aid medicines must bear full responsibility for the quality of medicines, using medicines effectively, reasonably and safely.

4. Medicines of aid, humanitarian aid must meet the following requirements:

a) Must be allowed to circulate in the home country. For vaccines and medical biological products as serum containing antibodies, they must be of the list of vaccines and medical biological products that are recommended to use by Health Organization;

b) Must meet the requirements of actual use of the aid recipient unit and the national medicine policy of Vietnam;

c) Not being on the list of addictive medicines, the list of raw materials and finished medicines banned from import for making medicines for human use (except for medicine import for program, national projects that were approved by the government);

d) Must have clear origin and ensure standards of quality, safety, use efficiency in both aid country and Vietnam. Vaccines, medical biological products of aid must be tested obtaining the quality standards of national accreditation agencies of the home country or the competent authorities for the import shipments, and must assessed quality by the National Institute for Expertise of Vaccines and Medical Biological Products before they are imported;

đ) Must be packed in suitable packaging items, stating the name of medicine, active substance, concentration, dosage form, packing, together with instructions manual for use of medicines and a detailed list included each packing unit.

e) In special cases, medicine of aid for research programs do not meet the provisions of points a, b, c, d and đ of this clause, may be considered for the receipt based on legal documents, concerned technical of the research programs.

5. Pharmaceutical materials used for production, preparation, and traditional medicines in the medicine manufacturing establishments, medical examination, and treatment establishments by traditional medicines for the disease prevention and treatment for human must meet quality standards and provided by the sufficient condition establishments for medicine trading.

6. For radioactive medicines, in addition to the implementation of the provisions of this Circular, they shall comply with the provisions of law relating to radiation safety.

Chapter II

MANAGEMENT FORMS OF IMPORT AND EXPORT OF MEDICINES

AND PACKAGING IN CONTACT WITH MEDICINES

Article 7. Import of medicines, the packaging in direct contact with medicines

1. Forbidden to import to make medicines for human use the finished medicines and medicine-making materials specified in the list of raw materials and finished medicines banned from import for making medicines (Annex).

2. Medicines with valid circulation registration numbers, except for narcotics, psychotropic drugs, pre-substances used as medicine imported by demand are not required to request for import permits or certification of imported goods order.

3. Medicines, packaging in direct contact with imported medicines required to have import permit by the Drugs Administration Department-Ministry of Health include:

a) Addictive medicines, psychotropic drugs, pre-substances used as medicines, including those in single or mixed substances with the valid circulation registration numbers;

b) Finished medicines, raw materials used for making medicines, vaccines and medical biological products without the registration number;

c) Packaging in direct contact with medicines.

Article 8. Export of medicines, packaging in direct contact with medicines

1. Addictive medicines, psychotropic drugs, pre-substances used as medicines, including those in single or mixed substances when exporting, it is required to have export permit of the Drugs Administration Department- Ministry of Health.

2. Medicines, packaging in direct contact with medicines, except for those specified in clause 1 of this Article as exporting, exporters make procedures directly with the customs of border gate, without required to have export permit of the Ministry of Health.

Chapter III

RECORDS AND PROCEDURES FOR IMPORT OF MEDICINES, PACKAGING IN

CONTACT WITH MEDICINES, TESTING OF IMPORTED MEDICINES

Item I. IMPORT OF MEDICINES HAVING VALID REGISTRATION NUMBER

Article 9. Narcotics, psychotropic drugs and pre-substances used as medicines

1. Dossier:

a) Import order (Form 2a, 2b);

b) Inventory report of addictive medicines (or psychotropic medicines, pre-substances used as medicines) (Form 3).

2. Procedures:

The enterprises send dossiers to the Drugs Administration Department-Ministry of Health. Within 15 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall issue the import permits. In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 10. Other medicines, except for those specified in Article 9 of this Circular

Exporting enterprises make procedures directly at the border gate customs and present a list of imported medicines to border-gate customs (Form 4) together with the original or copy notarized public validly the following documents:

a) The permit for circulating products or the decision to grant circulation registration numbers; other documents to allows the change, supplementation or corrections (if any);

b) Operating license on medicines and medicine-making materials in Vietnam for foreign companies to supply medicines, unless the traders specified in point b, c, clause 12, Article 3 of this Circular.

Item II. IMPORT OF MEDICINES WITHOUT CIRCULATION REGISTRATION NUMBER

Article 11. Finished medicines containing pharmaceutical substance without registration number or such pharmaceutical substance having the registration number but not meeting sufficient treatment needs, medical biological products used for disease prevention, treatment, diagnosis

1. Conditions and number of medicines considered for import permits:

Comply with the provisions of Article 7 of Decision No.151/2007/QD-TTg dated 12/09/2007 of the Prime Minister promulgating the Regulation on the import of medicines without registration numbers in Vietnam.

2. Dossier:

a) Import order (Form 5a, 5b, 5c, 5d, 5đ);

b) Certificate of pharmaceutical products. Where having no certificate of pharmaceutical products, it can be replaced by the FSC and GMP. Where there are many production establishments participating in the production of medicines, the importing establishments must hand in GMP certificate of all production establishments participating in the production of finished products;

c) Standard and testing methods of quality of medicines;

d) Medicine labels and instruction manual with seal of importers, including 01 set of the original label with the original instruction manual of the medicine being circulated in reality in the country of origin (excluding vaccines, medical biological products); 02 sets of labels expected for circulating in Vietnam together with instruction manual in Vietnamese;

đ) The inventory report for addictive medicines, psychotropic drugs and pre-substances used as medicine (Form 3);

e) Preclinical and clinical records for medicine containing new pharmaceutical substances, medicines with new combinations of circulating pharmaceutical substances.

3. Procedures:

The enterprises send dossiers to the Drugs Administration Department-Ministry of Health. Within 20 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits. In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 12. Rare medicines, medicines for the treatment needs of the hospital in special cases

1. Dossier:

a) Import order (Form 6a);

b) Reserves for rare medicines, medicines for the treatment needs of the hospital in special cases (Form 6b);

c) The documents specified at points b, c, d, đ and e, clause 2, Article 11, except for the following cases:

- Enterprise organizing chain of pharmacies obtaining standard "good pharmacy practice" GPP needs to import the list of rare medicines and medicines imported for the needs of hospital treatment in special cases to sell at the pharmacies obtaining GPP in the system: it must have document stating clearly the reason for not yet supplying dossiers, original testing sheet, and commitment to take responsibility for ensuring the quality of imported medicines;

- Enterprises importing medicines on the list of rare medicines, medicines imported for the needs of hospital treatment in special cases or the medicines with active substance, concentration, contents, dosage form without registration number for circulation in Vietnam but recorded in specialized documents but unable to offer the records specified in clause 2 of Article 11 of this Circular and original testing sheet of the imported medicine lots, the records must be included: Written reason statement that are unable to provide records of imported medicines, original testing sheet of medicines lots and commitment on ensuring the quality of imported medicines; report of medicine use (demand for use, safety and effectiveness of medicine treatment).

2. Procedures:

The enterprises send dossiers to the Drugs Administration Department-Ministry of Health. Within 15 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits. In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 13. Vaccines and medical biological products as special treatment needs of the treatment facilities, establishments of vaccination and testing establishments

1. Dossier:

a) Import order (Form 7a);

b) Reserves of vaccines, medical biological products of the establishments of vaccination, testing establishments (Form 7b);

d) The supplier’ commitment on quality assurance of vaccines and medical biological products provided to Vietnam (Form 7c);

đ) The attached documents (if any) include: Certificate of production facilities obtaining GMP standards or certificate of production facilities obtaining standard of quality management system (ISO) issued by the competent agencies (for In vitro diagnostic medical biological products), permits for the circulation of vaccines and medical biological products, permits for the circulation in some other countries where such vaccines and medical biological products are registered circulation. In special cases, the companies have not provided enough materials or vaccines, medical bio-products not meeting the provisions in points b, c, and d, clause 2 of Article 4 of this Circular but they are necessary for needs of use, the Drugs Administration Department - Ministry of Health shall consider and decide.

2. Procedures:

The enterprises send dossiers to the Drugs Administration Department-Ministry of Health. Within 15 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits and require to send dossier, samples to the National Institute for Expertise of Vaccines and Medical Biological Product for vaccines, medical biological products imported in case of necessity.

In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 14. Medicines meeting urgent needs for prevention of disease, remedies of natural disaster

1. Dossier: import order (Form 8);

2. Procedures:

The enterprises send dossiers to the Drugs Administration Department-Ministry of Health. Within 05 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits. In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 15. Medicines for the programs of national health goals

1. Dossier:

a) Import order (Form 9);

b) Documents issued by the competent authorities on the import of medicines for the program of national health goals (if necessary the Drugs Administration Department-Ministry of Health may request records under the provisions of points b, c, d and e, clause 2 of Article 11 of this Circular);

c) With respect to vaccines and medical biological products as serum containing antibodies used for disease prevention and treatment, apart from the papers prescribed at points a and b, clause 1 of this Article, it shall also be required to add the following documents:

- A certificate of the competent authority of the home country for permitting the circulation or export of vaccines and medical biological products;

- Certificate of production establishment obtaining GMP standard;

- Testing paper of obtaining the quality standard of vaccines, medical bio-products of the national accreditation agency or other competent authorities of the home country for lots of imported goods (certified true copy of the importer);

- Medicine test results on clinique or safe trial results on human in the field in accordance with provisions in point b, clause 5 of Article 4 of this Circular.

d) For vaccines, medical biological products imported as a result of successful bidding of national or international bidding in Vietnam, the documents as prescribed in sections 1, 2 and 3 point c, clause 1 of this Article considered by the program as reviewing bidding dossier, dossier requesting for import is not required to have the above papers.

2. Procedures:

a) Medicines of the program of national health goals must be entrusted through the enterprises with direct importing function of medicines. On medicine’s labels must be had the phase "program medicine not for sale".

b) Within 15 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits. In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 16. Aid medicines, aid medicines for humanitarian

1. Dossier:

a) A written request for import of the establishment receiving aid, humanitarian aid;

b) List of medicines of aid, humanitarian aid (Form 10);

c) Documents issued by the competent authority on the permission of the establishment to receive medicines of aid, humanitarian aid;

d) For vaccines and medical bio-products as serum containing antibodies used for disease prevention and treatment, in addition to the papers prescribed at points a, b and c, clause 1 of this Article, it is required to add the papers specified in section 1, 2 and 3 point c, clause 1, Article 15 of this Circular.

2. Procedures:

The importing establishments send dossiers to the Health Department in the area, where medicine contains the new pharmaceutical substance, the medicine with a new combination of such pharmaceutical substance circulated, vaccines, and medical biological products: The importing establishments send dossiers to the Drugs Administration Department-Ministry of Health. Within 15 working days from the date of receipt of order, and valid dossiers, the Health Department or the Drugs Administration Department -Ministry of Health shall consider for issuance of the import permits. In case of refusal, the Health Department or the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 17. Medicines used for clinical trials, as sample for registration and for the research, testing, appraisal, research of bioavailability/bioequivalence

Comply with the provisions in clauses 1, 2, 4, Article 9 of Decision No.151/2007/QD-TTg dated 12/9/2007 of the Prime Minister stipulating on the import of medicines without registration numbers in Vietnam.

1. Dossier:

a) Import order (Form 11a, 11b, 11c);

b) The research plan of such clinical medicine trial approved by the Minister of Health approval for imported medicines for clinical trials;

c) Research plan of such bioavailability, bioequivalence approved by the specialized technical agencies authorized by the Ministry of Health for imported medicines to study the bioavailability, bioequivalence;

d) The written approval of the competent authorities for the implementation of the research with approval or with written requirement of the competent authorities on the import of medicines for testing, appraisal;

đ) Where establishments of production, research, and testing require importing medicines to serve the research and testing made by them, they must attach to a written request and commitment of imported medicines for using only to serve the research and testing of them.

2. Procedures:

The importing establishments send dossiers to the Drugs Administration Department-Ministry of Health. Within 15 working days from the date of receipt of order, and valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits. In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 18. Medicines for participation in the shows, exhibitions and fairs and other cases of temporary import for re-export of medicines

Comply with provisions in clause 3, Article 9 of Decision No.151/2007/QD-TTg dated 12/9/2007 of the Prime Minister stipulating on the import of medicines without registration numbers in Vietnam and the provisions of Article 12 of Decree No.12/2006/ND-CP dated 23/01/2006 of the Government detailing the implementation of the Commercial Law regarding international trading activities and activities of agents, purchase, sale, processing and transit of goods with foreign countries.

Article 19. Medicinal-making materials, pharmaceutical materials without circulation registration numbers, packaging in direct contact with medicines

1. Dossier:

a) Import order (Form 12a, 12b, 12c, 12d);

b) The copy of quality standards and testing methods of materials, pharmaceutical materials, packaging in direct contact with the medicines for the raw materials, packaging with quality standards and testing methods of the manufacturers or copy of quality standards treatise of pharmacopoeia if raw materials are not applied the quality standards of the Pharmacopeia of European, the United Kingdom, United States, International Pharmacopeia, and of Japan;

c) For medicine-making materials as addictive medicines, psychotropic drugs, pre-substances used as medicines, they must be enclosed the inventory report (Form 3).

2. Procedures:

The Enterprises send dossiers to the Drugs Administration Department-Ministry of Health. Within 07 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits.

For medicine-making materials, as addictive medicines, psychotropic drugs, pre-substances used as medicines, within 15 working days from the date of receiving valid dossiers, the Drugs Administration Department-Ministry of Health shall consider for issuance of the import permits.

In case of refusal, the Drugs Administration Department-Ministry of Health shall send written replies, clearly stating the reasons.

Article 20. Radioactive medicines

1. For radioactive medicines in case of exemption of declaration, license grant: To comply with the provisions of Article 11 of this Circular.

2. For radioactive medicines in case of not being exempted from declaration, license grant: To comply with the provisions of Article 11 of this Circular together with the permits of conducting radiation works granted by the competent authorities for direct business enterprise of radioactive medicines.

Item III. INSPECTION OF IMPORTED MEDICINES

Article 21. Vaccines and medical biological products, serum containing antibodies

1. Dossier:

a) Form submitting samples for inspection;

b) The brief profile of production and inspection of lots of imported vaccines, imported medical biological products (a copy stamped and certified by the manufacturer);

c) Output permit granted by the competent agency of home country or of an another equivalent body together with each batch of imported goods lot (a copy stamped and certified by the Director of importer);

d) Proof of security on the cold chain in the transport of imported goods lot.

e) Sample of vaccines and medical biological products as serum containing antibodies imported for testing (the number of samples in accordance with provision for each type of vaccine, medical bio-products).

2. Procedures:

Importing enterprises shall send dossiers to the National Institute for Expertise of Vaccines and Medical Biological Product. Within 07 working days from the date of receiving the full samples and records as prescribed, the National Institute for Expertise of Vaccines and Medical Biological Product shall send written reply on the quality of vaccines, medical biological products and security on animal experimented of the vaccines, medical bio-products sent to the enterprises.

Chapter IV

RECORDS AND PROCEDURES FOR EXPORT OF MEDICINES AND

PACKAGING IN CONTACT WITH MEDICINES

Article 22. Narcotics, psychotropics drugs and pre-substance

1. Dossier:

a) Export orders (Form 13a, 13b);

b) Written permission for import of the competent authority of the importing country;

c) Addictive finished medicines as a form of combination specified in clause 2 of Article 1 of Circular No.10/2010/TT-BYT dated 29/4/2010 guiding activities related to addictive medicines; psychotropic finished medicines, pre-substance as a form of combination prescribed in clause 2, Article 1 of Circular No.11/2010/TT-BYT dated 29/4/2010 guiding activities related to psychotropic medicines, pre-substances used as medicines of export as the sample for registration, fairs, exhibitions, research are not required to have record as prescribed at point b, clause 1 of this Article but must give written explanation of the reason and purpose of exporting medicines of exporters;

d) For addictive medicines, psychotropic drugs, pre-substances without registration numbers: required to have enterprises’ commitments made under the export contract and not permitted to circulate the products not granted yet circulation registration numbers by the Ministry of Health.

2. Procedures:

Within 15 working days from receipt of order, and valid dossiers, Drugs Administration Department - Ministry of Health considers to grant the export license. In case of refusal, Drugs Administration Department - Ministry of Health shall send written replies, clearly stating the reasons.

Article 23. Other medicines which are not addictive medicines, psychotropic substances and pre-substances used as medicines in the form of single or mixed substances, packaging in direct contact with medicines

Medicines produced domestically are granted certificates of free sale (FSC) or a certificate of pharmaceutical product (CPP) for export. The number of FSC, CPP is issued at the request of the establishments.

1. Dossier:

An written request for a FSC or CPP (Form 14);

Where the importing countries require the establishments to hand in a FSC or CPP in the form prescribed by that State, the Drugs Administration Department-Ministry of Health may review to grant FSC based on the form requested.

2. Procedures:

a) Procedures for regranting FSC under the provisions of Article 13 of Decision No.10/2010/QD-TTg dated 10/02/2010 of the Prime Minister defining the certificate of free sale for the exports and imports.

b) Exporting establishments of medicines are not required to make dossiers registration procedures of traders for supply of FSC.

c) Within 05 working days from the date of receiving valid dossiers, Drugs Administration Department - Ministry of Health grants FSC or CPP (Form 15a, 15b).

Chapter V

HANDLING OF VIOLATIONS

Article 24. Handling of violations

1. In case the exporters and importers commit acts of counterfeiting or arbitrarily repair records, documents and legal documents of the authorities of Vietnam or of foreign countries; use false seal or forge the signature or mark of the importing establishments, manufacturing establishments and related establishments in the records of export, import of medicines, Drugs Administration Department-Ministry of Health sends a written warning to the establishments and stop receiving, considering the records of export, import of medicines of the establishments, specifically as follows:

a) Stop receiving, reviewing records of export and import of medicines of the establishments, within 03 months for the cases of first offense;

b) Stop receiving, reviewing records of export and import of medicines of the establishments for from 06 months to 12 months for the cases of violating 02 times within 12 months;

c) Depending on the seriousness of violations and Drugs Administration Department-Ministry of Health will send official dispatches to the manufacturers, companies providing medicines and stop receiving and reviewing dossiers of registration of medicines or stop receiving, reviewing operating registration dossiers on medicines and medicine-making materials in Vietnam of the foreign companies.

Apart from the above forms, Drugs Administration Department-Ministry of Health will disclose violating contents of the establishments on the website of the Ministry of Health; notify the Inspectorate, the customs authorities and other competent authorities for consideration and handling according to the law regulations.

2. Violating agencies, organizations and individuals, depending on the level of violations, will be stoped receiving, reviewing records for export, import of medicines or administratively sanctioned or examined for penal liability according to the law regulations.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 25. Effect

This Circular takes effect 45 days after its signing date. To annul Circular No.06/2006/TT-BYT dated 16/05/2006 of the Ministry of Health guiding the export and import of medicines and cosmetics; Circular No.13/1998/TT-BYT dated 15/10/1998 Ministry of Health guiding the receipt, management and use of foreign aid medicines into Vietnam; the regulations on the import of vaccines and medical biological products at Circular No.08/2006/TT-BYT dated 13/06/2006 of the Ministry of Health guiding the import of vaccines, medical biological products; chemicals, insecticide, antibacterial substance used in appliances and health and medical equipment.

During the implementation, if any problems arises, the units need to report to Drugs Administration Department - Ministry of Health for consideration and settlement./.