Circular No. 47/2009/tt-Byt: Circular 47/2009/tt-Byt Guide Import-Export Activities And The Packaging In Direct Contact With The Drug Because The Ministry Of Health Issued

Original Language Title: Thông tư 47/2010/TT-BYT: Thông tư 47/2010/TT-BYT hướng dẫn hoạt động xuất, nhập khẩu thuốc và bao bì tiếp xúc trực tiếp với thuốc do Bộ Y tế ban hành

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Pursuant to the law No. 34/2005/QH11 Pharmacy on Jun. 14, 2005;
Pursuant to the law, anti-drug no. 23/2000/QH10 on 9 December 2000 and the law on amendments and supplements to some articles of the law on drug prevention No. 16/2008/QH12 on 03 June 2008;
Pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
Pursuant to Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of a number of articles of the law on Pharmaceuticals;
Pursuant to Decree No. 58/2003/ND-CP dated May 29, 2003 the import control regulations, export, Vietnam territory transit narcotics, precursors, addictive drugs, smoking mental direction;
Pursuant to Decree No. 12/2006/ND-CP dated 23 January 2006 from the Government detailing the trade Enforcement Act of purchase and sale of goods and international dealers buying, selling, processing and transiting goods with foreign countries;
Pursuant to decision No. 151/2007/QD-TTg dated 12 September 2007 Prime Minister's Government issued regulations on the import of drugs yet to be registered in Vietnam;
The Health Ministry instructed export activities, importing the drug and packaging in direct contact with the drug as follows: chapter I GENERAL PROVISIONS article 1. Scope 1. This circular instruction exports, imports and the packaging in direct contact with the drug.

2. export and import trade to Africa by way of healing for ourselves and for families in the scope of this circular.

Article 2. Explanation of terms In this circular, the terms below are interpreted as follows: 1. The country of origin is produced water dosage and/or batch production or water where the product is transported to the importing country.

2. Production base is the base implementation of at least one stage of production and/or marketed products.

3. The packaging of medicinal products is the packaging contains smoking and circulation along with smoking. Commercial packaging of the drug consists of two types:-direct packaging is the packaging contained in direct contact with the drug;

-The outer packaging is the packaging used for the packing of one or several units are direct packaging.

4. Radioactive Substance emitted radiation due to nuclear decay process, transfer of nuclear energy levels, have a private activity or of greater activity levels of immunity.

5. the radioactive substance is the substance that contains radioactive material used for the diagnosis and treatment of the disease.

6. the radioactive Drug is a medication that contains one or more of the radioactive substance used to diagnose or treat disease.

7. to declare the exemption Level, licensing is the activity level from that level back down radioactive material are considered not harmful to humans, the environment.

Article 3. The conditions and the scope of the Organization, individuals involved in export, import, packaging in direct contact with the drug 1. For traders is Vietnam: a business) enterprise has the certificate of eligible drug business and standard drug store "good storage practice" (GSP) are directly imported and import trust smoking finished products, raw materials for making drugs, vaccines, medical products, medicines from medicinal herbs , Oriental medicine, radioactive medicines are exempt from licensing, declarations that suits the business range stated in the certificate of eligible drug business and the GSP certificate;

b) business enterprise medical equipment and enterprise with certificate of eligible drug business are directly imported and import Trust In Vitro Diagnostic products;

c) enterprise has the certificate of eligible drug business and has a standard certificate of "good manufacturing practice" (GMP) are imported raw materials to produce their own drug business and sell other drugs manufacturing enterprises;

d) producers have the certificate of eligible drug business from medicinal herbs are medicinal imports to serve the needs of corporate production and sale to the other drug production base, the basis of Oriental medicine clinics;

DD) enterprise has the certificate of eligible drug business and has a license to conduct radiation work by the competent authority granting validity to be directly imported radioactive medication not be exempt, licensing Declaration.

2. for the trader's business for foreign direct investment capital in Vietnam have qualified certificate of business (scope of production) are imported raw materials for its own drug production business. The export activities, importing drugs not served production of business will be the Ministry of health guidelines in other texts.

3. Vietnam traders have certificate of eligible drug business was exported, the export authorization, authorize the export of drugs, except smoking addictive, smoking mental direction, the precursors used and satire.

4. Trust allowed traders to import the drug in accordance with the scope of activities specified in the certificate of eligible drug business, except smoking addictive, smoking mental direction, the precursors used and satire.

5. The organization, not the individual traders on the basis of the contract to be signed as prescribed by law, be entrusted to export, the importing of drugs trustee serves the needs of your own organization, use that individual, except smoking addictive, smoking mental direction, the precursors used and satire.

6. Representative Office of foreign traders have active licenses on medicines and raw materials for making the drug in Vietnam, Vietnam traders have qualified certificate trading imported drugs registration staff (including the drug for testing audit, as required by the registration of drugs).

7. The base functions of research, testing, drug production facilities are allowed to import drugs serve research, testing.

8. The base doctor, healing of the province, city, health sectors and organizations of Vietnam (Vietnam-party) be allowed to take the drug aid from charities, non-governmental organizations, individual foreigners, Vietnam people abroad (foreign party) send gift aid, and responsible use of effective medications, proper, reasonable purpose aid.

9. organizations and individuals have clinical trial drugs be imported medicine to serve the clinical trials according to the outline of the study on clinical drug trials that are approved by the Ministry of health.

10. The organization, individuals have the outline of the available research, bio-equivalent to that approved in the specialized technical agency by the Health Ministry authorized the import of drugs to serve the research, bio-equivalent.

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

12. for foreign traders to provide drugs to Vietnam: a) foreign traders provide medicines, medicinal herbs, medicines from medicinal herbs, Oriental medicine in Vietnam must be a licensed business activity on smoking and smoking materials in Vietnam;

b) foreign traders provide excipient, the packaging in direct contact with the drug organization and individual, the provisions of clause 5, 6, 7, 8 and 9 of this Article are not required to be licensed businesses operate about smoking and smoking materials in Vietnam;

c) where the demand for drugs, and raw materials needed for domestic drug production needs but the licensed business activities of drugs and drug ingredients in Vietnam does not offer or provide insufficient demand, drug administration-Ministry of health review the decision allows imports from these businesses have provided tớn in the world.

Article 4. General provisions on import, export of drugs 1. The quality, the packaging in direct contact with the drug import traders produce, import, export, offer, trustee, received the mandate to import, export, packaging in direct contact with the drug must bear responsibility for the quality, the safety of drugs imported under the provisions of the law, commercial law and other regulations on the management of drug quality.

2. Limit use of imported drugs: a) Smoking finished products imported into Vietnam have expiration on May 24, the term used is left to the minimum is 18 months from the day to the port of Vietnam. For limited use drugs by or under 24 months expiration must be a minimum of 12 months from the day to the port of Vietnam;

b) vaccines, medical products not yet have registered, when imported into Vietnam are limited to use rest for at least 2/3 of the term refers to the port since Vietnam;

c) vaccines, medical products has a circulation registration number validity in Vietnam, when imported into Vietnam are limited to use rest for at least 1/2 term used since the day to the port of Vietnam;

d) diagnostic products limited In Vitro disease checking user by or under 12 months into the term Vietnam uses must rest for at least 12 months from the day to the port of Vietnam;

DD) ingredients for medicines imported into Vietnam, except medicinal herbs, to limited use left over 36 months from the date to the port of Vietnam, for limited user materials by or under 36 month, every day about to port Vietnam not too 6 months from the date of manufacture;

e) Smoking aid, humanitarian aid is limited using the greater than or equal to 24 months, term used rest of smoking must be a minimum of 12 months from the day to the port of Vietnam. Limited use drug case under 24 months expiration left from the day to the port of Vietnam at least 1/3 of the term in use of the drug;

g) drugs, raw materials do not meet the prescribed drugs on the expiration of the drug at points a, b, c, d, e in this account but make sure the quality and the need to serve the needs of treatment, demand the production of drugs in the country, drug administration-Ministry of health review decision and be responsible for importing.

3. Requirements for test votes:


When do the customs, the import business of drugs, the packaging in direct contact with the drug are required to present the Customs gate a test vote of major production facilities quality standard certification for each batch of imported medicine manufacturers except medicinal herbs and drugs prescribed in article 12 , 13, 14, 15, 17 and 18 of this circular.

The Customs gate to save a copy of the slip testing has the stamp of confirmation of import business.

4. Ownership of intellectual property, the bitter irony of the packaging in direct contact with the drug: traders produce, import, export, offer, trustee, received the mandate to import, export, packaging in direct contact with the drug to responsible ownership of reflux of drug, the packaging in direct contact with the main drug production base import, export, deliver, import-export, trustee.

5. Test, test drugs on clinical for vaccines, medical products is the serum that contains antibodies to import: a) for vaccines, medical products is the serum containing the antibodies used to prevent and cure have registered or have not had the registration number circulating in Vietnam after import customs clearance are taken to warehouses of business maintenance as required and are only allowed out once to have the text of the national testing of vaccines and medical products confirm the batch of vaccine, serum containing the antibodies used to prevent and cure the imports of standard quality and safety on animal experiments.

b) for vaccines, medical products is the serum containing the antibodies used to prevent and cure have yet to be registered for the import program, national projects to make clinical trials on medicines prescribed in decision No. 01/2007/QD-BYT on January 11, 2007 by the Minister of health regulations on clinical trials on the drug.

Particularly for vaccines, medical products is the serum containing the antibodies used to prevent and cure circulation registration number yet but that is the World Health Organization (WHO) auditing and that the money was in circulation world-wide contact due to the international organization which regularly cooperate with Vietnam in the medical field such as the WHO UNICEF, ... aid to Vietnam, tựy each case specifically, drug administration-Ministry of health requested evidence make the cold chain and have satisfactory results on the safety test on people at the new address are allowed to put to use.

c) for vaccines, medical products is the serum contains antibodies used to prevent and cure are imported under the provisions of article 13, 14, 15 and 16 of this circular, where necessary, drug administration – the Ministry of health will require safety testing on people in the field and after satisfactory results regarding safety testing on real people the new address is allowed to put to use.

6. Label the drug import: import drug Labels must comply with the provisions of Decree No. 89/2006/ND-CP dated 30/9/2006 by the Government on the regulations, húa labels in circular No. 03/2008/TT-BYT on 12/05/2008 of the Minister of health on drug labeling guidelines except for the label of the drugs specified in article 12 , 13, 14, 15, 16, 17 and 18 of this circular.

7. To declare, enumerate back drug prices: the Declaration, declared again the price of imported drugs made in accordance with circular No. 11/2007/TTLT-BYT-BTC-BCT on 31/8/2007 of the Ministry of health, Ministry of Finance-Industry guidelines state management on prices of medicines for people.

8. report: a) In Vung Tau for 10 days since the vaccines, biological medical is the serum containing the antibodies are imported the importer importing the report for each import shipment of drug administration, Ministry of health and the national testing of vaccines and medical products (1a).

b) importer must report on Drug Administration-Ministry of health, the situation of imports of medicines monthly by electronic file to the mailbox qlkdd@dav.gov.vn before 10 months later; report 6, in writing before July 10, and both report the year before October 1 of the following year. (Model number 1b1 to b13).

c) drug import business to participate in the fair, the exhibition gallery and the temporary import, re-export case: within 10 days after the end of works on display, exhibit or the expiration of a temporary import to re-export and must have written the report drug administration-Ministry of health about the number and situation of rebirth (1 c) 9. Fees: drug import business fees prescribed in decision No. 44/2005/QD-BTC dated July 12, 2005 the Minister of finance prescribed modes of Garner, filed, management and use of the evaluation fee conditional trade business in the health sector, standard appraisal fees and conditions of practice of medicine licensing fees, export, import and certification of medical practice, pharmacy; Decision No. 59/2008/QD-BTC dated 21/07/2008 amending and supplementing decision No 44/2005/QD-BTC dated July 12, 2005 the Minister of finance prescribed modes of Garner, filed, management and use of the evaluation fee conditional trade business in the health sector, standard appraisal fees and conditions of practice of medicine licensing fees, export, import and certification of medical practice, pharmacy and other legal texts concerned.

10. Term of validity of the import licence, export licence, import drugs: export of drugs worth 1 year from the date of signing.

11. legal profiles in the profile and import drugs: a) the certificate of pharmaceutical product (CPP), the free circulation of certificates (FSC), standard certificate of good manufacturing practice (GMP) certificate or the equivalent standard for In Vitro diagnosis products can submit the originals or copies or Vietnamese translation from a foreign language but must meet the specific regulations for each type of certificate prescribed in points b, c or d this clause and the General rules are as follows:-case filed a key: A key must have full direct signature, name, title, stating the date of issue and validation stamp of competent authority country certification; must be legalized in consular representative offices of Foreign Affairs Vietnam under the provisions of the law on the legal Consul, except where the legal papers by the competent authorities of the countries that have signed the agreement on judicial assistance with Vietnam;

-Cases filed copy: copy by the competent authorities of Vietnam valid certificate under the provisions of the law of Vietnam about certified copies from the originals;

-Case filed a Vietnamese translation from foreign languages: Vietnamese translation must be certified according to the rules (notary here is understood to be local notary agency or diplomatic representations, consular authorities or other authorized bodies of the foreign certification of the translator's signature as defined by the law) and must submit the attached original or a copy of certificates as specified above;

-Up to the validity of the certificate: validity period must be specified on the certificate and must be valid at the time of evaluation; do not accept employees renew this certificate. The case of this certificate does not specify the validity period, accept the certificate be issued during 24 months from the date of issue.

b) certificate of pharmaceutical products in addition to the provisions in point a of this paragraph must also meet the following provisions:-must have confirmed the drug was allowed to circulate in the country of origin, in the case of drugs not circulating in the country of origin, the company providing the prize must have reasons to drug administration-Ministry of health review;

-The case of the drug produced through many stages in different countries, could not identify the country of origin only, basis of imported drugs must submit the CPP of the country that produced the final form or batch production of CPP. The absence of CPP of both country of origin stated above, drug administration – the Ministry of health will consider accepting CPP of the country in which the product is transported to the importing country;

-The absence of CPP of the aforesaid country of origin, only to accept a drug agency that CPP has the authority of one of the Britain, France, Germany, America, Japan, Australia, Canada or the Agency's evaluation, evaluation of medical products in Europe-EMEA;

-Pharmaceutical management agency authority (according to the WHO list on website http://www.who.int) of the country of origin; granted in the form of WHO apply for quality certification system of pharmaceutical products in circulation in international trade.

c) certificate of circulating freely in addition to meet the provisions in point a of this paragraph must also meet the following provisions:-must have confirmed the drug was allowed to circulate in the country of origin, in the case of drugs not circulating in the country of origin, the company providing the prize must have reasons to drug administration-Ministry of health review;

-By the competent authority in the country of origin, there is sufficient information on the composition, amount, dosage and duration of validity of the certificate.

d) standard certificate in good manufacturing practices, or the paper certification of quality management systems (e.g. ISO 9001 ...) and by the competent authority in the country of origin, has a confirmed name and address of the manufacturer.

Article 5. Rules of establishment orders, languages and forms of records 1. The order of import, export, packaging in direct contact with the drug was 3 a form that suits each kind of medication as prescribed in this circular. Once approved, 2 a save in drug administration-Ministry of health, 1 a sending import business, exporting drugs. A submit import business, export of medicines containing seal "A sending" business procedures at the Customs gate. Order import, export of addictive drugs, mental direction, amount of substance use as drugs including as or coordination that has circulated registration number validity established 2 a.

2. in case of outsourced business import, export drugs, must specify the name of the trust companies import, export of the drug on order.


3. Profile, attached document must be prepared on A4, close up 1 foot for sure. The profile must be arranged in the correct sequence of contents, there are separate between sections. The separator section must be numbered for ease of reference and stamped validation of import business in the first page of each section in the entire record and have the cover note: the import unit name, number, date of establishment, types of orders.

4. The language used in the profile and import drugs: foreign drug imports records are written in Vietnamese or English. Case records are written in English, the information in the instructions for use of medication are written in Vietnamese, except for the following content are allowed to record in other languages have Latin letters root: a root name, miscellaneous) name or common name of drug international;

b) international or common name scientific name of composition, quantitative composition of the medication in case of not translate out Vietnamese or Vietnamese but was not translated means;

c) names and addresses of foreign production, business franchise.

5. For products not imported under the registration number specified in article 11 of this circular, each drug must be established as a separate order, unless smoking has all of the following factors can apply to imports in the same profile: a) the name of the drug;

b) dosage form;

c) recipe for a unit dose (for single dose drug form) or the same amount of concentration (for multi drug dosage);

d) manufacturer;

Article 6. A number of other rules 1. Imported drugs circulating on the market must meet the provisions of paragraph 1 to article 36 of law and pharmacy.

2. imported Drug serves for the project, the program the national health goals, aid, humanitarian aid; drugs imported for the purposes of the clinical trial, do the registration form, to serve the research, testing, testing; imported drugs to participants exhibiting, exhibition fair must be properly used the purpose, the right audience and are not allowed to circulate in the market.

3. Smoking aid by organizations and individuals to the provisions in paragraph 8 of article 3 of this circular import, after receiving the receiving unit must establish the Council to inventory, assess, categorize and enter the repository to manage. Only be allowed to take the drug quality assurance, also expires on use for treatment. For these drugs are not allowed to use, must establish the Council to proceed with the cancellation of the drug in accordance with circular No. 03/2009/TT-BYT dated 28 April 2010 on the management quality, guaranteed not to pollute the environment.

The heads of the unit receiving the drug aid are fully responsible for the quality of medicines, the use of the drug is effective, affordable and safe.

4. Smoking aid, humanitarian aid must ensure the following requirements: a) Must be allowed to circulate in the country. For vaccines, medical products is the serum that contains antibodies to list medical products, vaccines that are health organizations recommended use;

b) must meet the requirements for the right to use the fact of receiving aid and national drug policy of Vietnam;

c) Not in the formulary, the list of ingredients and finished products imported banned drug to make drugs used for people (except in the case of imported drugs serve program, national projects that are approved by Government);

d) must have a clear source and ensure the standard of quality, safe, and effective use in the country and aid Vietnam. Vaccines, biological medical aid must have the vote tested quality standards of national auditing agency country or agency having jurisdiction over the same time, imports must be national testing of vaccines and medical products quality assessment prior to import;

DD) Must be packed in appropriate packaging, have to specify: the name, active ingredient, amount, dosage, packing, instructions to use drugs and have the listing details accompany each packing unit e) special cases, drugs for AIDS research program does not meet the provisions in point a , b, c, d and DD this clause, may consider allowing relaying based on legal documents, technical relevance of the research program.

5. Medicinal herbs used for manufacturing, blending and clear in the drug manufacturing facility, medical facility with Oriental medicine service for the prevention and cure for the quality and standards must be provided by the facility are eligible drug business.

6. radioactive Drugs, in addition to the implementation of the provisions of this circular must comply with the provisions of the law related to the safety of radiation.

Chapter II FORMS the MANAGEMENT of import, EXPORT and the PACKAGING in DIRECT CONTACT with the DRUG article 7. Imported drugs, the packaging in direct contact with the drug 1. Prohibition of import to make drugs used for the finished product and raw material drugs do drugs prescribed in the list of ingredients and finished products imported banned drug to make drugs (Appendix).

2. the registration number issued is valid, except smoking addictive, mental direction and precursors used, are imported according to the need not to suggest the import permit or import order confirmation.

3. Smoking, the packaging in direct contact with the imported drugs must have a permit to import of drug administration, Ministry of health include: a) the mental, addictive Drugs, precursors used, including as or coordination which has the registration number issued is valid;

b) Smoking finished products, raw materials for making drugs, vaccines, biological medical products, yet have the registration number;

c) packaging in direct contact with the drug.

Article 8. The export of drugs, the packaging in direct contact with the drug 1. Addictive drugs, mental direction, amount of substance use as drugs, including as coordinated or when the exporter must have the export licenses of drug administration, Ministry of health.

2. Smoking, the packaging in direct contact with the drug, except drugs prescribed in paragraph 1 of this article when the export unit of export formalities directly with the Customs gate does not need an export license by the Ministry of health.

Chapter III records, IMPORT PROCEDURES, the PACKAGING in DIRECT CONTACT with the drug, DRUG TESTING of IMPORTS section I IMPORT MEDICATIONS. The REGISTRATION NUMBER ISSUED is VALID article 9. Addictive drugs, mental direction and amount of substance use as smoking 1. Profile: a) the import order (form No. 2a, 2b);

b) inventory report addictive drugs (or mental direction, drug precursors used for smoking) (form 3).

2. procedure: send business to Drug Administration – Department of health. Within 15 working days from receipt of valid records, drug administration-Ministry of health license is imported. Case no license, drug administration – the Ministry of health have written business reply and stating the reason.

Article 10. Other medications, except the provisions of article 9 of this circular import business procedures at the Customs gate and present the Customs gate drug import (form 4) accompanied the originals or certified copies of the following documents: valid a) license product circulation or decide the level of circulating registration number; the text allows for changes, additions, other (if any);

b) license to operate about smoking and smoking materials in Vietnam for foreign companies to provide drugs, except the traders specified in point b, c paragraph 12 of article 3 of this circular.

Section II. IMPORTING DRUGS NOT YET HAVE REGISTERED a CIRCULATION of article 11. Drug products containing the substance does not yet have the registration number or substance which has the registration number but not enough to meet the needs of the treatment, the medical products used for prevention, diagnosis, cure 1. The condition and quantity of the drug import license review: made according to the provisions of article 7 decision No 151/2007/QD-TTg dated 12/9/2007 by the Prime Minister issued the regulations on the import of drugs yet to be registered in Vietnam.

2. Profile: a) the import order (model No. 5a, 5b, 5 c, 5 d, 5);

b) certificate of pharmaceutical product. The case does not have a certificate of pharmaceutical product, can be replaced by FSC and GMP. The case has several production facilities involved in the production process, the importing facility must submit drug GMP certification of all production facilities are involved in the process of the production of finished products;

c) standards and methods of quality control of drugs;

d) drug Labels and manual sheet markings of the import business, including: 1 the original label with the original manual sheet of drugs is being circulated in the actual country of origin (except vaccines, health products); 2 the label expected in circulation in Vietnam with manual sheet Vietnamese;

DD) inventory reports for addictive drugs, mental direction and amount of the substance used (form No. 3);

e) profile clinical and clinical money for smoking contains new drug, a new combination of medicines the medicinal substance.

3. procedure: send business to Drug Administration – Department of health. Within 20 working days from receipt of valid records, drug administration-Ministry of health consider the import license. Case no license, drug administration – the Ministry of health have written business reply and stating the reason.

Article 12. Rare drugs, drugs for the hospital's treatment needs in special cases 1. Profile: a) the import order (model No. 6a);

b) s rare drugs, drugs for the hospital's treatment needs in special cases (model No. 6b);

c) the documents specified in point b, c, d, e, and e clause 2 article 11, except for the following cases:-Organization-business standard drugstore chain "good practice pharmacy" GPP needed to import the drug in the formulary rare, imported drugs for the hospital's treatment needs in special cases for sale at the drugstore GPP reached in the system : must have clear reason nờu text not yet provided are records, the original test votes, and commitment to take responsibility for ensuring the quality of imported drugs;


-Import business the drugs in the formulary rare, imported drugs for the hospital's treatment needs in special cases or the active drug, the concentration, amount, dosage has not had the registration number circulating in Vietnam but are recorded in the documentation of acne that does not provide the records specified in paragraph 2 of article 11 of this circular and the vote the original testing of the drug-import lụ, the profile must include: text stating the reasons given are drug-import records, the original batch of test votes and its commitment to guarantee the quality of imported drugs; Reported drug use (demand, the safety, the efficacy of drug treatment).

2. procedure: send business to Drug Administration – Department of health. Within 15 working days from receipt of valid records, drug administration – the Ministry of health see xột import license. The case does not license the drug administration – the Ministry of health have written business reply and stating the reason.

Article 13. Vaccines, medical products according to the needs of special treatment of the treatment facility, the basis of vaccination and examination facility 1. Profile: a) the import order (model No. 7a);

b) s vaccines, biological basis of health vaccination, testing facility (model No. 7b);

d) A company's commitment to deliver on the quality assurance of vaccines, medical products provided to Vietnam (model No. 7 c);

DD) attached documents (if owls) include: certificate of manufacturing GMP standard or the certificate of production base of standard quality management system (ISO) issued by the competent authority (for In Vitro Diagnostic products), the license of vaccine circulation, medical products License, in some other countries where the vaccine, medical products that are registered and circulated. In special cases, the company has not provided enough material or vaccines, medical products do not meet the provisions in points b, c, and d item 2 article 4 of this circular but necessary for use, drug administration-Ministry of health consideration, decision.

2. procedure: send business to Drug Administration – Department of health. Within 15 working days from receipt of valid records, drug administration-Ministry of health review of import license and request Profiler, templates for national testing of vaccines and medical products for vaccines, medical products import in case of need.

The case does not license the drug administration – the Ministry of health have written business reply and stating the reason.

Article 14. Smoking meets the urgent need for prevention of disease, disaster recovery, disaster 1. Profile: import order (form 8);

2. procedure: send business to Drug Administration – Department of health. Within 5 working days from receipt of valid records, drug administration-Ministry of health consider the import license. Case no license, drug administration – the Ministry of health have written business reply and stating the reason.

Article 15. Smoking serves for the program the national health objectives 1. Profile: a) the import order (form 9);

b) text of the competent authority of the importing drugs program serve national health objectives (the case of necessary drug administration-Ministry of health can request the records prescribed in points b, c, d and e clause 2 article 11 of this circular);

c) for vaccines, medical products is the serum containing the antibodies used to prevent disease, cure beyond the papers specified in point a and b of paragraph 1 of this article must be added the following documents:-certificate of the competent authority of the country of export, or allow the vaccine , medical products;

-Certificate of manufacturing GMP standard;

-Slip the standard test the quality of vaccines, the medical products of national auditing authority or other competent authority country for shipments (certified copies of import business);

-Drug testing results on clinical trial results on the safety of people in the field as specified in point b of paragraph 5 article 4 of this circular.

d) for vaccines, medical products imports as a result of winning bid of national or international tenders in Vietnam, the papers prescribed in detail 1, 2 and 3 point c paragraph 1 of this article which are the program see xột when the tender records xột the proposed import profile are not required to have the papers on.

2. procedure: a) of the target program Drugs health must be imported through the corporate trustee has the function to import the drugs directly. On the drug label must have courageous word "Smoking program was not for sale".

b) within 15 working days from receipt of valid records, drug administration – the Ministry of health see xột import license. Case no license, drug administration – the Ministry of health have written business reply and stating the reason.

Article 16. Smoking aid, humanitarian aid 1. Profile: a) The import of suggested base receive aid, humanitarian aid;

b) drug aid, humanitarian aid (form 10);

c) the text of the authorized agency on the basis of the aid received, humanitarian aid;

d) for vaccines, medical products is the serum containing the antibodies used to prevent disease, cure beyond the papers specified in point a, b and c of paragraph 1 of this article must be added the papers specified in 1.2 and 3 points c of paragraph 1 article 15 of this circular.

2. procedure: import base send to the local health department, the new drug-containing drugs case, the new combination of medicines the medicinal substances which circulate, vaccines, biological medical products: base import send to Drug Administration – Department of health. Within 15 working days from receipt of the order, documents, medical or drug administration – the Ministry of health see xột import license. Case no license, the Department of health or drug administration – the Ministry of health has answered text base and nờu clear reasons.

Article 17. Drugs used for the purposes of a clinical trial, make registration form and to serve the research, testing, testing, and research available/bio equivalent made according to the provisions in clause 1, 2, 4 article 9 decision No 151/2007/QD-TTg dated 12/9/2007 the Prime Minister's regulations on the import of drugs yet to be registered in Vietnam.

1. Profile: a) the import order (model No. 11a, 11b, 11 c);

b) outline of the research on clinical drug trial that is the Minister of health approval for importing drugs to clinical trials;

c) outline of the available research, bio-equivalent to that approved in the specialized technical agency by Ministry of health authorized for import to the available research, bio-equivalent;

d) text approved by competent authorities allows for the subject researches have approval or written request by the competent authority of the importing medication to testing, testing;

DD) base case production, research, testing wanted to import medicine to serve the research, testing of the main base to enclose the text of the proposal and pledged to import drugs used only to serve the research, testing of the base.

2. procedure: import facility to send resumes to the Drug Administration – Department of health. Within 15 working days from receipt of the order, documents, drug administration – the Ministry of health see xột import license. Case no license, drug administration – the Ministry of health has answered text base and nờu clear reasons.

Article 18. Smoking to participate in the fair, the exhibition gallery and the temporary import, re-export cases other medications taken as prescribed in paragraph 3 article 9 decision No 151/2007/QD-TTg dated 12/9/2007 the Prime Minister's regulations on the import of drugs yet to be registered in Vietnam and the provisions of article 12 of Decree 12/2006/ND-CP on January 23, 2006 by the Government detailing the trade Enforcement Act of purchase and sale of goods and international dealers buying, selling, processing and transiting goods with foreign húa.

Article 19. Ingredients for medicines, medicinal herbs have not got the registration number in circulation, the packaging in direct contact with the drug 1. Profile: a) the import order (model No. 12a, 12b, 12 c, 12d);

b) A standard of quality and a method of testing raw materials, pharmaceutical chemicals, packaging in direct contact with the drug for the raw materials, packaging and quality standards of testing method of manufacturer or photocopy of the treatise the quality standards of raw material if Pharmacopeia does not apply the standard of quality of the European Pharmacopeia , Uk, us, international, Japan;

c) for medicinal ingredients is addictive drugs, mental direction, doing drugs precursors must submit inventory report (form No. 3).

2. procedure: send business to Drug Administration – Department of health. Within 7 working days from receipt of valid records, drug administration – the Ministry of health see xột import license.

As for the ingredients for the drug's addictive drugs, mental direction, doing drugs, precursors within 15 working days from receipt of valid records, drug administration – the Ministry of health see xột import license.

Case no license, drug administration – the Ministry of health have written business reply and stating the reason.

Article 20. Radioactive drugs 1. For radioactive drugs in case exempt license, report: follow the provisions of article 11 of this circular.

2. for radioactive drugs in case of non-exempt license, report: follow the provisions of article 11 of this circular and the accompanying license for conducting radiation work by the competent authorities to grant direct sales business of radioactive drugs.

Section III. INSPECTION of IMPORTED DRUGS article 21. Vaccines, biological medical is the serum containing the antibodies 1. Profile: a) auditing sample votes sent;

b) summary records and inspection of production batches of the vaccine, medical products imports (copies are stamped by the manufacturer);

c) licence issued by the competent bodies of water in or other equivalent body attached to each shipment type (stamped copies certified by the Director of import business);


d) evidence of the cold chain during transportation of the lụ imports.

e) vaccine, medical products is the serum that contains antibodies to test (the number of samples required for each type of vaccine, medical products).

2. procedure: import business to send resumes to the national testing of vaccines and medical products. Within 7 working days from receipt of sufficient samples and records as required, national testing of vaccines and medical products to answer in writing the quality of vaccines, medical products and animal safety testing of vaccines, health products submit business.

Chapter IV, PROCEDURES for the EXPORT of DRUGS and the PACKAGING in DIRECT CONTACT with the DRUG Article 22. Addictive drugs, mental direction and precursors 1. Profile: a) export (model No. 13a, 13b);

b) text to allow import of the competent authority of the importing country;

c) Smoking addictive form of coordinated products prescribed in clause 2 article 1 of circular No. 10/2009/TT-BYT on 29/4/2010 guide the activities related to the addictive drug; smoking products mental direction, precursor form of coordination provided for in clause 2 article 1 of circular No. 12/2009/TT-BYT on 29/4/2010 Guide to the activities of drug-related mental direction, the precursors used to export to do registration form, fair, exhibition, research is not required to have a profile as specified in point b of paragraph 1 of this article but must have written a clear explanation of reasons and purposes of drug exports export business;

d) for smoking addictive, mental direction and precursors not have registration number: thờm must have a commitment of business done under contract for export and circulation of products not yet are the Ministry of Health issued the registration number.

2. procedure: within 15 working days from receipt of the order, documents, drug administration – the Ministry of health see xột export license. Case no license, drug administration – the Ministry of health have written business reply and stating the reason.

Article 23. Other medications are not addictive drugs, mental direction and precursor used as or in collaboration, the packaging in direct contact with the drug production in the country was granted a certificate of free circulation (FSC) or certificate of pharmaceutical product (CPP) for export. The number of FSC, CPP is granted according to the requirements of the facility.

1. Profile: Single-level proposal FSC or CPP (14);

The case of importing States required the base form by the CPP or the FSC submits that rule, drug administration-Ministry of health might consider FSC level based on the model are required.

2. procedure: a) the procedure to FSC pursuant to article 13 of decision No. 10/2009/QD-TTg on 10/2/2010 Prime Minister's regulations a certificate of free circulation for the goods and products for export and import.

b) export facility smoking do thờm registration profile trader to supply FSC.

c) within 5 working days from receipt of valid records, drug administration-Ministry of health granted the FSC or CPP (model No. 15a, 15b).

Chapter V HANDLE VIOLATION of article 24. Handle violation 1. The business case for export, import or acts arbitrarily fix the records, documents, legal documents of the competent authorities of Vietnam or abroad; use of false or forged seals, signatures or sign of import facility, production facilities and related facilities in the profile of exports, imports of medicines, the drug administration – the Ministry of health has alerted dispatch base and stop receiving, considering the profile of exports, imports of base particular, the following: a) to stop receiving, considering the profile of exports, imports of base within 3 months for the first violation;

b) Stops receiving, considering the profile of exports, imports of base 6 months to 12 months for violations twice in 12 months;

c) depending on the level of violation, drug administration – the Ministry of health will have dispatch send production companies, the company offers smoking and stop receiving, considering drug registration records or stop receiving, considering registration records about smoking and smoking materials of foreign companies in Vietnam.

In addition to the above forms, drug administration-the Health Ministry will publicly offending content on the basis of electronic information page of the Ministry of health; notice to Agency inspectors, customs authorities and other competent authorities to consider, handle under the provisions of the law.

2. Agencies, organizations and individuals violating depending the level will be stopped receiving, reviewing the records to export, import or sanctioned in administrative or prejudice criminal liability under the law.

Chapter VI ENFORCEMENT PROVISIONS article 25. Effective enforcement of this circular are enforceable after 45 days from the date of signing. Abolish circular No. 10/2006/TT-BYT on the 16/05/2006 the Ministry of health guidelines, export and import of drugs and cosmetics; Circular No. 13/1998/TT-BYT on 15/10/1998 of the Ministry of Health instructed the reception, management and use of foreign aid to Vietnam; the regulations on importing vaccines and medical products in circular No. 08/2006/TT-BYT on 13/06/2006 the Ministry of health guidelines, vaccine importers of medical products; chemicals, preparations for destroying insects, bactericide used in household sector and of health and medical equipment.

In the process, if there are difficulties, obstacles and suggest the Unit report on drug administration – the Ministry of health to consider, resolve./.