CIRCULAR guide the export and import of drugs and cosmetics _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Pharmacy pursuant to the law No. 34/2005/QH11 on Jun. 14, 2005;
Pursuant to the law, anti-drug no. 23/2000-QH10 on December 9, 2000;
Pursuant to Decree No. 58/2003/ND-CP on May 29 năm2003 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 Decree No. 49/2003/ND-CP dated 15 May 2003 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
The Health Ministry instructed the export and import of drugs and cosmetics as follows: i. GENERAL PROVISIONS 1. Scope 1.1. This circular to adjust export activities, importing medicines and healing for people (drugs) include: smoking finished products, raw materials for making drugs (drug, Pharmaceutical Excipients, capsule shell, smoking and packaging in direct contact with the drug) and cosmetics have direct impact to human health in the Health Ministry Portfolio Manager (cosmetics).
1.2. The import of the drug product has not had the registration number, make new types of drug use in Vietnam (minus the addictive drug, mental direction, amount of substance use as drugs), the Ministry of health will guide in a separate text.
1.3. Smoking humanitarian aid; drugs, cosmetics import export temporary export, re-re-enter and transfer; the drug import and export by the Africa trade; vaccines are not in the scope of this circular.
2. Subjects of application this circular apply to Vietnam traders; the Organization, the other individual activities related to export, import of drugs and cosmetics.
3. The right to export and import of drugs and cosmetics 3.1. For traders is no Vietnam Enterprise foreign direct investment include: a) the enterprise has the certificate of eligible drug business and standard drug store "good storage practice" (GSP) are imported the drug directly and receive mandated drug imports.
b) for enterprises are made directly imported the drugs before the day this circular effect but no certificate of eligible drug business, yet GSP standard drug inventory is continuing to directly import the drug at the same time must urgently proceed do the procedure to be the Ministry of Health issued a certificate eligible drug business and deploy application good practice guidelines for preservation of smoking by decision No. 19/2005/QD-BYT on 05/7/2005 of the Minister of health about the adjustment plans imposed principles, standards of "good manufacturing practice" attached to decision No 3825/2004/QD-BYT on 03/11/2004 of the Minister of health about the deployment applied principles standard, "good manufacturing practice" as recommended by the World Health Organization and "good practice" storage attached to decision No. 2701/2001/QD-BYT on 29/6/2001 of the Minister of health about the deployment applied the principle of "good practice" storage.
c) drug production business has a standard certificate of "good manufacturing practice" (GMP) are imported drug ingredients to produce its own drugs business.
3.2. for the trader's business for foreign direct investment in Vietnam include: a) enterprises, foreign-invested drug has the certificate of eligible drug business are directly import, import authorization as drugs to produce the drug as prescribed in the investment license.
b) businesses have invested abroad (outside the object prescribed in detail a point 3.2 above) cannot be directly imported and direct drug distribution in Vietnam, only to be imported and distributed the drug through the Vietnam business functions to export, import and distribute drugs (unless otherwise specified by the law of Vietnam).
3.3. export traders, mandated drug exports (minus the addictive drug, mental direction vàtiền the substance used to export must have the export license of the Ministry of health).
3.4. Traders are allowed to import drugs mandate (except for the smoking category prohibited import) according to the scope defined in the certificate of eligible drug business.
3.5. Traders are allowed to export, the import of cosmetics does not depend on the profession of business registration.
3.6. individual organizations are not traders on the basis of the contract to be signed as prescribed by law, be mandated to export/import the drug serve the needs of your own organization, use that individual (except for the smoking category prohibited imports, suspended exports).
3.7. for foreign companies provide drugs imported to Vietnam: a) foreign companies have active licenses on medicines and raw materials for making the drug in Vietnam provided smoking finished products, raw materials for making drugs for the import business of Vietnam according to the range of activities specified in the license.
The case of the rare drugs needed for treatment needs or the raw materials needed for production needs but the company had no license to offer, the Ministry of health will look for imported from reputable companies in the world.
For Pharmaceutical Excipients, capsule shell, smoking, the packaging in direct contact with the drug imports, the foreign company offers are not required to have license to operate about smoking and smoking materials in Vietnam.
b) foreign companies have active licenses on medicines and raw materials for making the drug in Vietnam provided the finished products, raw materials for making the drug has had the registration number of the main production company for the Vietnam business name registration or stand for the import business of free Namcó eligible imported directly under the provisions of this circular.
4. General conditions on the export and import of drugs and cosmetics 4.1. Export, import of addictive drugs, mental direction and precursor drugs used must follow the following rules: a) addictive medication management regulation issued together with decision No. 2033/1999/QD-BYT on 09/7/1999 of the Minister of health and decision No. 1442/2002/QD-BYT on 25/4/2002 of the Minister of health about the addition of some articles of the Statute Addictive drug management issued together with decision No. 2033/1999/QD-BYT on 09/7/1999;
b) Regulations smoking mental direction attached to decision No 3401/2001/QD-BYT on 12/7/2001 and decision No. 1400/2002/QD-BYT on 25/4/2002 of the Minister of health about the amendments and supplements to some articles of the regulations smoking mental direction attached to decision No 3401/2001/QD-BYT on 12/7/2001; Decision No 71/2004/QD-BYT on 09/01/2004 of the Minister of health about the addition of several substances to the list of drugs, mental direction of precursor regulations smoking mental direction attached to decision No 3401/2001/QD-BYT on 12/7/2001;
c) the provisions of this circular and the other provisions of the relevant laws.
4.2. The quality of imported cosmetics, medicine

Traders produce, export or import of medicines, cosmetics; Traders mandate, entrusted to export, the importing of drugs, cosmetics must be responsible for the quality of medicines, cosmetics, import export under the provisions of the law, commercial law, drug quality management regulation attached to decision No. 62/1998/QD-BYT on 15/9/1998 of the Minister of health and the other provisions of the relevant laws.
4.3. Limit use of the drug a) Smoking finished products imported into Vietnam to have the remaining expiration since Vietnam to a minimum of 18 months. For limited use by or under 24, the term used is left to the port since Vietnam is minimum 12 months. Special cases, the Health Ministry considered specific resolution.
b) imported raw materials to produce the drug must also limit use on 3 years from the date to the port of Vietnam, for limited user material 3 years or under 3 years then the day arrived Vietnam not too 6 months from production date. This Regulation shall not apply to medicinal herbs.
4.4. original test Voucher When making customs, the import business of drugs, cosmetics must present the Customs gate testing voucher of the original manufacturer quality standard certification for each batch of drugs or imported cosmetics. The Customs gate only keep copies of original test votes have stamped confirmation of import business.
4.5. the intellectual property rights of medication, imported cosmetics traders produce, export or import of medicines, cosmetics; Traders mandate, entrusted to export, the importing of drugs, cosmetics are responsible for intellectual ownership of drugs, cosmetics, produced for export, import and export, import of trustee.
4.6. Setting the order and record exports, importing the drug and cosmetics was established as 3 a form specified in this circular (for smoking addictive products, mental direction, precursors used the medicine yet has the registration number imported, each drug is established as a separate order). Once approved, 2 a saved in Vietnam drug administration, 1 a send business. A send business stamp "A send business" to the gate when the customs clearance procedures.
Records, documents accompanying the order to close the sure, have the cover note: the import unit name, number, date of establishment, types of orders.
4.7. the drug Label, cosmetics export, import.
Comply with the provisions of the regulations labelling goods circulating in the country and exports, imports are attached to decision No 182/1999/QD-TTg dated 30/8/1999 of the Prime Minister, decision No 95/2000/QD-TTg dated 15/8/2000 of the Prime Minister about the adjustment , added some content of labeling regulation domestic goods and exports, imports are attached to decision No 182/1999/QD-TTg dated 30/8/1999 of the Prime, circular No. 14/2001/TT-BYT on 26/6/2001 of the Ministry of health drug labeling guidelines and cosmetics directly impact to human health and the law other related.
Printing or labelling of imported drugs for extra-circulating in Vietnam are made as follows: a) the label of the drug manufacturer can be printed directly or paste on the outer packaging of the drug.
b) where the manufacturer has not yet printed or labelled on the packaging side of drugs, the drugs must be entered on the repository of the import business to make printed or labelled before side introduced.
The case of the trader-mandated import then make prints or extra labeling in the warehouse of the importer or trader mandated imports.
c) extra Label not obscure information on the external packaging of the drug and to make sure the contents are as follows:-for the drug has had the registration number on the import side, the label must show full content: full name, address (city, province) of the import business and Commission Merchants importing (if available).
Example 1: DNNK: name of importer, TNUTNK address: NK, trustee business name address (if available): the pharmaceutical company DNNK Cananga, TNUTNK: DP Ltd. Hanoi, Ha Tay-Bias against smoking addictive, mental direction, precursors used the medicine yet has the registration number on the import side, the label must show enough of the content : the full name, address (city, province) of the import business and traders imported trustee (if any); the number and the date, month and year of import licensing.
Example 2: DNNK: import business name, address of GPNK: ... ... ../QLD-.. ... day.../.../200 ...

TNUTNK: name of business trustee (if any) NK DNNK:-metals, pharmaceutical company Hanoi GPNK number: 389/QLD-KD 30/4/2004 TNUTNK: DP Ltd. AB, peace 4.8. Paying the drug a) drugs-import business with respect to medication had not yet registered importers, import business depending on the form of the wholesale business, retail for each imported item must include orders import table declaration of the price of imported drugs, including: Vietnam to import price (CIF price not including input tax); wholesale price in Vietnam, the expected retail price in Vietnam (model No. 1). Drug prices have to be declared under Vietnam money (USD) for the smallest packaging unit.
-For the drug product had registered, when price changes compared to the prices declared when registering, the importer must declare to the Department of health under the rules.
b) Commission Merchants importing the drug Must provide full and accurate information on drug prices of foreign partners (foreign producers or exporters) to import business mandate.
4.9. Monthly report import business to report the Ministry of health (Vietnam drug administration, financial planning) import-export situation of the previous month (model No.: 2a, 2b, 2 c, 2d, 2e). Time of filing reports before July 10.
4.10. Fees and charges drug import business, cosmetics have to file charges and fees as prescribed by the law.
4.11. The term of validity of import licenses import licenses are worth a maximum of 1 year from the date of signing.
II. List And FORM MANAGER EXPORT, Import Of MEDICINES, Cosmetics 1. 1.1 drug exports. Addictive drugs, mental direction and amount of the substance used (Appendix 1) export must have the export license of the Ministry of health.
1.2. The export of drugs (except drugs prescribed in point 1.1 above) made at the Customs according to the current rules. The case of the importing country requires an export license, the Department of health will issue export licenses under the proposal of the business.
2. Export and import of cosmetics 2.1. The export of products made at the Customs according to the current rules. In the case of the importing country requires an export license, the Department of health will issue export licenses under the proposal of the business.
2.2. Cosmetic direct impact to human health were the Ministry of Health issued the registration number in circulation are imported according to the needs.
3. Import the medication 3.1. Raw materials and finished products banned imports: Appendix No. 2.
3.2. import Drugs the needs not to confirm the order import: include the smoking finished products, raw materials (except smoking addictive, mental direction and precursors used for smoking) have a valid registration number. Specific category by the Vietnam pharmaceutical Management Bureau announced by each stage.
3.3. imported Drugs must have imported license of Ministry of health: a) Smoking addictive products, mental direction, precursors has had the registration number or the registration number yet as or coordination.

b) raw materials has had the registration number is smoking addictive, mental direction, precursor used as drugs.
c) raw materials do not have drug registration number (including the material is smoking addictive, mental direction, precursors used for smoking).
III. Records, IMPORT PROCEDURES And DRUGS 1. Importing the drug has circulated registration number validity 1.1. Addictive drugs, mental direction and amount of the substance used to make the drug import business established orders suggest that the import license (model No. 3a, 3b, 8 d) inventory report (form 4).
Within 7 working days from receipt of the order, documents, the Ministry of health license is imported. In case no license must have written business reply stating the reason.
1.2. Other medications (except drugs prescribed in point 1.1 above) import business procedures at the Customs gate and the gate customs orders (5) accompanied by the following documents:-circulation products or licence decision granted the registration number in circulation; the text allows for changes, additions, other (if any).
-Permit the operation of drugs and drug ingredients in Vietnam by foreign companies providing the drug.
2. Imported products addictive drugs, mental direction and precursors used the medicine yet has a circulation of 2.1 registration number. Ministry of health conditions to consider licensing of imports when they meet one of the following conditions: a the drug-containing Drugs) the Group pharmacological effects or dosage form containing at least the registration number circulating in Vietnam on drug registration number issued by the Vietnam pharmaceutical Management Bureau announced under each stage;
b) medication contains substance not yet have registered in Vietnam:-substance previously had the registration number circulating in Vietnam but at the time of submission of import, circulation registration expired or not registered;
-The substance has been released in countries all over the world but never registered in Vietnam, except for the new drug;
c) rare specialty drugs, Medication, treatment, medication dosage especially to meet the needs of the treatment;
d) Drugs have technology transfer contracts, production has filed registration documents and are waiting to grant the registration number;
e) import Drugs the needs particular treatment of the Hospital (the hospital's planned according to the model regulations and the Hospital Director's commitment) is provided only for the hospital as planned.
f) production businesses have foreign direct investment be considered licensed importers for marketing during manufacture in accordance with the Ministry of Commerce and the Ministry of health.
2.2. import profiles import business established orders suggest that the import permit (Form 6) accompanied by the relevant documents submitted to the Ministry of health (the Vietnam pharmaceutical Management Bureau). The records include: a) the certificate of pharmaceutical product (CPP) according to the system of quality certification of the World Health Organization by the competent bodies of water in the level. The case does not have a certificate of pharmaceutical product, could be replaced by free sales certificates (FSC) of the product and the certificate of good manufacturing practices (GMP) of the factory due to the State agency authorized countries.
The certificate must be originals or copies certified in Vietnam or in the country.
b) standards and methods of quality control of drugs.
c) 2 sets of sample labels (including: addition label, label, label directly) and manual sheet markings of the import business, in particular:-the form of the original labels of the drug are circulating in the country. The case of the language on the form of the original labels of the drug is not English or French, must be submitted with the form designer label to imported into Vietnam with the language on the form labels are translated to English or Vietnamese.
-Manual Sheet (1 original, 1 copy by South Vietnamese). For the drug from medicinal herbs, Oriental medicine, manual medicine use by South Vietnamese must complete the components of the drug, the drug name is recorded by South Vietnamese and Latin.
d) paying the Table of imported drugs (model No. 1).
e) inventory report (form 4).
f) for the substance has been released in countries all over the world but never registered in Vietnam to submit additional records of pharmacological effects and clinical research.
g) for importing drugs under the specific needs of the hospital:-established as separate orders (Form 6) and specify import order according to the specific needs of the hospital.
-Provision of hospital (model No. 7).
-Certificate of commitment by the Director of the hospital is the only drug used in hospital according to the plan.
-The profile specified in a, b, c, d, e, f point 2.2 above. In special cases, the disease việncần set using the active drug, the concentration, amount, dosage has not had the registration number circulating in Vietnam but has been noted in the documentation that the importer did not provide the records specified in properties a, b, c , d, e, f point 2.2 above must be filed with the following: + the text of the proposed business to serve the needs of a particular treatment, why not provide the profile of import drugs as prescribed, is committed to the quality of imported drugs.
+ Report use of drugs (needs, safety, effective treatment of the drug) and the commitment of the Director responsible for the reception, rational drug use, safe.
2.3. licensing procedure within 20 working days from receipt of the order, documents, the Department of health to review the import license. In case no license must have written business reply stating the reason.
3. Import the raw materials do not have medication registered a circulation of 3.1. Import profiles import business established the order of import licensing proposal accompanied by the relevant documents submitted to Ministry of health (the Vietnam pharmaceutical Management Bureau). The records include: a) the import order (model No. 8a, 8b, 8 c, 8 d) b) quality standards and testing methods of raw materials for the raw materials of quality standards and testing methods of the manufacturer stamped confirmation of import business. This provision is not mandatory for medicinal herbs.
c) for medicinal ingredients is addictive drugs, mental direction, precursor to submit inventory reports (form 4) 3.2. Licensing procedures within 7 working days from receipt of the order, documents, the Department of health to review the import license. Cases not permit to be writing business reply stating the reason.
4. Imports of drugs and cosmetics in the case of the other special 4.1. Importing the drug for prevention, disaster records include: a) the import order (model No. 9).
b) text proposed by the import business of importing drugs serves prevention, disaster certified by the State Management Agency on health.
4.2. Importing the drug of the program, the national health project profile include: a) the import order (form 10).
b) profile attached: legal documents relating to the import of medicine programs and national health projects.
c) of programs, national health projects must be imported through the trustee business for drug import functionality directly. On drug labels must contain the words "Smoking national health program" or "national health" project.
4.3. Imports of medicines, cosmetics registration form circulation records include: a) the import orders: (model No. 11a, 11b).

b) Each finished drugs, cosmetic products to be imported not more than 10 units Pack fit the intended model introduced.
c) imported drug ingredients 1 package, each package volume enough for 3 times the test match each type of raw material.
4.4. Imports of the drug for testing, manufacturing research profile include: a) the import order (model No. 12).
b) the Department of health will consider specific with the amount appropriated for the purpose of import.
IV. Record, EXPORT PROCEDURES And DRUGS 1. Addictive drug exports, mental direction and amount of substance use as a drug: 1.1. Addictive drugs, mental direction and precursors are used as registration number or co-ordination of records including: a) export (13).
b) text to allow import of the competent authority of the importing country.
1.2. addictive Drugs, mental direction and precursors are not used as registration number or co-ordination of records including: a) export (13).
b) text to allow import of the competent authority of the importing country.
c) A pledge of the enterprise made under contract for export and circulation of products not yet are the Ministry of Health issued the registration number. Corporate Directors are responsible for the quality and intellectual property rights for medicines for export.
2. Other medications (except smoking addictive, mental direction and precursors used for smoking) and the export of products made at the Customs according to the current rules. In the case of imported water requirements and the proposal of business to export, the export of drugs, cosmetics as follows: 2.1 export is a drug) export list (form 14).
b) submit profile defined in detail c, point 1.2, section 1 of part IV of this circular.
2.2. Export of cosmetics.
Export orders (15).
3. licensing procedure: within 7 working days from receipt of the order, the valid profile, the Health Ministry will issue export licenses under the proposal of the business. No case export license must have text answers and stating the reason.
V. IMPLEMENTATION And HANDLE BREACH 1. Vietnam Pharmaceutical Management Bureau in the range, the authority receiving record, verify and the import permit, export permit smoking, cosmetics.
2. Inspection of the Ministry of health in collaboration with the Service, the Bureau of the Ministry of health functions checked, inspected, processed according to the provisions of the law for the breach of drug prices and import-export activities, cosmetic medicine in nationwide.
3. the Health Department inspectors, city centrally responsible for inspecting, inspections and processed in breach of drug prices and import-export activities, cosmetic medicine in the province, the city.
4. Enterprises participated in export activities, the import of medicines, cosmetics in violation of the provisions of this circular, then depending on the degree of offense that the sanctioned administrative offense or the Health Ministry considered stopping the export permit, import during the period from 6 months to 1 year or arrested save for criminal liability in accordance with the law If damage compensation according to the provisions of the relevant laws.
VI. ENFORCEMENT Of TERMS 1. The single drug imports and raw materials do not have drug registration number has been Ministry of health (the Vietnam pharmaceutical Management Bureau) the import license since 01/01/2006 has validity until 30/4/2006 was extended until 30 September 2006.
2. The categories are import registration number has been Ministry of health (the Vietnam pharmaceutical Management Bureau) to confirm in time from 01/01/2006 to 30/4/2006và in force to 30/4/2006 was extended as follows:-to extend until 30 September 2006 for the duration of the registration number following on 30/9/2006.
-Extend to effect the registration number for the duration of the registration number in the time from the date of this circular in force until 30 September 2006.
3. This circular have effect after 15 days from the date The report and repealed the previous provisions contrary to the provisions of this circular.
4. Vietnam pharmaceutical Management Bureau, Ministry of health, the Health Department of the province, central cities, Vietnam Pharmaceutical Corporation, the exporters, importers of drugs, cosmetics, foreign companies have active licenses in the field of medicine, the treatment facility drug testing facility, is responsible for implementation of this circular.
In the process, if there are difficulties and obstacles the vịbáo proposal report on the Ministry of health (the Vietnam pharmaceutical Management Bureau) to consider and resolve.