Circular of the Ministry of health no. 05/2004/TT-BYT dated 28 May 2004 drug production guide _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to the law to protect people's health on July 11, 1989 and regulations smoking prevention, healing attached to Decree No. 23 dated January 24, 1991 of the Council of Ministers (Government);
Bases of the Civil Code of the Socialist Republic of Vietnam in 1995;
Pursuant to the law of trade;
Pursuant to Decree No. 58/1998/ND-CP dated July 31, 1998 of Government: Law enforcement detailed regulations of trade on exportation, importation, processing and purchasing agents of foreign goods; Pursuant to Decree No. 44/2001/ND-CP on 02/08/2001 of the Government on the amendments and supplements to some articles of Decree No. 58/1998/ND-CP dated July 31, 1998 of Government: law enforcement detailed regulations of trade on exportation, importation, processing and purchasing agents of foreign goods;
To make use of the production capacity of domestic enterprises, enhance production and improve the quality of drugs circulating in Vietnam, better satisfying the needs of medicines, the Ministry of health produced guidelines, as follows: i. GENERAL PROVISIONS 1. Application object and scope 1.1. Applicable objects:-organizations, enterprises, individual pharmaceutical manufacturing, pharmaceutical research center, Institute legal under the provisions of the law of Vietnam.
-Foreign manufacturers have the license to operate in the field of pharmacy in Vietnam 1.2. Adjustment range:-production activity of the drug are registered in Vietnam (except for smoking contains the active ingredient, dosage is in the category do not receive new registration records and registration for foreign pharmacies are the Ministry of Health issued).
-Production activity of the drugs has not had the registration number circulating in Vietnam: for foreign drugs, on the latest tools to get back the whole product after processing; For the drug in the country, on the latest tools to export all products after machining.
2. Explanation of terms In this circular, the terms below are interpreted as follows: 2.1. Drug production is taking a producer (the party most recent work) are in possession of a drug (have or have not had the registration number of the registration in Vietnam) put a machining other manufacturers in Vietnam (the receiving Party outsource) to produce the drug. The receiving party return machining of finished products to the latest tools to grab a funds the production was agreed upon in the contract.
2.2. the party most recent work is the drug manufacturers are in possession of most recent work.
2.3. the receiving Party is party to conduct production and receive public money from the production side of the latest machining.
2.4. production in this circular is meant to be: * for foreign drugs: whole machining-the stages of the production process and can only be set at a party.
-A processing stage of the production process and can only be set at a party getting tools applied to the particular form that Vietnam has not produced: powders for injection, the slow effect, freeing controlled active substances, drugs, dosage especially for children.
* For drug production in the country put a machining or all stages of the production process and can only be set at a party.
3. registered number of drug circulation Level production 3.1. Smoking puts the entire machining stages of the production process will be granted registered production and allowed to circulate in Vietnam. The registration number of the drugs production to maximum effect for 5 years from the date of grant of the validity of the old registration number will terminate immediately after registration of the production work force.
3.2. Smoking put a machining stages of the production process to be continued under the old registration number has been issued and must submit registration documents according to the instructions in this circular.
3.3. Export and import of drugs production follow the regulations in the law Commercial Law enforcement manual on export and import operations, outsourcing and purchasing agents of foreign goods; The regulations of the Ministry of health on drug import and export management each period and the other legal texts concerned.
II. REGULATIONS For The PARTY SET To PRODUCE The DRUG 1. Conditions to be named Party place: the facilities here are standing as the party name latest offshoring: 1.1. Drug manufacturing facility of Vietnam have the drug granted the registration number is valid or not have the registration number in the country of export to Vietnam.
1.2. Foreign drug makers have "active license of foreign enterprises about smoking and smoking materials in Vietnam" drug processing were Vietnam Ministry of Health issued the registration number issued is valid or not have the registration number circulating in Vietnam that set the Party will get back the entire machining products.
1.3. The Institute, a research center there was the Health Ministry-level research registration number in circulation.
2. Responsibility of the Parties placed 2.1 machining. Responsible for registering medicines with the Vietnam pharmaceutical Management Bureau.
2.2. Provide materials in the correct quantity, quality, duration, venue for the receiving Party, or provide material to the standard under which the receiving Party supply order processing in the drug production process.
2.3. Supply processes, technical standards and testing methods of initial raw materials, semi-finished and finished products, other papers relating to the production of drugs.
2.4. the retention of the records, documents relating to the distribution process, ensuring the quality of drugs circulating on the market.
2.5. Is responsible for the quality, safety, effectiveness of drugs for consumers in the process of circulation of medicines on the market.
2.6. Is responsible for the intellectual property puts drug production.
3. Rights of the party put 3.1 machining. Number of registered and owned products.
3.2. product is received according to the machining methods, time limits and conditions agreed.
3.3. Is the right to refuse to receive the product machining non-standard quality as signed in the contract.
III. RULES For DRUG PRODUCTION RECEIVER 1. Conditions for the receiving Party's name.
Is the production base was Vietnam Pharmaceutical Management Bureau certificate of good manufacturing practice (GMP) match the intended drug production.
2. The responsibility of the receiving Party work 2.1. Proceed to produce the drug in accordance with the procedures, techniques and quality assurance of medicines according to the registration documents and the requirements of the most recent work is regulated in the contract was signed.
2.2. If the party receiving the free machining material supply at first, they must ensure the quality of raw materials according to the standards of the party place.
2.3. The latest machining provides manufacturing process, technical standards and testing methods of initial raw materials, semi-finished and finished products, other papers relating to the production of drugs.
2.4. Retention of records, documents, samples of drugs related to the drug production process.
2.5. Is responsible for product quality control throughout the production process and ensure the quality of the product to pay the party set.
2.6. Return the product, raw materials, scrap, scrap for the parties to put completed after the machining processing contract as required.
3. the receiving party rights tools 3.1. Received public money under the agreement.
3.2. Is entitled to request the party to put his public affairs materials in the right quantity, quality, duration, location as agreed in the contract.

3.3. Is the right to refuse to receive production if the most recent work provides the raw material does not meet the quality standards as signed in the contract.
IV. CONTRACT WORK-SMOKING drug production contract to do the text and must follow the rules of the law of Vietnam related to outsourcing contracts, in addition to have the following content: 1. Agreement on the supply of raw materials , providing production processes, technical standards and testing methods of initial raw material, semi-finished products, finished products and other papers relating to the production of drugs.
2. Rights and responsibilities of each party regarding the quality control of raw materials, semi-finished products, finished products, packing process, the label of the product and specify the signing slip testing each batch of finished products and marketed products.
3. Powers and responsibilities of each party regarding the retention of records records of production, quality control, distribution, circulation, saving the form, solve the problems related to the quality, appeal, revoke the product on the market.
4. process, testing procedures of production machining.
5. in The case of cancellation of the contract.
V. REGISTRATION Of DRUGS PRODUCTION 1. General instructions 1.1. Drug registration records production must do three sets, including a Ministry is a key. The following documents without a principal must have a copy:-circulation permit smoking (FSC)-standard certificate of good manufacturing practices (GMP) or replace the two licenses on by certificate of pharmaceutical product (CPP) also have additional 2 the main drug label accompanies drug registration records. The records must be clearly printed on A4 size paper, arranged in the correct sequence, are divided between the sections.
1.2. All the documents in the record must be set Side machining confirmation (signature, stamp), the case of the pharmaceutical drug label stickers on A4 paper is stamped onto the drug label.
1.3. drug registration records are written in Vietnamese. Name the components of the drug in the profile have to be the original name or the name in common usage in the country. For medicinal herbs medicinal name must accompany the scientific name in Latin.
1.4. drug Label, the directions for use of drugs: done properly the regulations about labeling guidelines and trademark of the drug. On the outer packaging label and leaflet are inscription: "made in: (name of party work) under contract to: (name of Party Records latest offshoring)" with font size equal. Print labels on the jars (the tube), sweaters (tube) oral solution contains an area of label is too small, then lets just print the name of the receiving Party.
1.5. drug registration documents filed in Vietnam Drug Administration to assess and issue registration numbers. Drug Administration reply slow results for no more than 30 days from the date of receipt of a valid application.
1.6. The basis of drug registration must pay a registration fee according to the drug regulations.
1.7. In the time of registration is still in force, if the two sides terminated the contract, on the latest tools to report on Vietnam Drug Administration to withdraw the registration number issued for drugs production.
2. Application 2.1 machining manufacturing drugs. The registration records of drug production base in the country, the Institute, the Research Center put drug production are registered in Vietnam:-cover (model number 1-ĐKT-SXGC).
-Index profile (model No. 2-ĐKT-SXGC)-the registration form (form No. 3A-ĐKT-SXGC) (In the application form must clearly indicate the production).
-Label drug is tied up Model number 4-ĐKT-SXGC (on the label, the guide must write the full name of the manufacturer involved in the stages of the production process).
-Slip the drug testing at the receiving Side.
-Drug Form: 01 template for a specification package subscription.
-Contract work-smoking meets the content as specified in this circular.
2.2. Registration documents of foreign manufacturers put drug production are registered in Vietnam:-cover (model number 1-ĐKT-SXGC).
-Index profile (model No. 2-ĐKT-SXGC)-the registration form (form No. 3B-ĐKT-SXGC) (In the application form must clearly indicate the production).
-Label drug is tied up Model number 4-ĐKT-SXGC (on the label, the guide must write the full name of the manufacturer involved in the stages of the production process).
-Slip the drug testing at the receiving Side.
-Drug Form: 01 template for a specification package subscription.
-Certificate of GMP, drug circulation license (FSC) or replace the two licenses on by certificate of pharmaceutical product (CPP) of registered products production by the competent authority granting validity (for smoking).
-Contract work-smoking meets the content as qui nail of this circular.
2.3. Registration documents had yet registered in Vietnam production base in the country's latest tools to exporters, foreign producers put processing and get back the entire outsourcing products:-cover (model number 1-ĐKT-SXGC).
-Index profile (model No. 2-ĐKT-SXGC).
-Registration form (form No. 3A-ĐKT-SXGC or model No. 3B-ĐKT-SXGC). (In the application form must clearly indicate the production).
-Label drug is tied up Model number 4-ĐKT-SXGC (on the label, the guide must write the full name of the manufacturer involved in the stages of the production process).
-Certificate of GMP, drug circulation license (FSC) or replace the two licenses on by certificate of pharmaceutical product (CPP) of registered products production by the competent authority granting validity (for smoking).
-Specifications and test methods of smoking by the side of the most recent work provides.
-The process of producing the drug due to Side most recent work provides.
-Slip the drug testing at the receiving Side.
-Drug Form: 01 template for a specification package subscription.
-Contract work-smoking meets the content as specified in this circular.
-Drug commitment Sheet contract manufacturing outsourcing not consumed in Vietnam.
VI. Test, Inspection And HANDLING VIOLATION 1. Check-1.1 Inspector. Vietnam Pharmaceutical Management Bureau, in collaboration with the Ministry of health, the Inspection Service, Bureau function to inspect, inspect the implementation of this circular in respect of the production units, pharmaceutical business in the country.
1.2. the Department of health, the central cities is responsible for checking, inspection of the implementation of this circular in respect of the production units, pharmaceutical business in the local range management.
2. Handle violation of organization, individuals violating the regulations of this circular, the regulations relating to the production, circulation, and the other provisions of the relevant legislation, depending on the level of violation will be dealt with as required by law.
VII. ENFORCEMENT Of TERMS 1. This circular effect after 15 days from the Post Gazette. The previous provisions contrary to the content of this circular are repealed.
2. Vietnam Pharmaceutical Management Bureau, Ministry of health, the Health Department of the province, central cities, Vietnam Pharmaceutical Corporation, the pharmaceutical business, the foreign company has the license to operate in the field of pharmacy is responsible for implementation of this circular.
3. in the implementation process if what obstacles the Unit reports to the Ministry of health (Vietnam Drug Administration) to consider settlement as appropriate.