Thông tư 06/2004/TT-BYT

CIRCULAR

OF MINISTRY OF HEALTH NO.06/2004/TT-BYT DATED MAY 28, 2004 GUIDING THE OUTSOURCING PRODUCTION OF DRUGS

Pursuant to the Law on Protection of People's Health dated July 11, 1989 and the Charter of drugs of medical prevention and treatment issued together with the Decree No.23/HDBT dated 24/01/1991 of the Council of Ministers (now as the Government );

Pursuant to the Civil Code of the Socialist Republic of Vietnam in 1995;

Pursuant to the Commercial Law;

Pursuant to the Decree No.57/1998/ND-CP dated 31/07/1998 of the Government detailing the implementation of the Commercial Law regarding goods export, import, outsourcing and agents of purchase and sale of goods with foreign parties; Pursuant to the Decree No.44/2001/ND-CP dated 02/08/2001 of the Government amending and supplementing some Articles of the Decree No.57/1998/ND-CP dated 31/07/1998 of the Government: detailing the implementation of the Commercial Law regarding goods export, import, outsourcing and agents of purchase and sale of goods with foreign parties;

To take advantage of drugs production capacity of domestic enterprises, strengthen production cooperation and improve the quality of drugs circulating in Vietnam, better satisfy the needs of the people's drugs, the Ministry of Health guides the outsourcing production of drugs as follows:

I. GENERAL PROVISIONS

1. Subjects of application and scope of governing

1.1. Subjects of application:

- Organizations, enterprises and individuals that produce pharmaceuticals, Legal Institute, Center of Pharmaceutical Research under the provisions of the laws of Vietnam.

- Foreign manufacturers with licenses operating in the pharmaceuticals field in Vietnam

1.2. Scope of governing:

- The outsourcing production of the drugs having registration numbers for circulation in Vietnam (except for the drug with active ingredients, dosage forms on the list not receiving new registration and re-registration dossiers for foreign drugs issued by the Health Ministry).

- The outsourcing production of the drugs without registration numbers for circulation in Vietnam: For foreign drugs, outsourcing ordering party must take back all products after being processed; for domestic drugs, outsourcing ordering party must export all products after outsourcing.

2. Interpretation of terms

In this Circular, the following terms are construed as follows:

2.1. Drug outsourcing production means a manufacturer (outsourcing ordering party) owning some drugs (with or without registration numbers in Vietnam) outsources another manufacturer in Vietnam (outsourcing taking party) to manufacture those drugs. The outsourcing taking party shall return the finished products to the outsourcing ordering party to take an amount of remuneration as agreed in the contract.

2.2. Outsourcing ordering party means the drug manufacturer owning drugs ordered for outsourcing.

2.3. Outsourcing taking party means the party conducting the production and receiving money of remuneration from the outsourcing ordering party.

2.4. Production in this Circular shall be construed:

* For foreign drugs:

- Outsourcing all of the stages of the production process and are only be ordered at an outsourcing taking party.

- Outsourcing a stage of the production process and can only be ordered at an outsourcing taking party applied to the particular dosage forms that Vietnam has not been produced yet: lyophilized powder for injection, drug of slow effect, drug releasing its active substance controlled, placing drug, special dosage forms used for children.

* For domestically-produced drug outsourcing one or all of the stages of the production process and can only be ordered at an outsourcing taking party.

3. Grant of registration numbers for circulation of drugs outsourced

3.1. Drug ordered for outsourcing all of the stages of the production process will be granted registration numbers for outsourcing, and allowed to circulate in Vietnam. The registration numbers of the drugs produced by outsourcing takes effect over 05 years from the date of issue, the validity of former registration numbers will be terminated immediately after the registration numbers of the drugs produced by outsourcing takes effect.

3.2. Drug ordered for outsourcing one stage of the production process is continued for production under the former registration number which has been issued and must submit registration dossier as guided in this Circular.

3.3. Import and Export of drugs produced by outsourcing shall comply with the provisions in the legal documents guiding the implementation of the Commercial Law regarding goods export, import, outsourcing and agents of purchase and sale of goods with foreign parties; The current regulations of the Ministry of Health on the management of import and export of drugs from time to time and other concerned legal documents.

II. PROVISIONS FOR OUTSOURCING ORDERING PARTY OF DRUGS PRODUCTION

1. Conditions to be named the outsourcing ordering party:

The following facilities are named in the outsourcing ordering party:

1.1. Lawful drug production facilities in Vietnam having drugs granted valid registration numbers or drugs having no registration numbers for circulation in Vietnam receive outsourcing for export.

1.2. Foreign drug manufacturers having "operation license of foreign enterprises in medicines and medicine materials in Vietnam," order outsourcing drugs granted valid registration numbers for circulation by the Ministry of Health of Vietnam or drugs having no registration numbers for circulation in Vietnam, but outsourcing ordering party will get the entire products.

1.3. Institute, Center of research having drugs granted valid registration numbers for circulation by the Ministry of Health.

2. Responsibility of the outsourcing ordering party

2.1. To register drugs with the Drug Administration of Vietnam.

2.2. To provide materials in accordance with the correct quantity, quality, duration, location for the outsourcing taking party, or provide standards of materials in which the outsourcing taking party themselves supply during the drug manufacturing process.

2.3. To provide manufacturing process, technical standards and testing methods of initial materials, semi-finished and finished products, and other papers relating to drug outsourcing production.

2.4. To keep records and documents related to the distribution process to ensure quality of drugs circulating in the market.

2.5. To be responsible for the quality, safety and efficacy of drugs to consumers in the process of distribution of drugs on the market.

2.6. To be responsible for intellectual property for drugs ordered for outsourcing production.

3. The right of the outsourcing ordering party

3.1. To be owned registration numbers and its products.

3.2. To be received the processed products in accordance with the correct method, terms and conditions agreed upon.

3.3. To be refused to get outsourced products not meeting quality standards as stated in the signed contract.

III. REGULATIONS FOR OUTSOURCING TAKING PARTY OF DRUGS PRODUCTION

1. Conditions to be named as outsourcing taking party.

To be the production facilities issued certificate of Good Manufacturing Practice (GMP) by the Vietnam Drug Administration in accordance with the drugs intended for outsourcing production.

2. Responsibilities of outsourcing taking party

2.1. To conduct drug manufacturing according to the right process, technique and ensure quality of drugs in accordance with records of drug registration and requirements of the outsourcing ordering party specified in the signed contract.

2.2. If the outsourcing taking party self-supplies the original materials, it must ensure the quality of raw materials according to the standards of the outsourcing ordering party.

2.3. To request outsourcing ordering party to provide the manufacturing process, technical standards and methods for testing the initial materials, semi-finished and finished products, and other papers relating to drug outsourcing production.

2.4. To maintain records, documents, drug samples related to drug manufacturing process.

2.5. To be responsible for product quality control during the manufacturing and ensure quality of the products until handing over them to the outsourcing ordering party.

2.6. To return outsourced products, surplus materials, scrap, defective products to the outsourcing ordering party after completion of outsourcing contract as prescribed.

3. The rights of the outsourcing taking party

3.1. To be received remuneration in accordance with the agreement.

3.2. To be requested the outsourcing ordering party to hand over materials according to the right quantity, quality, time limit and location as agreed in the contract.

3.3. To be entitled to refuse to accept outsourcing production if the outsourcing ordering party supplies raw materials not meeting quality standards as stated in the signed contract.

IV. CONTRACT FOR DRUG OUTSOURCING PRODUCTION

Contract for drug outsourcing production must be made in writing and shall comply with the current provisions of the law of Vietnam relating to contracts, in addition, it must contain the following contents:

1. Agreement for supply of raw materials, the supply of production process, technical standards and testing methods of the initial materials, semi-finished products, finished products and other papers relating to the manufacturing, outsourcing of drugs.

2. Rights and responsibilities of each party on the quality control of raw materials, semi-finished products, finished products and packaging process, product labels and clear rules for signature of testing slip for each batch of finished products and manufacture slips of products.

3. Rights and responsibilities of each party on the archives of records on production, quality control, distribution and circulation of drugs, the storage of drug samples, settlement of problems related to quality and complaints, recall of products on the market.

4. Process and procedures for inspection of the production facilities of the outsourcing taking party.

5. The cases of contract cancellation.

V. REGISTRATION OF DRUGS PRODUCED BY OUTSOURCING

1. General Guidelines

1.1. Registration dossier of drug produced by outsourcing must be made in 3 sets, including one original set. The following documents without the originals, they must have a notarized copy:

- Permit for the sale of drugs (FSC)

- Certificate of satisfaction of standards of good manufacturing practice (GMP) or replaced two above licenses by a certificate of pharmaceutical products (CPP).

Besides, it is also required to have two more 02 original sets of drugs label accompanied with the drug registration dossier. Dossier shall be printed on A4 size paper and arranged in the correct order, with separates between the parts.

1.2. All documents in the dossier must be certified by the outsourcing ordering party (signature and seal), where label is pasted on an A4 size paper, it shall be stamped on its label.

1.3. Drug registration dossier must be written in Vietnamese. Names of components of the drug in the dossier must be the original name or common name in general use domestically and internationally. For herbal medicine, it must be written name of drug together with the scientific name in Latin.

1.4. Drug labels, drug use instruction: strictly comply with current regulations on labeling instructions and trademark of the drug. On the outer package label and instruction sheet must include the words: "Made in: (name the outsourcing taking party) under contract with: (name the outsourcing ordering party)" with equal font size. Labels printed on the bottle (tube) of injections, vials (tube) of oral solution with an area of the too small label, then allow only printing in name of the outsourcing taking party.

1.5. Drug registration dossier submitted to the Vietnam Drug Administration for assessment and grant of registration numbers. Vietnam Drug Administration shall send written notification of results no later than 30 days from the date of receipt of valid dossiers.

1.6. Drug registration facilities must pay registration fee in accordance with current provisions.

1.7. During the valid term of registration number, if both parties terminate the contract, outsourcing ordering party must report to the Vietnam Drug Administration to withdraw the registration number issued to drug produced by outsourcing.

2. Registration dossier of drug produced by outsourcing

2.1. Drug registration dossiers of domestic production facilities, institutes, and research centers ordering for outsourcing drug production having registration numbers for circulation in Vietnam:

- Cover page (Form No.1-DKT-SXGC).

- Contents of documents (Form No.2-DKT-SXGC)

- Application form (Form No.3A-DKT-SXGC) (In the application for registration, it must state clearly the production stage of outsourcing).

- Drug labels attached to Form No.4-DKT-SXGC (labels, instruction must be included full names of manufacturers involved in the stages of the production process).

- Drug testing slip produced at the outsourcing taking party.

- Sample of drug: 01 sample for one packing standard registered for circulation.

- Contract manufacturing, outsourcing of drugs meeting the content as prescribed in this Circular.

2.2. Drug registration dossier of the foreign manufacturer outsourced the production of drugs with registration number for circulation in Vietnam:

- Cover page (Form No.1-DKT-SXGC).

- Contents of documents (Form No.2-DKT-SXGC)

- Application form (Form No.3B-DKT-SXGC) (In the application for registration, it must state clearly the production stage of outsourcing).

- Drug labels attached to Form No.4-DKT-SXGC (labels, instruction must be included full names of manufacturers involved in the stages of the production process).

- Drug testing slip produced at the outsourcing taking party.

- Sample of drug: 01 sample for one packing standard registered for circulation.

- GMP certificate, permit for sale of drugs (FSC) or replaced two above licenses by a  valid certificate of pharmaceutical products (CPP) of the products registered for outsourcing production granted by the competent agency (For foreign drug).

- Contract of outsourcing production of drugs to meet the contents as prescribed in this Circular.

2.3. Registration dossier of drug without registration number in Vietnam of the domestic production facility ordering outsourcing for export, foreign manufacturer ordering and receiving the entire processed products:

- Cover page (Form No.1-DKT-SXGC).

- Contents of documents (Form No.2-DKT-SXGC).

- Application form (Form No.3A-DKT-SXGC or Form No.3B-DKT-SXGC) (In the application for registration, it must state clearly the production stage of outsourcing).

- Drug labels attached to Form No.4-DKT-SXGC (labels, instruction must be included full names of manufacturers involved in the stages of the production process).

- GMP certificate, permit for sale of drugs (FSC) or replaced two above licenses by a  valid certificate of pharmaceutical products (CPP) of the products registered for outsourcing production granted by the competent agency (For foreign drug).

- Technical standards and methods of drug testing provided by the outsourcing ordering party.

- The process of drug production provided by the outsourcing ordering party.

- Drug testing slip produced at the outsourcing taking party.

- Sample of drug: 01 sample for one packing standard registered for circulation.

- Contract of outsourcing production of drugs to meet the contents as prescribed in this Circular.

- A written commitment of drugs produced under the outsourcing contract not sold in Vietnam.

VI. EXAMINATION, INSPECTION, AND HANDLING OF VIOLATIONS

1. Examination – Inspection

1.1. Drug Administration of Vietnam shall preside over and coordinate with the Health Ministry Inspectorate, the departments of function to examine, inspect the implementation of this Circular for the units manufacturing, trading pharmaceutical products in the whole country.

1.2. Health Departments of provinces, cities directly under the Central Government are responsible for examining and inspecting the implementation of this Circular for the units manufacturing, trading pharmaceutical products within their respective local management.

2. Handling of violations

Organizations and individuals violating the provisions of this Circular, the current regulations concerning the production and circulation of drugs and other concerned provisions of law, depending on the seriousness of the violation will be handled according to law provisions.

VII. IMPLEMENTATION PROVISIONS

1. This Circular takes effect 15 days after its publication on the Official Gazette. The previous regulations contrary to this Circular are hereby annulled.

2. Drug Administration of Vietnam, the units under the Ministry of Health, Departments of Health in provinces and cities directly under the Central Government, the Vietnam Pharmaceutical Corporation, the pharmaceutical business enterprises, foreign companies with operating license in pharmacy are responsible for implementation of this Circular.

3. In the implementation process if any issues arise, the units report to the Health Ministry (Vietnam Drug Administration) for proper consideration and settlement./.