Circular No. 06/2004/TT-BYT guiding the production and processing of medicines

CIRCULAR

Issued by the Ministry of Health Decision No. 06/2004/TT-BYT dated May 28, 2004 on guiding the production and processing of medicines

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Pursuant to the Law on People's Health Protection dated July 11, 1989 and the Drug Regulation for Disease Prevention and Treatment issued together with Government Decree No. 23/HĐBT dated January 24, 1991 (now the Government);

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

Pursuant to the Commercial Law;

Pursuant to Government Decree No. 57/1998/NĐ-CP dated July 31, 1998 detailing the implementation of the Commercial Law regarding export, import, processing, and agency sales of goods with foreign countries; Pursuant to Government Decree No. 44/2001/NĐ-CP dated August 2, 2001 amending and supplementing certain articles of Government Decree No. 57/1998/NĐ-CP dated July 31, 1998 detailing the implementation of the Commercial Law regarding export, import, processing, and agency sales of goods with foreign countries;

To fully utilize the pharmaceutical production capacity of domestic enterprises, enhance production cooperation, improve the quality of medicines circulating in Vietnam, and better meet the people's demand for medical drugs, the Ministry of Health guides the production and processing of medicines as follows:

I. GENERAL PROVISIONS

1. Scope of Application and Regulatory Scope

1.1. Scope of application:

- Organizations, businesses, individuals engaged in pharmaceutical production, and legitimate Research Institutes/Centers according to Vietnamese laws.

- Foreign manufacturers having permits to operate in the pharmaceutical sector in Vietnam.

1.2. Scope of regulation:

- Processing activities of medicines already registered for circulation in Vietnam (excluding medicines containing active ingredients or formulations listed in the directory of new registration applications and re-registration applications for foreign medicines issued by the Ministry of Health).

- Processing activities of medicines not yet registered for circulation in Vietnam: For foreign medicines, the party placing the order must take back the entire processed product; For domestic medicines, the processing party must export the entire processed product.

2. Explanation of terms

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

2.1. Processing of medicines refers to a manufacturer (the party placing the order) owning a medicine (with or without a registration number in Vietnam) entrusting another manufacturer in Vietnam (the processing party) to produce that medicine. The processing party returns the finished product to the party placing the order in exchange for a manufacturing fee agreed upon in the contract.

2.2. The party placing the order is a manufacturer owning the medicine to be processed.

2.3. The processing party is the entity undertaking the production and receiving the manufacturing fee from the party placing the order.

2.4. Production under this Circular means:

* For foreign medicines:

- Processing all stages of the production process and can only be entrusted to one processing party.

- Processing one stage of the production process and can only be entrusted to one processing party, applicable to special formulations that Vietnam has not yet produced: Freeze-dried powder for injection, sustained-release tablets, controlled-release tablets, suppositories, special formulations for children.

* For domestically produced medicines, processing one or all stages of the production process and can only be entrusted to one processing party.

3. Registration Number for Circulation of Processed Medicines

3.1. Medicines processed through all stages of the production process will be granted a processing registration number and allowed to circulate in Vietnam. The validity period of the registration number for processed medicines is a maximum of five years from the date of issuance. The validity of the old registration number will terminate immediately upon the issuance of the processing registration number.

3.2. Medicines processed through one stage of the production process continue to be produced under the existing registration number and must submit an application for registration in accordance with this Circular.

3.3. Import and export of processed medicines shall be carried out in accordance with regulations stipulated in legal documents guiding the implementation of the Commercial Law concerning export, import, processing, and agency sales of goods with foreign countries; Current regulations of the Ministry of Health on drug import and export management at different periods, and other relevant legal documents.

II. REGULATIONS FOR THE PARTY PLACING THE ORDER TO PRODUCE MEDICINES

1. Conditions for being named as the Party Placing the Order:

The following entities may be named as the Party Placing the Order:

1.1. Legitimate Vietnamese pharmaceutical production facilities with medicines holding valid registration numbers or medicines without registration numbers in Vietnam for export processing.

1.2. Foreign pharmaceutical manufacturers possessing a "Permit for Foreign Enterprises Operating in the Pharmaceutical Sector in Vietnam" for processing medicines already registered for circulation in Vietnam by the Vietnamese Ministry of Health, or medicines without registration numbers in Vietnam which the party placing the order will take back the entire product.

1.3. Institutes and Centers with medicines holding valid research registration numbers issued by the Vietnamese Ministry of Health.

2. Responsibilities of the Party Placing the Order

2.1. Responsible for registering the medicine with the Vietnam Drug Administration.

2.2. Supply raw materials and auxiliary materials in accordance with quantity, quality, time frame, and location to the processing party, or provide standards for raw materials and auxiliary materials so that the processing party can supply them during the production process.

2.3. Provide production procedures, technical standards, and testing methods for initial raw materials, semi-finished products, and finished products, as well as other related documents for the processing of medicines.

2.4. Retain all relevant files and documents related to the distribution process and quality assurance of medicines circulating in the market.

2.5. Be responsible for the quality, safety, and efficacy of medicines for consumers during their circulation in the market.

2.6. Be responsible for intellectual property rights for medicines placed for processing.

3. Rights of the Party Placing the Order

3.1. Own the registration number and the product.

3.2. Receive the processed product according to the agreed method, timeframe, and conditions.

3.3. Have the right to refuse to accept processed products that do not meet the agreed quality standards as stipulated in the contract.

III. REGULATIONS FOR THE PARTY RECEIVING THE ORDER TO PROCESS MEDICINES

1. Conditions for being named as the Party Receiving the Order.

Is a production facility that has been issued a Good Manufacturing Practice (GMP) certificate for pharmaceutical manufacturing by the Vietnam Drug Administration, suitable for the drugs intended to be manufactured under contract.

2. Responsibilities of the Contract Manufacturer

2.1. Carry out drug production according to the specified procedures and techniques and ensure the quality of the drugs in accordance with the registered drug dossier and the requirements stipulated in the signed contract.

2.2. If the Contract Manufacturer supplies the initial raw materials itself, it must ensure their quality in compliance with the standards set by the Contracting Party.

2.3. Request the Contracting Party to provide the production process, technical standards, and testing methods for initial raw materials, semi-finished products, and finished products, as well as other relevant documents related to the contract manufacturing of drugs.

2.4. Retain all relevant files, documents, and samples related to the drug manufacturing process.

2.5. Be responsible for product quality control throughout the production process and ensure the quality of the product until its delivery back to the Contracting Party.

2.6. Return the processed products, surplus raw materials, waste, and by-products to the Contracting Party upon completion of the contract manufacturing agreement as prescribed.

3. Rights of the Contract Manufacturer

3.1. Receive payment for work performed in accordance with the agreed terms.

3.2. Have the right to request the Contracting Party to supply raw materials in the correct quantity, quality, time frame, and location as stipulated in the contract.

3.3. Have the right to refuse to accept contract manufacturing if the Contracting Party provides raw materials that do not meet the quality standards agreed upon in the contract.

IV. CONTRACT MANUFACTURING OF DRUGS AGREEMENT

The contract manufacturing of drugs agreement must be documented in writing and must comply with current Vietnamese laws governing contracts, in addition to including the following contents:

1. Agreement on the supply of raw materials, provision of production processes, technical standards, and testing methods for initial raw materials, semi-finished products, finished products, and other relevant documents related to the contract manufacturing of drugs.

2. Rights and responsibilities of each party regarding the quality control of raw materials, semi-finished products, finished products, packaging procedures, and labeling, including clear provisions on signing batch test certificates and dispatch certificates for finished products.

3. Rights and responsibilities of each party concerning the retention of production records, quality control, distribution, circulation of drugs, sample retention, resolution of quality-related issues, complaints, and market recalls.

4. Procedures and formalities for inspecting the Contract Manufacturer's production facilities.

5. Circumstances for terminating the contract.

V. REGISTRATION OF CONTRACT MANUFACTURED DRUGS

1. General Guidelines

1.1. The drug registration dossier for contract-manufactured drugs must be prepared in three sets, one of which must be the original. If there is no original, certified copies must be provided for the following documents:

- Drug Circulation Permit (FSC)

- Good Manufacturing Practice (GMP) Certificate or substitute these two permits with a Product Certification (CPP)

Additionally, two complete sets of drug labels must accompany the registration dossier. The dossier must be clearly printed on A4 paper, arranged in the prescribed sequence, with clear divisions between sections.

1.2. All documents in the dossier must be confirmed by the Contracting Party (signed and stamped). In cases where drug labels are affixed to A4 paper, they must be stamped across the label.

1.3. The drug registration dossier must be written in Vietnamese. The names of drug components in the dossier must be either the generic name or the commonly used name both domestically and internationally. For herbal medicines, the scientific name in Latin must also be included.

1.4. Drug labels and instructions for use: Must comply with current regulations on labeling and trademarking of drugs. On the outer packaging label and instruction leaflet, the phrase "Manufactured by: (Name of the Contract Manufacturer) pursuant to a contract with: (Name of the Contracting Party)" must be printed in equal font size. For small labels on vials or bottles of injectable or oral solutions, only the name of the Contract Manufacturer may be printed.

1.5. The drug registration dossier must be submitted to the Vietnam Drug Administration for review and issuance of a registration number. The Administration will respond within no more than thirty days from the date of receipt of a complete and valid dossier.

1.6. The entity registering the drug must pay the registration fee as prescribed.

1.7. During the validity period of the registration number, if both parties terminate the contract, the Contracting Party must report to the Vietnam Drug Administration to withdraw the registration number granted for the contract-manufactured drug.

2. Registration Dossier for Contract Manufactured Drugs

2.1. Registration dossier for domestic production facilities, Institutes, Research Centers contracting to manufacture drugs already registered for circulation in Vietnam:

- Cover page (Form No. 1-ĐKT-SXGC).

- Table of contents (Form No. 2-ĐKT-SXGC)

- Application form (Form No. 3A-ĐKT-SXGC) (The application form must specify the contract manufacturing stages).

- Drug label attached to Form No. 4-ĐKT-SXGC (On the label and instruction leaflet, the names of all manufacturers involved in the production stages must be fully stated).

- Test report of the drug produced at the Contract Manufacturer.

- Sample drug: One sample for each packaging specification registered for circulation.

- Contract manufacturing agreement meeting the requirements stipulated in this Circular.

2.2. Registration dossier for foreign manufacturers contracting to manufacture drugs already registered for circulation in Vietnam:

- Cover page (Form No. 1-ĐKT-SXGC).

- Table of contents (Form No. 2-ĐKT-SXGC)

- Application form (Form No. 3B-ĐKT-SXGC) (The application form must specify the contract manufacturing stages).

- Drug label attached to Form No. 4-ĐKT-SXGC (On the label and instruction leaflet, the names of all manufacturers involved in the production stages must be fully stated).

- Test report of the drug produced at the Contract Manufacturer.

- Sample drug: One sample for each packaging specification registered for circulation.

- Good Manufacturing Practice (GMP) Certificate, Drug Circulation Permit (FSC) or substitute these two permits with a Product Certification (CPP) for the product being registered for contract manufacturing, issued by the competent authority and still valid (For foreign drugs).

- Contract manufacturing agreement meeting the requirements stipulated in this Circular.

2.3. Documents for registering drugs without a circulation registration number in Vietnam produced by domestic manufacturing entities for processing to export, and foreign manufacturers placing orders for processing and reclaiming the entire processed product:

- Cover page (Form No. 1-ĐKT-SXGC).

- Table of contents of the dossier (Form No. 2-REG-MFG).

- Application for registration (Form No. 3A-REG-MFG or Form No. 3B-REG-MFG). (The application for registration must clearly state the production stages of the processing).

- Drug label attached to Form No. 4-ĐKT-SXGC (On the label and instruction leaflet, the names of all manufacturers involved in the production stages must be fully stated).

- Good Manufacturing Practice (GMP) Certificate, Drug Circulation Permit (FSC) or substitute these two permits with a Product Certification (CPP) for the product being registered for contract manufacturing, issued by the competent authority and still valid (For foreign drugs).

- Technical standards and testing methods for the drug provided by the party placing the order for processing.

- Drug production process provided by the party placing the order for processing.

- Test report of the drug produced at the Contract Manufacturer.

- Sample drug: One sample for each packaging specification registered for circulation.

- Contract manufacturing agreement meeting the requirements stipulated in this Circular.

- Declaration that the drugs produced under the processing contract will not be consumed in Vietnam.

VI. INSPECTION, AUDIT AND SANCTIONS FOR VIOLATIONS

1. Inspection - Audit

1.1. The Vietnam National Medicines Administration shall take the lead and coordinate with the Ministry of Health Inspectorate, relevant Departments and Bureaus to organize inspections and audits on the implementation of this Circular for pharmaceutical production and trading units nationwide.

1.2. Provincial Health Services under centrally governed cities shall be responsible for inspecting and auditing the implementation of this Circular for pharmaceutical production and trading units within their jurisdiction.

2. Disciplinary Actions

Organizations and individuals violating the provisions of this Circular, current regulations related to drug production and circulation, and other relevant laws shall be subject to sanctions according to the severity of the violation as stipulated by law.

VII. IMPLEMENTATION PROVISIONS

1. This Circular shall take effect fifteen days from the date of publication in the Official Gazette. Previous provisions contrary to the content of this Circular shall be abolished.

2. The Vietnam National Medicines Administration, subordinate units of the Ministry of Health, Provincial Health Services under centrally governed cities, the Vietnam Pharmaceutical Corporation, pharmaceutical trading enterprises, and foreign companies operating in the pharmaceutical sector with valid permits shall be responsible for implementing this Circular.

3. In case of any difficulties during implementation, units shall report to the Ministry of Health (Vietnam National Medicines Administration) for consideration and appropriate resolution.