Title: Circular 23/2013/TT-BYT provides for drug processing, dossier to register drug processing, order and procedures for registration, suspension and withdrawal of registration number of drug process.

Type: Circular

Issuing Agency: Ministry of Health

Responsible Agency: Ministry of Health

Issuing Date: 13-08-2013

GENERAL PROVISIONS

Article 1. Scope of regulation and subject of application

1. This Circular provides for drug processing, dossier to register drug processing, order and procedures for registration, suspension and withdrawal of registration number of drug process.

2. This Circular applies to domestic and foreign organizations and individuals having activities related to the drug processing and registration for circulation of processed drug in Vietnam.

Article 2. Explanation of term

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

1. Drug processing is that the processing Party performs work to make products as required by the Ordering Party and the Ordering Party receives products and makes payment of remuneration under the agreement in accordance with the regulations of law.

The processing Party's job is to implement the processing of one, a number or all stages of the drug manufacturing process (receipt of raw materials, processing and packaging including packaging in the final packing and labeling).

2. Drug ordered for processing is the drug issued with Permit for circulation or product export by the pharmaceutical management agency; issued with patent or researched by very ordering Party for drugs without circulation registration number in Vietnam.

3. Ordering Party is the Party submitting application for issuance of Permit for circulation of drug processing.

4. Processing Party is the Party manufacturing and receiving remuneration of manufacturing from the ordering Party. The processing Party may consist of a lot of manufacturers and each manufacturer is involved in one or a lot of stages of manufacturing.

5. Processing contract is the agreement between the Parties, accordingly, the processing Parties perform work to make products as required by the ordering Party which shall receive and make payment of processing remuneration.

6. Transitional processing is the drug processing in which there are a lot of processing parties, thus:

- The processed products of this processing contract shall be used as processing materials for other processing contracts in Vietnam;

- The processed products of processing contract of previous stages shall be delivered to other manufacturers designated by the ordering Party for the processing contract of the following stages.

Chapter II

REGULATIONS ON DRUG PROCESSING

Article 3. Conditions for drug processing

1. Conditions to be the name of the ordering Party

The Vietnamese legal drug business establishments, foreign drug business and manufacturing establishments that have “Operation Permit of foreign enterprises on drugs and drug materials in Vietnam” and drugs whose registration number has been issued by the Vietnam Ministry of Health and is still valid or that are the patent owners or research subjects accepted as prescribed by Vietnam law or product research materials at the processing establishment for drugs without circulation registration number in Vietnam ordered for manufacturing and processing.

2. Conditions to be the name of the processing Party

a) For pharmaceutical chemical drugs, herbal drugs (except for oriental drug), vaccines, sera containing antibodies, biomedical products: manufacturing establishment in Vietnam with certificates of eligibility for drug business and certificate of standard satisfaction of "Good manufacturing practice" (GMP) with the dosage form of suitable for drugs intended for processing.

b) For in vitro diagnostic biological products: manufacturing establishment in Vietnam with certificate of eligibility for drug business and certificate of standard satisfaction of "Good manufacturing practice" (GMP) or TCVN ISO 13485 or other equivalent standards with the dosage form of suitable for drugs intended for processing.

Article 4. Rights and obligations of the ordering Party and the processing Party

1. For ordering Party:

a) Owning registration number and processed products;

b) Ordering the processing of one or a number of manufacturing stage from the processing Party;

c) Receiving the processed products in accordance with the method, time limit and terms agreed in the contract;

d) Taking responsibility for registration of processed drug in accordance with the order and registration procedures prescribed in Circular No. 22/2009/TT-BYT dated November 24, 2009 by the Minister of Health stipulating drug registration (hereafter referred to as Circular No. 22/2009/TT-BYT);

đ) Performing the rights and obligations of drug registration establishment in accordance with Circular No. 22/2009/TT-BYT, the right to import and export as prescribed by law on import and export of drug;

e) Providing manufacturing processes, technical standards and testing methods of original materials, semi-finished and finished products, and other papers relating to the drug processing;

g) Making payment of processing remuneration as agreed in the contract;

h) Taking responsibility for the quality, safety and efficiency of processed and manufactured drugs during the course of drug circulation;

i) Taking responsibility for issues relating to intellectual property of drug registered for circulation and the other rights and obligations under the provisions of law on commercial processing.

2. For processing Party:

a) Receiving remuneration as agreed in the contract;

b) Having the right to require the ordering Party to deliver materials with proper amount, quality, time limit and location as agreed in the contract. If the processing Party itself may provide original materials, it must ensure the quality of materials in accordance with the ordering Party’s standards.

c) Having the right to refuse to receive the processing if the ordering Party provide materials which do not meet quality standard as stated in the signed contract;

d) Requiring the ordering Party to provide manufacturing processes, technical standards and testing methods of original materials, semi-finished and finished products, and other papers relating to the drug processing.

đ) Manufacturing drugs in accordance with the process, techniques and drug quality assurance in line with drug registration dossier and ordering Party’s requirements specified in the signed contract;

e) Keeping dossiers, materials and drug samples related to drug manufacturing process and providing those dossiers to the competent state agencies as required;

g) Taking responsibility for product quality testing throughout the manufacturing process and product quality assurance until delivering the processed products to the ordering Party;

h) Processed products, surplus materials, scrap, waste products after completion of the processing contract as agreed by both Parties in accordance with regulations of law;

i) Other rights and obligations as prescribed by law on commercial processing.

 

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