Circular No. 06/2003/TT-BYT guides the management and use of vaccines and medical products without registration numbers that are donated in emergency situations or imported into Vietnam for special purposes.

CIRCULAR

DECREE NO. 06/2003/TT-BYT OF MAY 15, 2003 GUIDING THE MANAGEMENT AND USE OF MEDICAL BIOLOGICALS WITHOUT REGISTRATION NUMBERS PROVIDED AS AGRICULTURAL ASSISTANCE IN EMERGENCY SITUATIONS OR IMPORTED INTO VIETNAM FOR SPECIAL CASES
USE OF VACCINES AND MEDICAL PRODUCTS WITHOUT REGISTRATION NUMBER FOR DISTRIBUTION IN EMERGENCY SITUATIONS
OR IMPORTED INTO VIETNAM FOR USE IN SPECIAL CASES
REGISTRATION FOR ASSISTANCE IN EMERGENCY SITUATIONS IN VIETNAM WITHOUT REGISTRATION NUMBER FOR USE
IN SPECIAL CASES

To strengthen the management and use of medical biologicals without registration numbers provided as agricultural assistance in emergency situations or imported into Vietnam for special cases, the Ministry of Health guides the following management and use procedures:

I. REGARDING MEDICAL BIOLOGICALS WITHOUT REGISTRATION NUMBERS PROVIDED AS AGRICULTURAL ASSISTANCE IN EMERGENCY SITUATIONS
REGISTRATION FOR EMERGENCY ASSISTANCE

1. Foreign organizations and individuals providing emergency assistance to Vietnam with medical biologicals without registration numbers must submit the following documents to the National Institute of Hygiene and Epidemiology for Quality Control:

1.1. Certificate from the competent authority of the country of origin allowing circulation or export of the medical biologicals.

1.2. Test report confirming the quality standards of the medical biologicals issued by the national quality control agency of the country of origin or another authorized agency for the batch (with a certified true copy from the importing company).

2. Upon receipt of the documents as stipulated in point 1 above, the National Institute of Hygiene and Epidemiology will conduct cold chain checks, take samples, and evaluate the medical biologicals according to the requirements:

a) Laboratory safety testing with a conclusion meeting the prescribed standards.

b) Field safety testing on humans with a conclusion meeting the prescribed standards.

For medical biologicals without registration numbers provided as emergency assistance to Vietnam by international organizations that have regularly cooperated with Vietnam in the health sector such as WHO, UNICEF, etc., the National Institute of Hygiene and Epidemiology will conduct cold chain checks, take samples, and perform laboratory safety testing based on specific circumstances.

After reviewing the aforementioned documents and with the test results meeting the prescribed quality standards, the National Institute of Hygiene and Epidemiology will issue a letter recommending the Ministry of Health (Preventive Medicine Department) to allow the receiving unit to use the donated medical biologicals.

II. REGARDING IMPORTED MEDICAL BIOLOGICALS WITHOUT REGISTRATION NUMBERS FOR USE IN SPECIAL CASES
IN VIETNAM, THERE IS NO REGISTRATION NUMBER YET FOR USE
IN SPECIAL CASES

These medical biologicals are only used in special cases to serve disease prevention and control efforts and for a specific group: foreign nationals living and working in Vietnam, Vietnamese citizens traveling, studying, and working in countries where these diseases are circulating. The medical biologicals can only be used at vaccination centers permitted to administer them.

To import these medical biologicals, the importing company must submit the following documents to the Ministry of Health (Preventive Medicine Department):

1. Quantity and type of medical biologicals needed and the target population for vaccination from the vaccination center.

2. Commitment from the vaccination center regarding the proper use, storage, and administration of the medical biologicals to the correct target population and indications, and responsibility for administering the medical biologicals (according to the attached model).

3. Commitment from the distribution company regarding ensuring the quality of the medical biologicals supplied to Vietnam (according to the attached model).

4. Commitment from the importing company regarding proper storage and transportation of the medical biologicals to meet quality requirements (according to the attached model).

Vaccination centers, distribution companies, and importing companies are responsible under the law for the quality standards of the medical biologicals used, distributed, and imported by their units.

III. IMPLEMENTATION PROVISIONS

1. The Minister of Health assigns the Director of the Preventive Medicine Department to be responsible for examining and approving the importation of certain medical biologicals provided as emergency assistance and for use in special cases in accordance with current regulations.

2. The National Institute of Hygiene and Epidemiology is responsible for:

a) Receiving relevant files related to donated medical biologicals and conducting quality control and laboratory and field testing according to current regulations.

b) After obtaining the test results, the National Institute of Hygiene and Epidemiology reports the results to the Ministry of Health (Preventive Medicine Department).

3. The Director of the Central Institute of Hygiene and Epidemiology and the Head of the Expanded Immunization Program are fully responsible for the use of approved medical biologicals in the program and must periodically report on the use of vaccines: side effects, adverse events following immunization, and other unusual occurrences during use.

4. Heads of receiving units are responsible for storing, distributing, and using the products to ensure product quality reaches consumers and must not sell them.

This circular takes effect fifteen days after its publication in the Official Gazette:

During implementation, if there are difficulties or obstacles, units must promptly report to the Ministry of Health (Preventive Medicine Department) for research and resolution.

SOCIALIST REPUBLIC OF VIET NAM

Independence - Freedom - Happiness

..., day...month...year 200...

COMMITMENT FORM

Fulfill all conditions for the use of vaccines,
medical biologicals

Respectfully submitted to: Preventive Medicine Department - Ministry of Health

Enterprise...

....................................................................................................................

Fax:

Email/Website: 2. Intellectual Property Rights Owner:

Request the Ministry of Health to consider the importation of products without registration numbers as follows:

1. Attached budget estimate...

2. Storage and vaccination unit:

3. Attached file:

After studying the Regulation on Vaccine Registration, Medical Biological Products issued together with Decision No. 2010/BYT-QĐ dated October 28, 1996 of the Minister of Health, and Circular No. 09/2001/TT-BYT dated May 21, 2001 guiding the implementation of vaccine and medical biological product export and import for human use during the period of 2001-2005, we hereby commit to strictly comply with the storage conditions and usage stipulated in this Regulation, Circular, and other current regulations related to this field, and accept supervision and inspection by competent authorities. The vaccines and medical biological products mentioned herein shall only be used and administered in the aforementioned organizations and units responsible for storage and administration. In case of violation, we shall fully assume responsibility under the law regarding the quality standards and intended use of these vaccines, as well as any issues related to their use.

ENTERPRISE DIRECTOR

(Signature, stamp)

SOCIALIST REPUBLIC OF VIET NAM

Independence - Freedom - Happiness

..., day...month...year 200...

COMMITMENT FORM

Fulfill all conditions for the use of vaccines,
storage and administration of vaccines and medical biological products

Respectfully submitted to: Preventive Medicine Department - Ministry of Health

Vaccination facility:...

....................................................................................................................

Fax:

Email/Website: 2. Intellectual Property Rights Owner:

Request the Ministry of Health to consider the importation of products without registration numbers as follows:

After studying the Regulation on Vaccine Registration, Medical Biological Products issued together with Decision No. 2010/BYT-QĐ dated October 28, 1996 of the Minister of Health, we hereby commit to using the aforementioned vaccines and medical biological products strictly for their intended purpose, target population, and indications as stipulated in this Regulation and other current regulations related to this field. We accept supervision and inspection by competent authorities. These products shall only be used and administered within our organization. In the event of adverse reactions or other violations, we shall fully assume responsibility under the law regarding the intended use, target population, and indications for administration, as well as any issues related to the use of these vaccines.

DIRECTOR OF THE VACCINATION FACILITY

(Signature, stamp)

COMMITMENT

Commitment Letter

To ensure the quality of vaccines and medical biological products

Ensure the quality of vaccines and medical biological products

To: Department of Preventive Medicine

Ministry of Health, Socialist Republic of Vietnam

138A Giang Vo Street, Hanoi, Vietnam

Respectfully submitted to: Accounting Y preventive medicine

AND Y medical product country Socialist Republic of Vietnam abroad

138A Giang Vo, Hanoi, Socialist Republic of Vietnam abroad

Company's name:

Name of Distributing Company:

Address:

Fax:

Telephone number: 2. Intellectual Property Rights Owner: Telex:

Email/Website: Fax number: Telex:

We ensure that the following vaccines and medical biological products distributed by our company:

We hereby guarantee the following vaccines and medical biological products provided by our company:

Produced according to GMP criteria and met with all requirements set for the quality of vaccines and biological products of local authorities. These products were also allowed to circulate freely in:

Produced according to GMP standards and met all requirements set by local authorities for the quality of vaccines and medical biological products. These products were also permitted to circulate freely in:

We commit ourselves to conform to the laws and regulations in the field of vaccines and biological products and accept the inspection and examination by Vietnamese authorities.

We will bear full responsibility for the quality of the above vaccines and biological products.

We hereby comply with the laws and regulations in the field of vaccines and medical biological products of the Socialist Republic of Vietnam and accept supervision and inspection by Vietnamese competent authorities.

We hereby fully assume responsibility under the law regarding the quality standards of the above vaccines and medical biological products.

DIRECTOR

(Director)

(Signature)

(signature)