Circular 06/2003/tt-Byt: Guidelines For The Management And Use Of Vaccines, Medical Products Not Yet Registered Number In Circulation Are Of Aid In Case Of Emergency Or Imported Into Vietnam To Use

Original Language Title: Thông tư 06/2003/TT-BYT: Hướng dẫn việc quản lý và sử dụng vắc xin, sinh phẩm y tế chưa có số đăng ký lưu hành được viện trợ trong trường hợp khẩn cấp hoặc nhập khẩu vào Việt Nam để sử d

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Circulars on the management and use of vaccines, medical products not yet registered number in circulation are of aid in case of emergency or imported into Vietnam for use in special cases in order to strengthen the management and use of vaccines, medical products not yet registered number in circulation are of aid in case of emergency or imported into Vietnam for use in special cases, the Health Ministry guidelines on the management and use of the following: i. for vaccines, medical PRODUCTS NOT YET HAVING the REGISTRATION NUMBER to BE of AID in CASE of EMERGENCY 1. Organizations, foreign individuals in emergency aid for Vietnam the vaccines, medical products not yet registered number in circulation, are sent to the National Center for medical products the following: 1.1. A certificate of the competent authority country allows circulation or export vaccines, medical products.

1.2. The vote tested quality standard vaccines, biological health of national auditing agency country or other competent authority for shipments (certified copies of the import company).

2. Upon receipt of the documentation as defined in point 1 above, the national accreditation centre of medical products made of cold chain test, conducted sampling and conducting reviews of vaccines, medical products according to requirements: a) safety testing in the laboratory with the conclusion of prescribed standards.

b) safety tests on people in the field with the conclusion of standard according to regulation.

Particularly for vaccines, medical products not yet having the registration number issued by the international organization has frequently collaborated with Vietnam in the medical field such as WHO, UNICEF, ... aid in emergency cases for Vietnam, as the specific case, the national accreditation centre of medical products made of cold chain check , conducting sampling and testing of safety in the laboratory.

After considering the above mentioned documents and the auditing results, quality tests according to the regulations of national inspection center, biological medicine, suggested having the Department of health (Health Service) allows the unit to receive aid put to use vaccines, biological medical aid.

II. for a BRIEF medical PRODUCTS, PLEASE ENTER the PASSWORD to the PHILIPPINES DOES NOT YET HAVE the REGISTRATION NUMBER to USE in the SPECIAL CASE Of medical products, vaccines are only used in special cases serve the prevention of disease and for a particular audience group : foreigners living and working in Vietnam, the Vietnam travel, họe and work in the country has that disease. The vaccine, medical products on only used in medical institutions are allowed to vaccinate patients.

To import the vaccines, medical products on the import company, must submit to the Ministry of health (Health Service) the following documents: 1. The demands on the number, types of health products, vaccines and vaccination of subjects vaccinated establishments.

2. A pledge of base on vaccination production, preservation, vaccination, medical products for your purposes, the right audience, stand and be responsible for vaccination, health products (form attached).

3. A distribution company's commitments regarding quality assurance of vaccines, medical products provided to Vietnam (form attached).

4. A company's commitment to import on the import of preservation, transportation of vaccines, medical products meet the requirements of quality (form attached).

The basis of vaccination, the distribution company, the company imported must be responsible before the law about the vaccine's quality standards, medical products units to use, distribute and import.

III. ENFORCEMENT Of TERMS 1. The Minister of Health Affairs for the Director of the preventive medicine is responsible for considering and allows import of some vaccines, biological medical aid in case of emergencies and for use in special cases according to the current rules.

2. national accreditation centre of medical products is responsible for: a) receiving the records related to vaccines, biological medical aid and conducted inspection, testing in the laboratory and on field under current rules.

b) after auditing results, and test national test center, biological medicine, reports the results to the Ministry of health (Health Service).

3. the Director of the Central Institute of hygiene and epidemiology and the Chairman of the expanded immunization program is fully responsible for the use of vaccines was allowed to circulate in the program and periodic reporting, the use of vaccines: side effects, complications due to the use of vaccines and other extraordinary cases during use.

4-the heads of the units receiving aid is responsible for the preservation, distribution, used to ensure the quality of products to consumers, not sold.

This circular effect after 15 days from the date The report: In the process if there are difficulties and obstacles, which must be promptly reported to the Ministry of health (Health Service) to study the resolution.

The SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness...................., on ... ... ... ... ... ... in 200.

A COMMITMENT to fulfill the conditions for use of the vaccine, medical products dear: Service of preventive medicine-Ministry of health


Business.................................................................................................................................................................................................................. Address: phone: Fax: Please suggest the Health Ministry considered for import of products not yet available in the registry: vaccine Name, order number, amount, dosage, packing unit number please enter the name of the production unit (name the country) the name of the distribution unit (name the country) the purpose of use 1. Accompanied by provision of....................

2. preservation and vaccination unit: 3. The enclosed profile: after the registration regulation research vaccines, biological region room attached to decision 2010/BYT-QĐ dated 28/10/1996 of the Minister of health, circular No. 09/2001/TT-BYT on 21/5/2001 directions perform the export , imported vaccines, born immune products for the period 2001-2005, we committed to implement the preservation conditions, use of the vaccine, medical products on in this circular, regulation and other prevailing regulations related to this field, subject to inspection, inspection of the competent bodies. Medical products, vaccines are only used in the body, and vaccination units mentioned above. If violated, we would completely responsible before the law on standards of quality and intended use, as well as all matters relating to the use of vaccines.


 



BUSINESS DIRECTOR (signature, stamp) of the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness...................., on ... ... ... ... ... ... in 200.

A COMMITMENT to fulfill the conditions of use of vaccines and vaccination, medical products dear: Service of preventive medicine-Ministry of health vaccination basis:.................................................................................................................................................................................................................. Address: phone: Fax: Please suggest the Health Ministry considered to enter the product does not yet have the following registry order number: Name of vaccine, dosage, content, packing unit number please enter the name of the production unit (name the country) object using 1 2 3 after registration regulation research vaccines, biological region room attached to decision 2010/BYT-QĐ dated 28/10/1996 of the Minister of health We are committed to use the vaccine, medical products on the right purpose, the right audience, the right specified in this regulation and the rules related to this field. Subject to inspection, inspection of the competent bodies. Only use, vaccination in our bodies. In the event of a disaster or other violations occurred, we would absolutely be responsible before the law on purpose, object, specify the vaccination, as well as all matters relating to the use of vaccines.


 



DIRECTOR of the BASIS of VACCINATION (signature, stamp) COMMITMENT A commitment To ensure the quality of vaccines and medical biological products to ensure the quality of vaccines, medical products To: Department of preventive medicine Ministry of Health, s. r. Vietnam 138A Giang Vo Street, Hanoi, Vietnam Dear Healthcare đự Vietnam Socialist Republic Ministry of health room 138A Vo, Hanoi, Company'name Vietnam: SOCIALIST distribution company Name: Address: address: Telephone number: Fax: Telex: phone: fax: Telex: We ensure that the following vaccines and medical biological products distributed by our company: we are pleased to ensure the vaccines, medical products supplied by us then: No Name of vaccine , biologicals, Packaging form.

(Name of vaccines, biological and packing)



Was produced by (produced by) Produced according to GMP criteria and met with all requirements setting for the quallty of vaccines and biological products of local authorities. These products were also sold freely in: produced according to GMP standards, and requirements for the quality of vaccines, the medical products Agency's jurisdiction. The above products are allowed to circulate in: We commit ourself to comform to the law and regulation in the field of vaccines and biological products and accept the inspection and examination of Vietnam authorities.

We will bear a responsibilities for the quality of the above vaccines and biological products.

We would like to obey the laws and regulations in the field of vaccines, medical products of the Socialist Republic of Vietnam and subject to inspection by the competent authorities of Vietnam.

We're totally responsible to the law about the vaccine's quality standards, medical products on.


 



Director (Director) (Sign) (signed)