Imported vaccines subject to testing, clinical trial in Vietnam

Imported vaccines subject to testing, clinical trial in Vietnam (Internet image)

Clause 5, Article 4 of Circular 47/2010/TT-BYT stipulates the following:

 For vaccines and medical biological products as serum containing antibodies used to disease prevention and treatment with or without circulation registration numbers in Vietnam imported, after the customs clearance, they are taken to the warehouse of enterprise for storage as prescribed and only allowed to put into use when having written certification of the National Institute for Expertise of Vaccines and Medical Biological Products that lots of vaccines, serum containing antibodies used to prevent and treat disease imported obtain standards of quality and safety on experimented animals.

- For vaccines and medical biological products as serum containing antibodies for disease prevention and treatment without the import registration number used for the programs and national projects, they are required to implement clinical trial of medicines prepared as prescribed in Decision No.01/2007/QD-BYT on 11/01/2007 of the Minister of Health stipulating on clinical trial of medicines.

- Particularly for vaccines and medical biological products as serum containing antibodies for disease prevention and treatment without circulation registration numbers but they are pre-tested by the World Health Organization (WHO) and circulated worldwidely by the international organizations which regularly cooperate with Vietnam in the medical field such as WHO, UNICEF ... aid to Vietnam, as the case by case basis, the Drugs Administration Department - Ministry of Health requires proof of cold chain implementation and results of safety testing satisfactory on human in the field, then they are allowed put to use.

- With respect to vaccines and medical biological products as serum containing antibodies for disease prevention and treatment imported under the provisions of Article 13, 14, 15 and 16 of this Circular, if necessary, the Drugs Administration Department - Ministry of Health will require safety testing on humans in the field and after obtaining satisfactory results on safety testing on humans in the field, they are allowed to put into use.

More details can be found in Circular 47/2010/TT-BYT, which comes into force from February 12, 2011.

Nguyen Phu

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