What is the expiry date of imported medicines under the law in Vietnam?

What is the expiry date of imported medicines under the law in Vietnam? (Internet image)

Clause 2, Article 4 of Circular 47/2010/TT-BYT stipulates the expiry date of imported medicines in Vietnam as follows:

- Finished medicines imported into Vietnam with expiry date of more than 24 months, the remaining expiry date must be at least 18 months from the date of arrival in Vietnam. For medicine with expiry date of equal to or less than 24 months the remaining expiry date must be at least 12 months from the date of arrival in Vietnam;

- Vaccines, medical biological products without registration numbers, when imported into Vietnam they must have a remaining expiry date of at least by 2/3 of expiry date from the date of arrival in Vietnam;

- Vaccines, medical biological products with valid circulation registration numbers in Vietnam, when imported into Vietnam, they must have a remaining expiry date of at least by 1/2 of expiry date from the date of arrival in Vietnam;

- Biological products used in In Vitro diagnosis with expiry date of equal to or less than 12 months when imported into Vietnam, they must have a remaining expiry date of at least by 03 months from the date of arrival in Vietnam;

- Raw materials for making medicines imported into Vietnam, except for pharmaceutical materials, must have remaining expiry date of more than 36 months from the date of arrival in Vietnam, for raw materials with expiry date of equal to or less than 36 months, the arrival date of the Vietnam's ports is not exceeded 06 months from date of manufacture;

- Medicine of aid, humanitarian aid with expiry date of more than or equal to 24 months, the remaining expiry date of medicine must have a minimum period of 12 months from the date of arrival in Vietnam. Where medicine with expiry date of less than 24 months, the remaining expiry date from the date of arrival in Vietnam is at least equal to 1/3 of medicine’ expiry date;

- The medicines and medicine-making materials not meeting the regulations on expiry date of medicines specified above but ensuring the quality and need to be imported to serve the needs of treatment, demand in the domestic production of medicines, Drugs Administration Department - Ministry of Health shall consider and decide and be responsible for grant of import permits.

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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