Enterprises importing and exporting medicines in Vietnam must meet the following conditions

Enterprises importing and exporting medicines in Vietnam must meet the following conditions (Internet image)

Article 3 of Circular 47/2010/TT-BYT stipulates that enterprises importing and exporting medicines in Vietnam must meet the following conditions:

- For traders who are enterprises of Vietnam:

= Enterprises having certificates of eligibility for medicine trading and medicine warehouses obtaining standard "Good Storage Practice" (GSP) are imported directly and received entrusting to import finished medicines and raw materials for making medicines, vaccines and medical biological products, medicines from medicinal material, traditional medicines, radioactive medicines are exempted from declaration licensing in accordance with the business scope stated in the certificate of eligibility for medicine trading and GSP certificate;

= Enterprises trading medical equipment and enterprises having certificates of eligibility for medicine trading are imported directly and received entrusting to import medical biological products for In Vitro diagnosis;

= Enterprises having certificates of eligibility for medicine trading and certificate obtaining standards "Good Manufacturing Practice" (GMP) are imported raw materials for medicine manufacture of such enterprises and sold to other medicine production enterprise;

= Production enterprises having certificates of eligibility for medicine trading from medicinal materials are imported to serve the needs of enterprises’ manufacturing and sold to other medicine production establishments, the traditional examination and treatment establishments;

= Enterprises having certificates of eligibility for medicine trading and valid permits to carry out radiation work granted by the competent authority are imported directly radioactive medicines not exempted from the declaration, grant.

- For traders who are enterprises with direct foreign-owned capital in Vietnam having certificates of eligibility for medicine trading (the scope of medicine production) are imported raw materials for medicine production of such enterprises. The export and import of medicines not serving for medicine production of such enterprises will be guided by the Ministry of Health in other documents.

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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