What conditions must drug manufacturing activities meet?

According to the provisions of Article 3 of Circular 23/2013/TT-BYT, when organizations or individuals, both domestic and foreign, engage in activities related to drug outsourcing and register for outsourced drug circulation in Vietnam, they must ensure the following conditions:

Illustrative image (source: internet)

First, the conditions to be named as the Outsourcing Assigner:

- A legal drug business establishment in Vietnam or a foreign drug manufacturing and business establishment with the "License for foreign enterprises to operate drugs and drug materials in Vietnam," has drugs registered with valid numbers issued by the Vietnam Ministry of Health, or is the owner of a patent or a research project that has been accepted according to the provisions of Vietnamese law or research documents of products at the same outsourcing assigner’s establishment for drugs that do not yet have a registration number for circulation in Vietnam.

Second, the conditions to be named as the Outsourcing Assignee:

- For chemical pharmaceuticals, herbal drugs (excluding traditional medicine), vaccines, serum containing antibodies, medical biological products: a manufacturing establishment in Vietnam has a certificate of eligibility for drug business and a certificate of compliance with "Good Manufacturing Practice" (GMP) standards in a dosage form suitable for the intended outsourced drug.- For in vitro diagnostic biological products: a manufacturing establishment in Vietnam has a certificate of eligibility for drug business and a certificate of compliance with GMP standards or Vietnamese standards TCVN ISO 13485 or other equivalent standards in a dosage form suitable for the intended outsourced drug.

Outsourcing drugs involves the Outsourcing Assignee performing the work to create products as required by the Outsourcing Assigner, while the Outsourcing Assigner receives the products and pays the remuneration as per the agreement in accordance with the law. The work of the Outsourcing Assignee includes performing one or more stages of the drug manufacturing process (receiving materials, processing stages, packaging, including final packaging and labeling).

For further regulations, refer to Circular 23/2013/TT-BYT which became effective from October 1, 2013.

Thu Ba

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