02 cases where the ordering facilities have the right to register for marketing authorization of medicine in Vietnam

02 cases where the ordering facilities have the right to register for marketing authorization of medicine in Vietnam

Ordering facilities have the right to register for marketing authorization of medicine when:

- They possess certificate of eligibility for pharmaceutical business which permits them to: manufacture, trade, export, or import medicine, medicinal ingredients in regard to Vietnamese Ordering facilities;

- They possess legitimate documents issued by foreign competent authority and granting them permission to: manufacture, trade, export, or import medicine, medicinal ingredients and license to establish representative office in Vietnam in regard to foreign Ordering facilities.

Responsibilities of ordering facilities in Vietnam

Ordering facilities have the responsibility to:

- Comply with Article 3 of Circular 08/2022/TT-BYT

- Provide contract facilities with:

= Partial or total ingredients, materials, and technical specifications including production procedures, quality standards, testing methods for starting ingredients, semi-finished products, finished products, and excipients for the purpose of contract manufacturing;

= Other documents relating to market authorization registration of contract manufactured medicine and contract manufacturing of medicine.

- Be responsible for legitimacy and authenticity of intellectual property of contract manufactured medicine, ingredients, materials, production procedures, and technical specifications transferred to contract facility;

- Cooperate with applicants in staying up-to-date with quality standards of medicine and medicinal ingredients;

- Examine and supervise contract facility regarding production of contract manufactured medicine with the right transferred ingredients, materials, specifications, documents, and approved medicine marketing authorization in order to properly adhere to manufacturing contract and comply with GMP;

- Assume responsibility for quality, safety, and efficacy of contract manufactured medicine;

-  File report or cooperate with applicants of contract manufactured medicine (if the owner does not register for marketing authorization) in filing report on monitoring and assessment of safety and efficacy of contract manufactured medicine;

- Inform contract facilities, ordering facilities and facilities registering for marketing authorization

More details can be found in Circular 16/2023/TT-BYT effective from October 1, 2023, replacing Circular 23/2013/TT-BYT.

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