Approval Dossier for Partial Drug Support Program Includes What?

16:03, 11/07/2024

Circular 31/2018/TT-BYT issued by the Ministry of Health prescribes the implementation of a free medication support program for medical facilities to treat patients.

The documentation will vary depending on whether the partial drug support program falls under foreign non-governmental aid, specifically:

In case it does not fall under foreign non-governmental aid, the documentation includes:

- A written request for approval of the partial free drug support program from the pharmaceutical business establishment.- The content of the partial free drug support program submitted for approval.- A copy of the valid Certification of Eligibility for Pharmaceutical Business of the pharmaceutical business establishment.- A certified copy of the Operational License along with the approved scope of expertise of the healthcare facility participating in the program.- A certified copy of the Marketing Authorization or import license of the drug in Vietnam.- A document agreeing to receive and participate in the drug support program from the healthcare facility.- A draft contract between the pharmaceutical business establishment and the healthcare facility.

Refer to the documentation for foreign non-governmental aid at Circular 31/2018/TT-BYT effective from January 01, 2019.

- Thanh Lam -

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