Guidelines on the Scope of Business Recorded in the GPP, GDP Certificates

08:58, 11/07/2024

On May 16, 2018, the Drug Administration of Vietnam, Ministry of Health, issued Official Dispatch No. 8590/QLD-KD providing guidance on the scope of business recorded in the Certificate of Eligibility for Pharmaceutical Business and Good Practice Certificates.

The Drug Administration Department provides guidelines on the interpretation in the business scope section for the Certificates of Good Practice issued before July 1, 2017, as follows:

- If it specifies drugs (e.g., wholesale of drugs under cold storage conditions), it is understood to include the wholesale of finished drugs, vaccines, medical biological products, and drug ingredients.- If it specifies finished drugs (e.g., wholesale of finished drugs under cold storage conditions), it does not include vaccines, medical biological products, or drug ingredients.

In case of receiving a request from a pharmaceutical business establishment regarding the confirmation of the business scope as stated in the Certificate issued before July 1, 2017, the Department of Health is requested to provide a written response to the establishment based on the business scope that has been evaluated and shown in the Establishment Evaluation Records.

Refer to the detailed guidelines in Official Dispatch 8590/QLD-KD.

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