Dossier Serving as the Basis for Assessing Compliance with GPD

23:47, 11/07/2024

Good Distribution Practice (GDP) for drugs and drug substances is a set of principles and standards for distributing drugs and drug substances to ensure their quality is maintained through comprehensive control of activities during the distribution process and to prevent the infiltration of unauthorized drugs and drug substances into the distribution system.

According to the provisions of Article 5 of Circular 03/2018/TT-BYT, the dossier serving as the basis for evaluating GDP compliance for distribution establishments is the application for the Certificate of Eligibility for Pharmaceutical Business (to be submitted when applying for the Certificate of Eligibility for Pharmaceutical Business; the distribution establishment does not need to submit this dossier again) as stipulated in Article 38 of the Law on Pharmacy and Article 32 of Decree 54/2017/ND-CP.

In the case of drug distribution establishments requiring special control, regulations under Article 38 of the Law on Pharmacy and Article 49 of Decree 54/2017/ND-CP shall be followed.

For technical documentation regarding the distribution establishment, it shall be presented according to the overall dossier guidelines as specified in Form No. 05 of Annex IV attached to Circular 03/2018/TT-BYT or the updated overall dossier in case of expanding the scope of activities.

The dossier serving as the basis for evaluating GDP compliance for non-commercial distribution establishments includes:

- Application for GDP compliance evaluation;- Technical documentation regarding the distribution establishment presented according to the overall dossier guidelines.

In the case where the distribution establishment requests the issuance of the GDP Certificate along with the Certificate of Eligibility for Pharmaceutical Business, the distribution establishment must clearly state this content in the Application for the Certificate of Eligibility for Pharmaceutical Business.

See also: Circular 03/2018/TT-BYT, effective March 26, 2018.

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