Procedure for Assessing Good Distribution Practice Compliance

20:15, 10/07/2024

The Ministry of Health has just issued Circular 03/2018/TT-BYT stipulating good distribution practices for medicines and medicinal ingredients.

The pharmaceutical distribution establishment shall submit one dossier in accordance with Article 5 of Circular 03/2018/TT-BYT, along with the dossier appraisal fee to the Department of Health.

The Department of Health shall receive and appraise the dossier based on the following regulations:

- For establishments distributing drugs containing addictive substances, psychotropic substances, and pre-substance-containing drugs: Implement in accordance with Clauses 2, 3, 4, 5, and 6 of Article 50 of Decree 54/2017/ND-CP;- For establishments distributing toxic drugs, toxic raw materials for drugs; drugs, and substances listed in the banned substances list: Implement in accordance with Clauses 2, 3, 4, and 5 of Article 51 of Decree 54;- For establishments not falling under the two cases mentioned above: Implement in accordance with Clauses 2, 4, and 6 of Article 33 of Decree 54.

Finally, within a maximum period of 20 days from the date of receipt of a valid dossier, the Department of Health shall notify and conduct an actual evaluation at the distribution establishment.

Circular 03/2018/TT-BYT takes effect from March 26, 2018.

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