FROM 2021, DRUG DISTRIBUTORS MUST HAVE EQUIPMENT AND COMPUTERS CONNECTED WITH INTERNET
On June 10, 2020, the Ministry of Health issues the Circular No. 9/2020/TT-BYT on amending and supplementing the Circular No. 03/2018/TT-BYT dated February 09, 2020 of the Minister of Health on good distribution practices for drugs and drug materials.
Accordingly, by January 01, 2021, the establishment distributing drugs must be equipped with equipment and computers connected with Internet and manage the distribution of drugs by computer software, connect with Internet, and ensure the control of original and price of purchased and sold drugs.
The Department of Health shall carry out extraordinary evaluation of the compliance with GDP principles with establishments distributing drugs that makes inappropriate explanation or fails to explain reason for not submitting dossiers of requesting for periodic evaluation at request of the Department of Health.
In addition, if the distributing establishment fails to submit the dossier of request for periodic evaluation within the prescribed period, the Department of Health shall issue a written request to the distributing establishment for submission of such dossiers within 15 days from the deadline for submitting that dossiers.
Besides, the Ministry of Health also additional stipulates that the distributing establishment shall submit 01 set of dossier of request for periodic evaluation of the compliance with GDP principles, and pay appraisal charges to the Department of Health in accordance with the Ministry of Finance's regulations on charges for appraisal of conditions and standards for distribution of drugs and drug materials.
This Circular takes effect on July 25, 2020.
