INSPECTION OF COMPLIANCE DEGREE WITH GDP PRINCIPLES IN 03 DEGREES
In accordance with the Circular No. 03/2018/TT-BYT of the Ministry of Health dated February 09, 2018 on good distribution practices for pharmaceutical products and pharmaceutical starting materials:
The degree of compliance of a distributor with GDP principles shall be assessed and includes GDP degree 1 distributor; GDP degree 2 distributor and GDP degree 3 distributor.
Within 05 days from the date of issuing the certificate of eligibility for pharmacy business or the certificate of GDP compliance, the Department of Health shall publish the following information on the website of the Department of Health: name and address of the distributor; full name of the pharmacist, pharmacy practice certificate number; number of the certificate of eligibility for pharmacy business and certificate of GDP compliance (if any); expiry date of the inspection of compliance with GDP principles…
A periodic inspection of maintenance of compliance with GDP principles at a distributor shall be carried out every 03 years from the end of the previous inspection. According to the periodic inspection plan published by the Department of Health, the distributor shall submit an application for the periodic inspection prescribed in Clause 7 of this Article to the Department of Health at least 30 days before the date of carrying out the inspection according to the published plan.
This Circular takes effect on March 26, 2018.
