Periodic Assessment of GDP Compliance Maintenance at Distribution Facilities

According to Circular 03/2018/TT-BYT, the dossier for requesting a periodic evaluation of the maintenance of GDP compliance includes:

- Application for periodic evaluation of the maintenance of GDP compliance;- Updated technical documentation on the facilities, technical conditions, and personnel of the distribution establishment (if there are changes);- A summary report on the drug and raw material distribution activities of the establishment in the past 3 years from the time of the previous evaluation (excluding sudden assessments, inspections, and examinations by the Ministry of Health and the Department of Health) to the date of the request for periodic evaluation.

The periodic evaluation of maintaining compliance with Good Distribution Practices (GDP) for drugs and drug materials is regulated as follows:

- The periodic evaluation time for maintaining GDP compliance at the distribution establishment (including non-commercial distribution establishments and establishments dealing with specially controlled drugs) is 3 years from the end date of the previous evaluation (excluding sudden assessments, inspections, and examinations by the Ministry of Health and the Department of Health).

- In November each year, the Department of Health announces on its website the periodic evaluation plan for maintaining GDP compliance of the distribution establishments for the following year.

- Based on the periodic evaluation plan published by the Department of Health, the distribution establishment must submit the application for periodic evaluation to the Department of Health at least 30 days before the evaluation date as per the published plan.

Example: If the expected evaluation date for Distribution Establishment A is August 18, 2018, Distribution Establishment A must submit the application for evaluation to the Department of Health before July 18, 2018.

- If the distribution establishment does not submit the application for periodic evaluation within the specified time limit, within 10 days from the due date for submission, the Department of Health will issue a document requesting the distribution establishment to provide an explanation for not submitting the application for periodic evaluation.

- Within 30 days from the date the Department of Health issues a document requesting the distribution establishment to explain the reason for not submitting the application for periodic evaluation, if the distribution establishment does not submit the application according to regulations, the Department of Health will revoke the Certificate of Eligibility for Pharmaceutical Business of the distribution establishment as per Clause 2, Article 40 of the Pharmaceutical Law or issue a document requesting the cessation of distribution activities for non-commercial distribution establishments.

- After submitting the application for periodic evaluation of maintaining GDP compliance within the specified time, the distribution establishment may continue its distribution activities of drugs and drug materials as per the scope defined in the Certificate of Eligibility for Pharmaceutical Business or the GDP Certificate for non-commercial distribution establishments from the date of dossier submission until the periodic evaluation result is available.

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

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