Procedure for declaration of conformity to traditional drug processing and/or preparation standards in Vietnam

According to the Circular No. 32/2020/TT-BYT of the Ministry of Health of Vietnam, procedure for declaration of conformity to traditional drug processing and/or preparation standards is stipulated as follows:

1. The applicant shall submit a declaration application via the online public service system or by post or in person to the receiving authority (Ministry of Health or Department of Health) according to the following regulations:

- Traditional medicine establishments under management of the Ministry of Health and health units of ministries and central authorities shall submit an application to the Ministry of Health (Traditional Medicine Administration of Vietnam).

- Traditional medicine establishments under management of Departments of Health shall submit an application to Departments of Health.

2. Within 30 days starting from the date written on the acknowledgement of receipt of declaration application, which is made using Form No. 3 in Appendix 3 enclosed therewith, the receiving authority mentioned in Clause 1 Article 5 of the Circular No. 32/2020/TT-BYT shall consider the application and perform the following tasks:

- If the application meets requirements, the receiving authority shall make an announcement on its website using Form No. 06 in Appendix IV enclosed therewith.

- If the application fails to meet requirements, the receiving authority must send a written explanation and request for application amendment to the applicant.

Within 60 days starting from the date written on the request for application amendment, the applicant must send an amended application to the receiving authority.

Within 07 working days starting from the date of receipt of the amended application, the receiving authority shall assess the application and make an announcement on its website if the application meets requirements. Otherwise, it shall send a written explanation and request for application amendment to the applicant. If the applicant fails to amend its application within 60 days starting from the date written on the request for application amendment, its application will be invalidated.

3. In case of change of the person in charge of the processing/preparation operations, area or equipment of a traditional medicine establishment, the establishment shall notify the change to the receiving authority mentioned in Clause 1 Article 5 of the Circular No. 32/2020/TT-BYT in writing. The establishment may process and/or prepare traditional drugs immediately after sending the notification. The receiving authority shall carry out post-inspection of this change.

More details at the Circular No. 32/2020/TT-BYT  of the Ministry of Health of Vietnam, effective from February 2021.

Thuy Tram

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