Guidelines on the Procedure for Evaluating Changes and Additions to GACP Compliance

To be specific, the procedures for evaluating, processing results of evaluation changes, and supplementing GACP compliance are implemented according to the provisions of Article 16 of Circular 19/2019/TT-BYT as follows:

Illustration (source internet)

Step 1: The facility requesting the evaluation of changes and supplementation of GACP compliance submits 01 dossier and 01 CD or USB containing the corresponding documents as prescribed in Article 11 of this Circular, along with the appraisal fee as stipulated by the Minister of Finance, to the Department of Traditional Medicine Management (receiving agency) by direct submission, postal mail, or online submission through the Ministry of Health's online public service system.

Step 2: Upon receiving a complete dossier as prescribed, the receiving agency issues a Dossier Receipt according to Form No. 02 in Appendix I issued together with this Circular. In case of an incomplete dossier, the receiving agency requests the facility to supplement the complete dossier if submitted directly, or within 10 days, the receiving agency issues a written request for the facility to supplement the complete dossier if submitted by postal mail or online.

The facility may implement the changes or supplementation immediately after the receiving agency issues the Dossier Receipt if it falls into one of the following categories: changes or supplementation of the establishment decision or business condition certificate, or changes and supplementation of the organizational structure and personnel of the facility, provided the requirements and conditions of the department in charge of the technical cultivation and exploitation of medicinal herbs of the facility are met.

Step 3: Within 01 month from the date of receiving a complete, valid dossier, the receiving agency conducts dossier appraisal and on-site evaluation at the facility according to the provisions of Clause 2 and Clause 3 of Article 12 of this Circular if one of the following cases applies:

- Changes or supplementations to the cultivation, exploitation area of medicinal herbs in regions with the same soil and climate conditions;- Changes in seed, seed selection, and propagation processes;- Changes in the cultivation process of medicinal herbs: fertilizer/feed ratio, fertilization/nutrient supplementation timing;- Changes in the harvesting and processing process of medicinal herbs: harvesting time, harvesting methods, processing conditions (temperature, humidity, excipient/additive ratio);- Other changes that seriously affect the quality of medicinal herbs;- Changes or supplementations not specified in Clause 3 of this Article.

If on-site evaluation is required as stipulated in Clause 4 of this Article, the handling of evaluation results for changes and supplementation of GACP compliance is conducted according to Article 13 of this Circular.

See additional regulations in Circular 19/2019/TT-BYT effective from September 27, 2019.

Thu Ba

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE