Guidance on Periodic Evaluation Procedures for Maintaining Compliance with GACP

To be specific, the sequence and process for the periodic assessment of maintaining GACP compliance are detailed in Article 14 of Circular 19/2019/TT-BYT:

Illustration (source: internet)

Step 1: Within 30 days before the expiration date of the GACP-compliant certificate or the expiration date announced on the Electronic Information Portal of the Department of Traditional and Herbal Medicine Management, the establishment submits one set of documents requesting a periodic assessment of maintaining GACP compliance as stipulated in Article 10 of this Circular to the receiving agency, either in person, by post, or online through the Ministry of Health’s online public service system.

In cases where the establishment does not submit the periodic assessment documents within the stipulated timeframe, within 15 days from the expiration date of the GACP certificate, the receiving agency will issue a written request for the establishment to submit the periodic assessment documents as regulated.

Step 2: Within 45 days from the date the receiving agency issues the written request, the establishment must submit the periodic assessment documents along with an explanation for the delay. If the documents are not submitted within this timeframe, the receiving agency will carry out inspections and audits to assess the maintenance of GACP compliance by the establishment as regulated and draft a record according to Form 4C, Appendix I of this Circular.

The procedure for receiving, appraising the documents, and carrying out the periodic assessment of maintaining GACP compliance complies with the regulations in Clauses 2 and 3, Article 12 of this Circular.

Step 3: After submitting the periodic assessment documents to maintain GACP compliance within the stipulated timeframe in Clause 1 of this Article, the establishment is allowed to continue the production of GACP-compliant medicinal herbs until the results of the periodic assessment are available.

See the full text of the regulations in Circular 19/2019/TT-BYT effective from September 27, 2019.

Thu Ba

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