Proposal for Evaluating Medicinal Materials for GACP Certification in Which Case?

Article 8 of Circular 19/2019/TT-BYT stipulates that establishments requesting the assessment of medicinal materials achieving GACP in the following cases:

Illustration (source: internet)

- Establishments with medicinal materials that have not been assessed, announced to achieve GACP, or issued a Certificate of Medicinal Materials Achieving GACP or a Receipt of Announcement of Establishment Achieving GACP, which remains valid prior to the effective date of this Circular;- Establishments with medicinal materials that have been announced or issued a Certificate of Medicinal Materials Achieving GACP but have changes or additions to the locations of cultivation, harvesting, exploitation of medicinal materials in different geographic areas, soil types, climates compared to the previously achieved GACP areas, or complete changes to the processes of cultivation, harvesting, exploitation, processing of medicinal materials.

Establishments requesting the assessment for maintaining compliance with GACP when the announced validity period on the website of the Department of Traditional Medicine and Pharmacy Management or the GACP Certificate expires.

Establishments requesting the assessment for changes or additions to comply with GACP within the valid period of the announcement or GACP Certificate when there are changes or additions except for changes or additions as stipulated in Point b, Clause 1, Article 8.

Moreover, this Circular stipulates the withdrawal of the GACP Certificate or removal of the announcement of achieving GACP content posted on the website of the Department of Traditional Medicine and Pharmacy Management in the following cases:

- Establishments cultivating or exploiting medicinal materials do not comply with GACP principles and standards;- Establishments do not implement corrective actions within the stipulated period, or delay corrective actions, or intentionally do not correct.

The validity period of the announcement of medicinal materials achieving GACP or the GACP Certificate is 03 years from the date of announcement or issuance.

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

Thu Ba

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