What are regulations on packaging and labeling of harvested and extracted herbal materials before packaging in Vietnam?

What are regulations on packaging and labeling of harvested and extracted herbal materials before packaging in Vietnam? - image from internet

According to the regulations in Clause 4.3, Chapter IV, Appendix III of Circular 19/2019/TT-BYT (effective from 27/09/2019), the packaging and labeling of harvested and extracted herbal materials before packaging are as follows:

- Measures must be taken to ensure that packaging is done quickly and minimizes the risk of cross-contamination, mix-up, or substitution during labeling and packaging activities. Mechanical separation must be in place to prevent confusion between products and packaging when packaging different products in the same area. The product name and batch number must be displayed in the packaging area.

- The production line must be thoroughly cleaned before packaging activities to ensure that no unnecessary products, materials, or documents from previous operations remain on the line.

- Label samples and packaging samples that have been printed must be kept in the batch records. Separate storage areas must be designated for unfinished products awaiting release. Printing operations (e.g., batch numbers, expiration dates) must be carried out independently or during the packaging process and must be checked and recorded. Hand printing must be regularly verified.

- The products and packaging materials used must be checked upon delivery to the packaging department to ensure the correct quantity and type.

- The printed and embossed information on the packaging must be easily visible and resistant to fading or erasure.

- Control must be maintained during the process to ensure the accurate operation of electronic code readers, label counters, or similar devices. Strict control is required for the use of cut labels and when performing external packaging printing. The use of roll labels limits confusion compared to cut labels.

- Minimum process controls during packaging must include: the form of the packaging; the correct use of packaging for the product; the accuracy of printing; and the proper functioning of the production line.

- Samples taken out of the packaging line should not be returned. Any abnormal product samples should only be reintroduced into the production line after being inspected, reviewed, and approved by authorized personnel.

- Significant differences or abnormalities in comparing intermediate products and printed packaging materials and the quantity of production units need to be investigated and appropriately explained before release.

- Procedures for disposal or return to stock must be established for pre-printed or batch-encoded packaging. Disposal or return must be documented.

Above are the regulations for packaging and labeling of harvested and extracted herbal materials before packaging.

Best regards!