06 Changes Required to Notify and Request for Certificate of Eligibility for Pharmaceutical Business

05:36, 11/07/2024

This is an important content stipulated in Circular 36/2018/TT-BYT regulating Good Storage Practices for drugs and drug materials.

To be specific:, Circular 36 stipulates that if one of the following cases applies, the storage facility, after making changes, must carry out procedures to apply for a Certificate of eligibility for pharmaceutical business or report the change. To be specific:

- Changes falling under one of the cases specified in point b, clause 1, Article 36 of the Law on Pharmacy;- Change in the location of the storage warehouse at the same business location;- Adding a warehouse at a new location at the same business location;- Expanding the storage warehouse based on the existing warehouse structure;- Major repairs or changes in the structure and layout of the storage warehouse;- Changing the auxiliary system or changing the design principles, operating the utility system that affects the storage requirements and conditions.

Refer to the related regulations in Circular 36/2018/TT-BYT effective from January 10, 2019.

- Thanh Lam -

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