In which cases is it required to apply for a Certificate of Eligibility for Pharmaceutical Business?

16:08, 11/07/2024

Recently, Circular 29/2018/TT-BYT has been issued by the Ministry of Health stipulating regulations on clinical drug trials.

To be specific, during the period between periodic assessments, the clinical trial site must apply for a GCN of eligibility to trade pharmaceuticals if it falls under one of the following cases:

- Change falling under one of the cases stipulated at point b, clause 1, Article 36 of the Pharmaceutical Law;- Change of the trial location for clinical trial sites as stipulated at point c, clause 1, Article 2 of Circular 29;- Change of the position of any technical room serving clinical trials at the same business/trial site;- Addition of any technical room serving clinical trials at a new location at the same business/trial site;- Expansion of any technical room serving clinical trials based on the existing room structure;- Major repairs or structural changes, rearrangements in any technical room serving clinical trials.

More details can be found in Circular 29/2018/TT-BYT, which came into effect on January 01, 2019.

- Thanh Lam -

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