Clarification by the Drug Administration of Vietnam regarding Decree No. 54/2017/ND-CP

18:02, 10/07/2024

Official Dispatch 4338/QLD-PCD issued by the Drug Administration - Ministry of Health to address some issues of Decree 54/2017/ND-CP on the implementation guidance of the Law on Pharmacy. To be specific::

- Issuance of a Certificate of Eligibility for Pharmaceutical Business - scope of medicine importation for enterprises that have the right to import but not the right to distribute medicines;- Storage and transportation activities of FIE enterprises providing storage and transportation services for medicines and pharmaceutical ingredients after the Law on Pharmacy 2016 and Decree 54 take effect;- Activities of recruiting medicine representatives and providing medicine information to practitioners and pharmacists through the medicine representative of the Representative Office;- Discussion on pricing (price negotiation) between the representative office and FIE enterprises exercising the right to import and domestic pharmaceutical distribution enterprises.

Detailed content of responses can be found at Official Dispatch 4338/QLD-PCD issued on March 14, 2018.

Response to Decree 54/2017/ND-CP

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