The official letter 12595/QLD-KD about implementation Decree 54/2017/ND-CP

The official letter 12595/QLD-KD
The official letter 12595/QLD-KD
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The official letter 12595/QLD-KD about implementation Decree 54/2017/ND-CP


Independence FreedomHappiness

No.: 12595/QLD-KD

About: implementation Decree 54/2017/ND-CP


                            Hanoi, 18 August, 2017


To: Pharmaceutical companies


On 08 May, 2017, Government issued Decree 54/2017/ND-CP about guide implementation pharma law. In this decree, article 91, it gives the provision of the law about business operation scope of such companies that are foreign invested enterprise (it is called FIE). These FIE establishments are not allowed to perform activities directly related to the distribution of drugs and drug raw materials in Viet Nam, exempt for those are manufactured in Viet Nam by these FIE establishments. These activities directly related to the distribution shall be included transportation, providing storage service of drugs & drugs raw materials.

Drug Administration request companies the following:

– Read carefully the Decree 54/2017/ND-CP to make the decision for the business partner in distribution drugs and drugs raw materials in Viet Nam which it is met the provision in Decree 54/2017/ND-CP.

– Incases drugs & drugs raw materials which are manufactured/or be registered/or are supplied by establishments; but they are being distributed, transported and be used storage service by FIE establishments; then company should consider for change relevant business partner that meet the provision of law. Kindly send the report of this matter to Dug Administration before 31/08/2017.

The Drug Administration informs the units to acknowledge and implement.

                                                                            On behalf of Drug Administration

                                                                                      Vice Drug Administration

                                                                                          (Signed and sealed)

                                                                                             DO VAN DONG.

The official letter 12595/QLD-KD about implementation Decree 54/2017/ND-CP

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