EEU, Issue 4 August 2016

Draft Customs Code of the EEU is to be submitted for intra-state approval in August 2016

On 26 July 2016 the High Level Working Group dealing with draft Customs Code of the EEU has managed to find an agreement between the parties on the text of the draft Code.

Regulatory framework for pharmaceuticals is to be developed during 2016-2018

The EEU plans to adopt 67 legal instruments regulating pharmaceuticals market within 2016-2018. These instruments will regulate the following issues:

  • Quality and manufacture;
  • Alternative medicine requirements; and
  • Pre-clinical and clinical research of pharmaceuticals.

Regulatory framework for the common market of medical devices established

The Eurasian Economic Commission (EEC) has been completed the creation of the regulatory framework for launching the common market of medical devices. In particular, the Rules for the Registration and Expert Assessment of Quality, Safety and Efficiency of Medical Devices has been officially published.

It is expected that the common market of medical devices in the EEU is to start operating by the end of 2016. However, to parallel registration procedures for medical devices will keep operating until 31 December 2021: the EEU procedure and the national procedures of the EEU Member States. This 6-year transitional period is to allow the manufacturers to bring the production of medical devices to compliance with the new EEU requirements.


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