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25.11.2021 (Обновлено: 18.02.2022 11:29)

EEC improves customs regulations and simplifies marketing authorization of medicines

During its meeting held on November 25 under the chairmanship of Galiya Dzholdybaeva, Director of the Business Development Department, Deputy Head of the Working Group, the Eurasian Economic Commission's working group on regulatory impact assessment for the Eurasian Economic Commission's draft decisions addressed the issues of customs regulations and circulation of medicines. The group discussed a draft decision of the EEC Board providing a possibility to indicate information about a foreign authorized economic operator in the declaration for goods.

In the course of concluding international treaties on the mutual recognition of authorized economic operators with third countries, this decision will facilitate the simplification of the conditions for conducting foreign economic activity.

A draft decision of the EEC Board was considered to regulate the mechanism for customs declaring procedure for bona fide purchasers of goods that were illegally moved across the Union's customs border or were not released by the customs authorities as required by law.

The working group supported the EEC Board's draft decision contributing to the elimination of the duplicate requirement for placing under the customs procedure of customs transit of processed products exported from the Union as part of the customs procedure of re-export. In addition, the working group focused on the need to additionally study the issue of extending similar simplifications not only to processed products but also to waste and residues formed as part of goods processing within the Union's customs territory.

The working group also considered the draft amendments to the Rules for Marketing Authorization and Expert Assessment of Medicinal Products for Human Use. These amendments will expand the possibilities of electronic document flow and remote procedures in assessing the quality of medicinal products and introduce three new-type procedures for simplified and accelerated access of medicinal products to the single pharmaceutical market of the Union (conditional marketing authorization, marketing authorization in exceptional cases and accelerated examination of documents).