Changes to pharmaceuticals distribution regulations in Belarus

Belarus: Establishment of the Eurasian economic union will significantly influence pharmaceuticals distribution regulations in Belarus

The agreement establishing the Eurasian economic union enters into force on 1 January 2015. The Agreement provides for establishment of a common market in pharmaceuticals and medical products in Belarus, Russia, Kazakhstan and Armenia (the states that have ratified the Agreement) since 1 January 2016. Under the Agreement the parties undertake to conclude an agreement on unified principles and rules on pharmaceuticals and medical products distribution by 1 January 2015. In particular, the new agreement will harmonise and unify member state legislation on distribution of pharmaceuticals and medical products; introduce unified obligatory requirements as to the quality, efficiency and safety of pharmaceuticals and medical products; and unify distribution control regulations on medical products and pharmaceuticals.

As to internal regulations the House of representatives of the Belarusian Parliament has approved a bill on changes to the Law “On pharmaceuticals”. In particular, the bill liberalizes the state registration procedure for pharmaceuticals. When the new law enters into force, a pharmaceutical registration certificate will be issued for five years, and if upon expiry the state registration is confirmed, the certificated will be granted for an indefinite term.

Source: National legal Internet portal of the Republic of Belarus (NLIP) 28.10.2014 4/8023 

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