Belarus

v. 19 – Q3 2021

Market Executive Summary
  • Anticipating regional effort to develop legislation on falsified medicine under the umbrella of Eurasian Economic Union (Belarus, Kazakhstan, Russia, Kyrgyzstan, Tajikistan, Uzbekistan), to align with Russian Federation.
  • Following EAEU rules for medicines registration and assessments (from 2018)
  • 03 November 2016: Decision 76 of EAEU On approval of the Requirements for the labeling of medicinal products for medical use and veterinary medicinal products
  • March 2019: Agreement of EAEU countries on medicines labeling by identification means
  • August 2019: EUEA meeting to uniform serialization norms among member countries according to Russia example. Further discussions have been foreseen.
  • The procedure for accelerated and simplified registration of medicinal products has been introduced, and significant changes have been made to the system of the state quality control. The possibility of using a sticker in Russian or Belarusian for labeling of product packaging has been determined.
  • The procedure for accelerated and simplified registration of medicinal products has been introduced, and significant changes have been made to the system of the state quality control. The possibility of using a sticker in Russian or Belarusian for labeling of product packaging has been determined.
  • The EAEU extended the mutual recognition of GMP certificates issued by EAEU member states; the EAEU Pharmacopoeia has been approved.
  • According to CRPT (Russian Operator) website information: as per the decision of the EAEU, operators of countries that have introduced mandatory labelling must provide Data Matrix codes to operators of states that have not yet introduced such mandatory labelling.
  • State Information System of Goods’ Labelling – GIS “Electronic Sign”, similar to CRPT in Russia is being implemented, though medicines are not in scope for the moment.
  • Integration with CRPT for labelling of shoes, parfums, tires, light industry: Belarus companies get Russian labelling codes.
Key Dates
  • September 1, November 1, December 1, 2021: Mandatory labelling of large category of goods in Belarus using 2D Data Matrix, though medicines are not yet in scope
  • June 5, 2020: a simplified procedure for state registration of medicinal products came into force
  • August 8, 2019: Decision of EAEU N 72 on integration of Belarus system and CRPT for shoes labelling with Russian codes. This agreement is followed by series of agreements for other categories of products to sell in Russia.
  • November 3, 2016: Decision 76 of EAEU On approval of the Requirements for the labeling of medicinal products for medical use and veterinary medicinal products

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