Belarus

v. 20 – Q4 2021

Market Executive Summary
  • Full right EAEU member: 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 10 June 2011 Law N 243 on goods labelling according to EAEU guidance)
  • 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
  • 2019: EAEU agreements to uniform serialization norms among member countries: resolutions N 72, 127, 128,129, 130, 205 on serialization of shoes, light industry, tiers, cameras, parfums and cloths (N 129 from 2020: milk products). Based on these resolutions: for EAEU countries, who can’t provide their own labelling codes, should be helped with serialization codes by other countries, such as Russia
  • 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
  • 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: Based on the decision of EAEU N 72, the integration of Belarus system and CRPT for shoes labelling with Russian codes took place. This agreement is followed by series of agreements for other categories of products to sell in Russia (light industry, tiers, cameras, parfums, clothes and milk products (the regime of recognition of Russian codes)
  • 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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