Worldwide Regulatory Updates

February 21, 2021

European Union

  • February 21: The European Commission Amendment of Article 22, which provides a derogation for the requirement to decommission packs exported from the EEA to Great Britain for the entirety of 2021, has not yet gone into force because of the procedural 60-day “objection period” within the EU. The amendment could go into force as early as March 14, 2021 and will be retroactive to January 1, 2021.

Kazakhstan

  • February 21: The Kazakh Ministry of Health published guidelines for its pilot on medicinal product marking and traceability, the system for which is operated by Kazakhtelecom. Serialization requirements, including crypto codes and their acquisition, appear nearly identical to those of the Russian Federation. A detailed description of traceability events has not been described, so it is unknown whether the regime will rise to the same level of complexity as those of Russia. GS1 has reported that the pilot will finish in March 2021.

Russia

  • February 21: CRPT reported steady growth of the proportion of labeled medicines packs being sold (and reported as such), up from 3% in July/August 2020 to 32% in December 2020.

United Kingdom

  • February 21: Public consultation is expected within the next 12 months on a UK Falsified Medicines System and the use of data within that system.

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