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anx_III__table__112

Council Regulation (EU) 2025/395 of 24 February 2025 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine · European Union

X.C.IX.005 | “Vaccines”, “immunotoxins”, “medical products”, “diagnostic and food testing kits”, as follows (see List of Items controlled): a. “Vaccines” containing, or designed for use against, items controlled by 1C351, 1C353 or 1C354; b. “Immunotoxins” containing items controlled by 1C351.d; or c. “Medical products” that contain any of the following: 1. “Toxins” controlled by 1C351.d (except for botulinum toxins controlled by 1C351.d.1, conotoxins controlled by 1C351.d.3, or items controlled for CW reasons under 1C351.d.4 or .d.5); or 2. Genetically modified organisms or genetic elements controlled by 1C353.a.3 (except for those that contain, or code for, botulinum toxins controlled by 1C351.d.1 or conotoxins controlled by 1C351.d.3); d. “Medical products” not controlled by X.C.IX.005.c that contain any of the following: 1. Botulinum toxins controlled by 1C351.d.1; 2. Conotoxins controlled by 1C351.d.3; or 3. Genetically modified organisms or genetic elements controlled by 1C353.a.3 that contain, or code for, botulinum toxins controlled by 1C351.d.1 or conotoxins controlled by 1C351.d.3; or e. “Diagnostic and food testing kits” containing items controlled by 1C351.d (except for items controlled for CW reasons under 1C351.d.4 or .d.5). Technical Notes: 1. “Medical products” are: (1) pharmaceutical formulations designed for testing and human (or veterinary) administration in the treatment of medical conditions, (2) prepackaged for distribution as clinical or medical products, and (3) approved by the European Medicines Agency (EMA) either to be marketed as clinical or medical products or for use as research new drug. 2. “Diagnostic and food testing kits” are specifically developed, packaged and marketed for diagnostic or public health purposes. Biological toxins in any other configuration, including bulk shipments, or for any other end-uses are controlled by 1C351.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.