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On November 10, 2023, the EEC Council Decision No. 108 of September 27, 2023 “On the Labeling of Medicinal Products with Identification Means” came into force. According to this decision, EAEU member states must independently determine the list of medicinal products subject to identification labeling, the date of introduction, and the procedure for labeling in their territory, and notify the EEC at least six months before the introduction of the labeling.<\/span><\/p>\n Main requirements summarized:<\/b><\/p>\n 1.\u00a0 The following medicinal products are subject to labeling:<\/span><\/p>\n 2.\u00a0 Labeling of medicinal products produced in the Union is carried out by the manufacturer, and in the case of importation into the customs territory of the Union, by the holder or owner of the registration certificate by applying identification means.<\/span><\/p>\n For certain medicinal products, the legislation of the member states may establish specific requirements for the application of identification means or a material carrier containing the identification means. Member states must notify the Commission about such medicinal products and the specific requirements before the entry into force of the regulatory legal act establishing these requirements.<\/span><\/p>\n Labeling of remaining medicinal products is not carried out; such products are stored, transported, and sold until their expiration date.<\/span><\/p>\n Labeling does not apply to the following medicinal products:<\/span><\/p>\n Member states independently determine national operators to ensure the functioning of the information system for labeling goods.<\/span><\/p>\n Interaction in cross-border trade between a member state where labeling is introduced and a member state where labeling is not introduced is carried out in accordance with the legislation of the member state where labeling is introduced. 3. The legislation of the Kyrgyz Republic may define requirements for identification means different from those established by this Decision. In this case, medicinal products are not subject to circulation in the territories of member states that have introduced labeling of medicinal products in accordance with this Decision. The Kyrgyz Republic ensures the recognition of identification means that meet the requirements approved by this Decision and applied to medicinal products imported from the territories of member states.<\/span><\/p>\n 3.\u00a0 The Decision indicates that the Republic of Armenia has not confirmed its intention to introduce the labeling of medicinal products in accordance with these rules as of the effective date. However, this does not mean they will not approve the labeling rules for medicinal products according to this Decision in the future.<\/span><\/p>\n From the date of introduction of labeling in their territories by two or more member states, mutual recognition of identification means is ensured in cross-border trade provided that:<\/span><\/p>\n 4.\u00a0 The Decision also approves:<\/span><\/p>\n 5.\u00a0 The identification means include the following data:<\/span><\/p>\n Identification means are formed by issuers of identification means in member states, manufacturers, holders, or owners of registration certificates, or participants in the circulation of goods determined by the legislation of member states.<\/span><\/p>\n Goods are labeled by applying the identification means or a material carrier containing the identification means to the secondary (consumer) packaging or primary packaging (if there is no secondary (consumer) packaging) in a way that does not allow the identification means and\/or material carrier containing the identification means to be separated from the medicinal product packaging without damage.<\/span><\/p>\n When packaging labeled goods into transport (tertiary) packaging, the transport (tertiary) packaging may be labeled with a transport (tertiary) packaging identification means, which contains the identification code of this packaging, with aggregation of the identification means of the goods placed in the transport (tertiary) packaging. The participant in the circulation of goods carries out the aggregation of medicinal products with one Global Trade Item Number and one production batch number.<\/span><\/p>\n The formation of the identification means for transport (tertiary) packaging and labeling of transport (tertiary) packaging is carried out in accordance with GS1 international standards. The identification code of the transport (tertiary) packaging of the medicinal product represents a unique identifier of the transport packaging in the form of a Serial Shipping Container Code.<\/span><\/p>\n 6. The Decision approves the minimum composition of information about a labeled medicinal product contained in the product labeling information system:<\/span><\/p>\n Cratia professionally performs registration of medicinal products and pharmacovigilance in the EAEU. We have deep knowledge in national legislation, necessary experience and resources. To start cooperation or get a consultation, you can contact us at +380680647831, +442081239125, or via email: <\/span>info@cratia.ua<\/span><\/a>.\u00a0<\/span><\/p>\n <\/p>","protected":false},"featured_media":2109,"parent":0,"template":"","meta":[],"news_category":[10],"class_list":["post-2107","news","type-news","status-publish","has-post-thumbnail","hentry","news_category-novosti"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/news\/2107","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/types\/news"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media\/2109"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=2107"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/news_category?post=2107"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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