{"id":24168,"date":"2026-07-01T09:49:27","date_gmt":"2026-07-01T07:49:27","guid":{"rendered":"https:\/\/cinmed.me\/obavjestenje-za-nosioce-dozvole-za-veterinarski-lijek-i-veledrogerije-koje-se-bave-uvozom-veterinarskih-ljekova\/"},"modified":"2026-07-01T10:11:53","modified_gmt":"2026-07-01T08:11:53","slug":"obavjestenje-za-nosioce-dozvole-za-veterinarski-lijek-i-veledrogerije-koje-se-bave-uvozom-veterinarskih-ljekova","status":"publish","type":"post","link":"https:\/\/cinmed.me\/en\/obavjestenje-za-nosioce-dozvole-za-veterinarski-lijek-i-veledrogerije-koje-se-bave-uvozom-veterinarskih-ljekova\/","title":{"rendered":"Notice to marketing authorisation holders for veterinary medicinal products and wholesale distributors engaged in the import of veterinary medicinal products"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"24168\" class=\"elementor elementor-24168 elementor-24158\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6a788cb0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6a788cb0\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4a205130\" data-id=\"4a205130\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7c8fb51d elementor-widget elementor-widget-text-editor\" data-id=\"7c8fb51d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Institute for Medicines and Medical Devices hereby informs marketing authorisation holders for veterinary medicinal products and wholesale distributors engaged in the import of veterinary medicinal products that, in view of the implementation of the new regulatory framework governing veterinary medicinal products, and with the aim of strengthening measures to combat antimicrobial resistance (AMR) and ensuring the responsible and prudent use of antimicrobials in veterinary medicine, particular attention will henceforth be given to the assessment of applications concerning the import of veterinary medicinal products containing one or more antimicrobial substances, especially where such products are intended for the treatment of food-producing animals.<\/p>\n<p>\u00a0<\/p>\n<p>Antimicrobial resistance represents one of the most significant global public health challenges. Accordingly, the international and European regulatory framework promotes the responsible and prudent use of antimicrobial medicinal products, based on the principle that their use should be limited to cases where it is justified and supported by a favourable benefit-risk assessment.<\/p>\n<p>\u00a0<\/p>\n<p>Particular attention will be paid to veterinary medicinal products containing combinations of two or more antimicrobial substances, given that the use of such combinations must be clearly justified on scientific and therapeutic grounds and must not contribute to unnecessary exposure of animals to antimicrobial medicinal products or increase the risk of the development of antimicrobial resistance.<\/p>\n<p>\u00a0<\/p>\n<p>Accordingly, applicants may be requested to submit additional documentation in support of applications for the placing on the market of veterinary medicinal products containing antimicrobial substances, including, in particular:<\/p>\n<p>\u00a0<\/p>\n<ul>\n<li>a justification of the composition of the veterinary medicinal product, especially where the product contains a combination of two or more antimicrobial substances;<\/li>\n<li>a scientific and therapeutic justification of the proposed indication(s), including consideration of the available guidelines on the responsible use of antimicrobial medicinal products;<\/li>\n<li>an assessment of the need for placing the veterinary medicinal product on the market in Montenegro;<\/li>\n<li>a justification of the proposed quantities to be placed on the market, taking into account the authorised indications, target animal species and the anticipated level of use;<\/li>\n<li>any other information that may be relevant for the assessment of the benefit-risk balance and the potential impact on antimicrobial resistance.<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<p>This approach is based on the principles laid down in the legislation governing veterinary medicinal products, as well as internationally recognised guidelines on the responsible use of antimicrobial medicinal products, according to which the use of antimicrobials should be restricted to situations where there is a clearly established therapeutic need, with particular caution being exercised in the use of combinations of antimicrobial substances.<\/p>\n<p>\u00a0<\/p>\n<p>Applicants should note that the availability of a veterinary medicinal product in other markets or its prior authorisation in other countries will not, in itself, constitute sufficient grounds for granting a marketing authorisation in Montenegro where the need for placing the product on the Montenegrin market has not been adequately justified from the perspective of the responsible use of antimicrobial medicinal products and the risk of the development of antimicrobial resistance.<\/p>\n<p>\u00a0<\/p>\n<p>Applicants are requested to take the above into account when preparing future applications and supporting documentation, in order to facilitate an efficient assessment process in compliance with the applicable regulatory requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The Institute for Medicines and Medical Devices hereby informs marketing authorisation holders for veterinary medicinal products and wholesale distributors engaged in the import of veterinary medicinal products that, in view of the implementation of the new regulatory framework governing veterinary medicinal products, and with the aim of strengthening measures to combat antimicrobial resistance (AMR) and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":24174,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-24168","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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