{"id":2403,"date":"2025-01-13T22:44:55","date_gmt":"2025-01-13T21:44:55","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2403"},"modified":"2025-02-26T11:01:32","modified_gmt":"2025-02-26T10:01:32","slug":"positioning-and-compliance-audit-of-dadfms","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/positioning-and-compliance-audit-of-dadfms\/","title":{"rendered":"Positioning and compliance audit of DADFMS"},"content":{"rendered":"\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p style=\"font-size:18px\">A positioning audit is a key step in bringing a DADFMS to market. it allows evaluating the risk of reclassification as a medicine and ensuring that the product meets european regulatory requirements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:25px\"><strong><strong><strong><strong><strong><strong><strong>key points in the audit<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">the compliance audit examines several aspects:<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li style=\"font-size:18px\"><strong>Feasibility of positioning:<\/strong>\u00a0Verification that the product meets the criteria of an FSMP and not those of a food product or a food supplement, among others.<\/li>\n\n\n\n<li style=\"font-size:18px\"><strong>Evaluation of the risk of reclassification as a medicine<\/strong>:\n<ul class=\"wp-block-list\">\n<li>If a product has curative or preventive properties, it risks being reclassified as a medicinal product by function.<\/li>\n\n\n\n<li>A product, even if marketed as an FSMP, must not claim a pharmacological effect.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li style=\"font-size:18px\"><strong>Analysis of claims used:<\/strong>\u00a0All communication must comply with the framework of authorized nutritional and health claims.<\/li>\n<\/ol>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:30px\"><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">The positioning audit is an essential step to ensure FSMP compliance and prevent regulatory sanctions.\u00a0A thorough analysis of the composition, indication, target population, and commercial positioning helps guarantee a fully compliant market placement.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section id=\"block_49bf9951f68af773158b2f958dbe6f4d\" class=\"stafe-blocks-faq sbfaq section section_faq-block section_faq-bg-color\" style=\"background-color: #f8f9fa;\">\n    <script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"<h3 style=\\\"font-size: 20px;\\\"><span class=\\\"third-title\\\">Why can a DADFMS be reclassified as a medicine?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><span class=\\\"fourth-title\\\">If a DADFMS claims curative or preventive properties, it may be considered a medicine and subject to stricter regulations.<br \\\/>\\n<\\\/span><\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3 style=\\\"font-size: 20px;\\\"><span class=\\\"third-title\\\">What are the key elements of a compliance audit for DADFMS?<br \\\/>\\n<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The audit ensures that the product&#8217;s composition effectively meets the nutritional needs of the target population, guaranteeing compliance with regulatory positioning.<\\\/p>\\n\"}}]}<\/script>\n    <div class=\"faq-block_container\">\n        <div class=\"container\">\n                            <div class=\"faq_title\">\n                    <h2 style=\"text-align: center; font-size: 30px;\">Your frequently asked questions about the DADFMS compliance audit<\/h2>\n                <\/div>\n            \n                            <div class=\"faq_accordion\">\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3 style=\"font-size: 20px;\"><span class=\"third-title\">Why can a DADFMS be reclassified as a medicine?<\/span><\/h3>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p><span class=\"fourth-title\">If a DADFMS claims curative or preventive properties, it may be considered a medicine and subject to stricter regulations.<br \/>\n<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3 style=\"font-size: 20px;\"><span class=\"third-title\">What are the key elements of a compliance audit for DADFMS?<br \/>\n<\/span><\/h3>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p>The audit ensures that the product&#8217;s composition effectively meets the nutritional needs of the target population, guaranteeing compliance with regulatory positioning.<\/p>\n                            <\/div>\n                        <\/div>\n                                    <\/div>\n                                <\/div>\n    <\/div>\n<\/section>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>A positioning audit is a key step in bringing a DADFMS to market. it allows evaluating the risk of reclassification as a medicine and ensuring that the product meets european regulatory requirements. key points in the audit the compliance audit examines several aspects: Conclusion The positioning audit is an essential step to ensure FSMP compliance [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1956,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[75,276],"tags":[],"class_list":["post-2403","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-specific-groups-of-foods-en"],"acf":[],"yoast_head":"<!-- This site is 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