{"id":313271,"date":"2023-11-16T05:27:30","date_gmt":"2023-11-16T10:27:30","guid":{"rendered":"https:\/\/platohealth.ai\/hpra-guidance-on-fees-authorization-regdesk\/"},"modified":"2023-11-18T01:54:47","modified_gmt":"2023-11-18T06:54:47","slug":"hpra-guidance-on-fees-authorization-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/hpra-guidance-on-fees-authorization-regdesk\/","title":{"rendered":"HPRA Guidance on Fees: Authorization &#8211; RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<div id=\"et-boc\" class=\"et-boc\">\n<div class=\"et-l et-l--post\">\n<div class=\"et_builder_inner_content et_pb_gutters3\">\n<div class=\"et_pb_section et_pb_section_0 et_section_regular\">\n<div class=\"et_pb_row et_pb_row_0\">\n<div class=\"et_pb_column et_pb_column_1_2 et_pb_column_0 et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_module et_pb_text et_pb_text_0 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<p><span>The article addresses the aspects related to the fees payable in the context of authorization for medical device manufacturers, wholesalers, and distributors.&nbsp;<\/span><\/p>\n<\/div><\/div>\n<p> <!-- .et_pb_text --> <\/div>\n<p> <!-- .et_pb_column --><\/p>\n<div class=\"et_pb_column et_pb_column_1_2 et_pb_column_1 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_image et_pb_image_0\"> <span class=\"et_pb_image_wrap \"><img decoding=\"async\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2023\/11\/hpra-guidance-on-fees-authorization-regdesk.jpg\" alt=\"HPRA Guidance on Wholesale Distribution Authorizations\" title=\"ireland-flag-std_2\" data-et-multi-view=\"{&quot;schema&quot;:{&quot;attrs&quot;:{&quot;desktop&quot;:{&quot;src&quot;:&quot;https:\/\/platohealth.ai\/wp-content\/uploads\/2023\/11\/hpra-guidance-on-fees-authorization-regdesk.jpg&quot;,&quot;alt&quot;:&quot;HPRA Guidance on Wholesale Distribution Authorizations&quot;,&quot;title&quot;:&quot;ireland-flag-std_2&quot;,&quot;srcset&quot;:&quot;https:\/\/platohealth.ai\/wp-content\/uploads\/2023\/11\/hpra-guidance-on-fees-authorization-regdesk.jpg 800w, https:\/\/platohealth.ai\/wp-content\/uploads\/2023\/11\/hpra-guidance-on-fees-authorization-regdesk-2.jpg 150w, https:\/\/platohealth.ai\/wp-content\/uploads\/2023\/11\/hpra-guidance-on-fees-authorization-regdesk-3.jpg 300w, https:\/\/platohealth.ai\/wp-content\/uploads\/2023\/11\/hpra-guidance-on-fees-authorization-regdesk-4.jpg 768w, https:\/\/www.regdesk.co\/wp-content\/uploads\/2019\/05\/ireland-flag-std_2-75x75.jpg 75w&quot;,&quot;sizes&quot;:&quot;(max-width: 800px) 100vw, 800px&quot;},&quot;tablet&quot;:{&quot;src&quot;:&quot;&quot;}}},&quot;slug&quot;:&quot;et_pb_image&quot;}\"><\/span> <\/div>\n<\/p><\/div>\n<p> <!-- .et_pb_column --> <\/div>\n<p> <!-- .et_pb_row --><\/p>\n<div class=\"et_pb_row et_pb_row_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Table_of_content\"><\/span>Table of content<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<p><span>The <\/span><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.hpra.ie\/\"><span>Health Products Regulatory Authority<\/span><\/a><span> (HPRA), the Irish agency responsible for the regulation of healthcare products, has published a guidance document dedicated to fees payable in the context of registration and authorization of different healthcare products including, inter alia, medical devices intended to be marketed and used in the country. <\/span><span><br \/><\/span><span><br \/><\/span><span>The document provides an overview of the approach to be applied when determining the fees payable by the interested parties and also provides additional clarifications and recommendations to be taken into consideration to ensure compliance with the existing legal framework.&nbsp;<\/span><\/p>\n<p><span>The authority also reserves the right to make changes to the provisions of the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.&nbsp;<\/span><\/p>\n<p><span>The scope of the guidance covers, inter alia, the fees payable in respect of authorization for various parties involved in operations with healthcare products.<\/span><\/p>\n<\/div><\/div>\n<p> <!-- .et_pb_text --> <\/div>\n<p> <!-- .et_pb_column --> <\/div>\n<p> <!-- .et_pb_row --><\/p>\n<div class=\"et_pb_row et_pb_row_2\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_3 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"ManufacturersImporters_Authorisations_MIA\"><\/span><b>Manufacturers\u2019\/Importers\u2019 Authorisations (MIA)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span>Manufacturers and importers seeking authorization to operate in the country must adhere to specific codes laid out by the HPRA.<\/span><\/p>\n<ul>\n<li><b>Code 310<\/b><span> which is the most important one in the MIA application process. If a manufacturer already possesses an MIA for medicinal products and then seeks another for investigational medicinal products, the fee for the latter is halved, providing a financial incentive for research and development.<\/span><span><br \/>\n<\/span><\/li>\n<li><b>Maintenance Fees (Codes 311-314)<\/b><span> are recurring annual charges. <\/span><span><br \/><\/span><span>The size of the facility and the number of \u201crelevant employees\u201d (those involved in production, quality control, and engineering) influence these fees. <\/span><span><br \/><\/span><span>It is also important to mention that if a manufacturer produces both human and veterinary medicinal products, the combined number of relevant employees dictates the site size. Such manufacturers face a 1.5x fee compared to a single authorization.<\/span><span><br \/>\n<\/span><\/li>\n<li><b>Code 349<\/b><span> is specifically tailored for homoeopathic manufacturers.<\/span><span><br \/><\/span><\/li>\n<\/ul>\n<p><span>Variations to Authorisations <\/span><b>(Codes 315-316)<\/b><span>. Changes to existing authorizations, whether administrative or technical, have their respective codes. <\/span><span><br \/><\/span><span>Technical changes might include inspections or data reviews.<\/span><span><br \/><\/span><span>The authority additionally emphasizes that simultaneous submissions of the same technical variation for multiple authorizations benefit from reduced fees.<\/span><\/p>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_image et_pb_image_1\"> <span class=\"et_pb_image_wrap \"><img decoding=\"async\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2023\/11\/hpra-guidance-on-fees-authorization-regdesk-1.jpg\" alt=\"FDA Guidance on Distinguishing Medical Device Recalls from Enhancements: Key Concepts and Definitions\" title=\"HPRA on fees (authorization)2\"><\/span> <\/div>\n<div class=\"et_pb_module et_pb_text et_pb_text_4 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Wholesale_Distributor_Authorisations_WDA\"><\/span><b>Wholesale Distributor Authorisations (WDA)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span>Wholesale distributors face their own set of codes and associated fees.<br \/><\/span><\/p>\n<ul>\n<li><b>Code 290<\/b><span> \u2013 for those applying for a new WDA.<\/span><span><\/span><\/li>\n<li><span>Site Size and Scope (<\/span><b>Codes 286, 291-293<\/b><span>). WDAs vary based on the wholesaler\u2019s capacity and the range of products they supply. <\/span><span><br \/><\/span><span>This segmentation allows for a tailored fee structure, ranging from large full-line wholesalers to minor sites, which don\u2019t directly store products but operate on a \u201cProcure &amp; Supply\u201d basis.<\/span><span><\/span><\/li>\n<li><span>Variations to Authorisations (<\/span><b>Codes 294-296<\/b><span>). Similar to MIAs, WDAs can undergo administrative or technical changes. <\/span><span><br \/><\/span><span>Each type of change has its associated fee, with discounts available for certain conditions.<\/span><span><\/span><\/li>\n<li><b>Code 378<\/b><span>. This unique code is for wholesalers seeking classification for a product as a medicinal product.<\/span><\/li>\n<\/ul>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_5 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Active_Substance_Manufacturers_Distributors_and_Brokers\"><\/span><b>Active Substance Manufacturers, Distributors, and Brokers<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span>This category deals with those entities involved in the core components of medicinal products. The applicable codes are:<\/span><\/p>\n<ul>\n<li><b>Codes 376 &amp; 334<\/b><span>, are used for registering importers\/distributors and manufacturers of active substances, respectively. There is a provision for a single fee for specific combined registrations.<\/span><span><br \/>\n<\/span><\/li>\n<li><span>Changes to the Active Substances Register (<\/span><b>Codes 356 &amp; 359<\/b><span>). <\/span><span><br \/><\/span><span>Changes, whether administrative or those impacting quality\/safety, have distinct codes.<\/span><\/li>\n<\/ul>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_6 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Transfer_of_Ownership\"><\/span><b>Transfer of Ownership<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span>Ownership transfers, whether between related or unrelated entities, have their unique set of codes.<br \/><\/span><\/p>\n<ul>\n<li><span>&nbsp;<\/span><b>Codes 321-324<\/b><span>. These codes differentiate based on the relationship between the entities involved in the transfer. <\/span><span><br \/><\/span><span>They\u2019re also applicable to a variety of establishments and registrations.<\/span><\/li>\n<\/ul>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_7 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Inspections\"><\/span><b>Inspections<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span>A critical aspect of ensuring the quality and safety of medicinal products, inspections are a core function of the HPRA.<\/span><\/p>\n<ul>\n<li><b>Codes 371 &amp; 372<\/b><span>, which cover a vast array of inspection scenarios. This includes inspections related to applications, authorized entities, contract laboratories, and even third-country sites.<\/span><span><\/span><\/li>\n<li><span>Cancellation\/Reschedule fees (<\/span><b>Code 390<\/b><span>). Entities that reschedule or cancel inspections without adequate notice are subject to this fee.<\/span><\/li>\n<\/ul>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Certificates_and_Enforcement_Fees\"><\/span><b>Certificates and Enforcement Fees<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><b>Codes 351 &amp; 352<\/b><span>. Apply to various certificates, from exports to pharmaceutical products. There are also provisions for urgent supply and reissues.<br \/>\n<\/span><\/li>\n<li><span>Enforcement Fees (<b>Codes 303-308<\/b><span>). These annual fees cover the enforcement activities of the HPRA.<br \/><\/span><\/span>The fees vary based on the site\u2019s size, drawing parallels with the annual maintenance fees.<\/li>\n<\/ul>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_9 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Trials_Regulation\"><\/span><b>Clinical Trials Regulation<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><b>Code 265<\/b><span> for registering manufacturing processes of investigational medicinal products exempt from standard authorization. <\/span><span><br \/><\/span><span>This demonstrates the HPRA\u2019s flexibility and support for research.<\/span><\/li>\n<\/ul>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_10 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><b>Conclusion<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span>In summary, the HPRA\u2019s structured fee system provides a comprehensive framework for manufacturers, importers, and distributors in the pharmaceutical sector. <\/span><span><br \/><\/span><span>Each category and sub-category, with its specific codes and fees, ensures transparency and proper regulation.<\/span><\/p>\n<\/div><\/div>\n<p> <!-- .et_pb_text --><\/p>\n<div class=\"et_pb_module et_pb_text et_pb_text_11 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2><span class=\"ez-toc-section\" id=\"Source\"><\/span>Source<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.hpra.ie\/docs\/default-source\/publications-forms\/guidance-documents\/fin-g0002-guide-to-fees-for-human-products-v32.pdf?sfvrsn=91\">https:\/\/www.hpra.ie\/docs\/default-source\/publications-forms\/guidance-documents\/fin-g0002-guide-to-fees-for-human-products-v32.pdf?sfvrsn=91<\/a><\/p>\n<\/div><\/div>\n<p> <!-- .et_pb_text --> <\/div>\n<p> <!-- .et_pb_column --> <\/div>\n<p> <!-- .et_pb_row --><\/p>\n<div class=\"et_pb_row et_pb_row_3\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_12 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2 dir=\"ltr\"><span class=\"ez-toc-section\" id=\"How_Can_RegDesk_Help\"><\/span>How Can RegDesk Help?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p dir=\"ltr\"><strong>RegDesk<\/strong> is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.<\/p>\n<\/div><\/div>\n<p> <!-- .et_pb_text --> <\/div>\n<p> <!-- .et_pb_column --> <\/div>\n<p> <!-- .et_pb_row --> <\/div>\n<p> <!-- .et_pb_section --> <!-- .et_pb_section --> <\/div>\n<p><!-- .et_builder_inner_content --> <\/div>\n<p><!-- .et-l --> <\/div>\n<p><!-- #et-boc --> <\/p>\n<div class=\"blog-form\"> &lt;!&#8211; <\/p>\n<h5 class=\"blog-form-title\"> Want to know more about our solutions? Speak to a RegDesk Expert today! <\/h5>\n<p>&#8211;&gt; <\/p>\n<div id=\"form-in-blog\"> <\/div>\n<\/p><\/div>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. Empower Yourself. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platodata.network\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platoaistream\">PlatoAiStream. Web3 Intelligence. Knowledge Amplified. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoaistream.com\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platoesg\">PlatoESG. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/carbon\/\">Carbon,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/cleantech\/\">CleanTech,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/energy\/\">Energy,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/environment\/\">Environment,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/solar\/\">Solar,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/waste-management\/\">Waste Management.<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platohealth\">PlatoHealth. Biotech and Clinical Trials Intelligence. <a href=\"https:\/\/platohealth.ai\" target=\"_blank\" rel=\"noopener\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-source\"><span>Source:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.regdesk.co\/hpra-guidance-on-fees-authorization\/\">https:\/\/www.regdesk.co\/hpra-guidance-on-fees-authorization\/<\/a><\/li>\n<\/ul>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>The article addresses the aspects related to the fees payable in the context of authorization for medical device manufacturers, wholesalers, and distributors.&nbsp; Table of content The Health Products Regulatory Authority (HPRA), the Irish agency responsible for the regulation of healthcare products, has published a guidance document dedicated to fees payable in the context of registration [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":313278,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/313271"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=313271"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/313271\/revisions"}],"predecessor-version":[{"id":313277,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/313271\/revisions\/313277"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/313278"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=313271"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=313271"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=313271"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}