{"id":4399959,"date":"2023-10-30T15:56:33","date_gmt":"2023-10-30T20:56:33","guid":{"rendered":"https:\/\/www.olartemoure.com\/?p=4399959"},"modified":"2024-06-20T08:38:06","modified_gmt":"2024-06-20T13:38:06","slug":"pharma-and-medical-device-regulation-gtdt-lexology","status":"publish","type":"post","link":"https:\/\/olartemoure.com\/en\/pharma-and-medical-device-regulation-gtdt-lexology\/","title":{"rendered":"Pharma and medical device regulation &#8211; Lexology 2023"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;section&#8221; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_row admin_label=&#8221;row&#8221; _builder_version=&#8221;4.22.2&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; width=&#8221;100%&#8221; sticky_enabled=&#8221;0&#8243;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text admin_label=&#8221;Text&#8221; _builder_version=&#8221;4.22.2&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; text_font=&#8221;|700|||||||&#8221; text_text_color=&#8221;#003366&#8243; text_font_size=&#8221;1.3em&#8221; text_line_height=&#8221;1.5em&#8221; sticky_enabled=&#8221;0&#8243;]A Clear Guide for the Regulation of the Pharma and Medical Device Industry in Colombia[\/et_pb_text][et_pb_text _builder_version=&#8221;4.22.2&#8243; _module_preset=&#8221;default&#8221; theme_builder_area=&#8221;post_content&#8221; text_font_size=&#8221;1.2em&#8221; text_line_height=&#8221;1.5em&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]The Pharma and Medical Device industry is one of the biggest in the world. Its regulation changes country to country, which can sometimes make comparisons difficult. Due to this, Lexology decided to publish a series of reference guides that allow for comparison among more than 20 jurisdictions all around the world. Each of these explains in depth the regulation of the Pharma and Medical Device industry in said jurisdiction.<\/p>\n<p>One of the chosen jurisdictions was Colombia. At OlarteMoure we drafted this guide, in which we explain in depth the regulation of the Pharma and Medical Device industry in this country. We touch on topics like its regulatory framework, clinical practice, marketing authorization, amending authorizations, recall, promotion, enforcement of advertising rules, pricing and reimbursement, off-label use and unlicensed products, sale and supply, and recent trends that have been noticed.<\/p>\n<p>In this guide, you will learn more about plenty of topics, like the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices in Colombia, the sanctions that authorities can impose on entities or their directors and officers for breach of the requirements concerning controlled activities, and the requirements that apply to recording and publishing details of transfers of value to healthcare professionals and organizations by companies marketing medicinal products or medical devices in the country.<\/p>\n<p>This detailed and enriching document was carefully crafted by Carlos R. Olarte, our Partner, Gina Arias, our Regulatory Affairs Manager, Catalina Jim\u00e9nez, our Partner and Compliance Director, and Liliana Galindo, our Patent Litigation Coordinator. This team of experts provided their lengthy knowledge of this industry to provide clear and in-depth information for each of the categories requested.<\/p>\n<p>We hope this type of resource is useful for understanding the regulation of this important industry, that is present in our day to day live, and is constantly evolving and innovating.[\/et_pb_text][dsm_button _builder_version=&#8221;4.22.2&#8243; _module_preset=&#8221;default&#8221; theme_builder_area=&#8221;post_content&#8221; button_one_text=&#8221;Download it here!&#8221; button_one_url=&#8221;https:\/\/www.olartemoure.com\/wp-content\/uploads\/2023\/10\/2024-Pharma-Medical-Device-Regulation-Colombia.pdf&#8221; button_one_url_new_window=&#8221;on&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;][\/dsm_button][et_pb_text _builder_version=&#8221;4.22.2&#8243; _module_preset=&#8221;default&#8221; theme_builder_area=&#8221;post_content&#8221; text_font_size=&#8221;1.2em&#8221; text_line_height=&#8221;1.5em&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]If you need more details or help with any specific case contact us.[\/et_pb_text][dsm_contact_form_7 _builder_version=&#8221;4.22.2&#8243; _module_preset=&#8221;default&#8221; theme_builder_area=&#8221;post_content&#8221; cf7_library=&#8221;6543&#8243; show_validation=&#8221;on&#8221; border_color_all_image=&#8221;#FFFFFF&#8221; border_width_all_image=&#8221;0.3em&#8221; width=&#8221;70%&#8221; width_last_edited=&#8221;on|phone&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243; width_tablet=&#8221;70%&#8221; module_alignment_last_edited=&#8221;on|tablet&#8221; module_alignment_tablet=&#8221;center&#8221; width_phone=&#8221;100%&#8221; module_alignment_phone=&#8221;center&#8221;][\/dsm_contact_form_7][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Getting the Deal through and Lexology bring us the new edition of the Pharma and medical device regulation edition.<\/p>\n","protected":false},"author":5,"featured_media":4399960,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<!-- wp:divi\/placeholder \/-->","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[109,1092],"tags":[],"class_list":["post-4399959","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-affairs","category-contributions"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pharma and medical device regulation - OlarteMoure<\/title>\n<meta name=\"description\" content=\"Getting the Deal through and Lexology bring us the new edition of the Pharma and medical device regulation edition.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/olartemoure.com\/en\/pharma-and-medical-device-regulation-gtdt-lexology\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma and medical device regulation - Lexology 2023\" \/>\n<meta property=\"og:description\" content=\"Getting the Deal through and Lexology bring us the new edition of the Pharma and medical device regulation edition.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/olartemoure.com\/en\/pharma-and-medical-device-regulation-gtdt-lexology\/\" \/>\n<meta property=\"og:site_name\" content=\"OlarteMoure | Intellectual Property\" \/>\n<meta property=\"article:published_time\" content=\"2023-10-30T20:56:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-06-20T13:38:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/olartemoure.com\/wp-content\/uploads\/2023\/10\/GTDT-Pharma-Medical-Device-Regulation.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"836\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Nicole Diaz\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Nicole Diaz\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/pharma-and-medical-device-regulation-gtdt-lexology\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/pharma-and-medical-device-regulation-gtdt-lexology\\\/\"},\"author\":{\"name\":\"Nicole Diaz\",\"@id\":\"https:\\\/\\\/olartemoure.com\\\/#\\\/schema\\\/person\\\/39418ad779f2cd1c62156f11faaf2e31\"},\"headline\":\"Pharma and medical device regulation &#8211; 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