{"id":5971,"date":"2016-10-14T19:05:37","date_gmt":"2016-10-14T19:05:37","guid":{"rendered":"https:\/\/www.olartemoure.com\/web\/en\/?p=5971"},"modified":"2017-04-25T19:44:01","modified_gmt":"2017-04-25T19:44:01","slug":"om-weekly-digest-14-10-2016","status":"publish","type":"post","link":"https:\/\/olartemoure.com\/en\/om-weekly-digest-14-10-2016\/","title":{"rendered":"OM Weekly Digest (14-10-2016)"},"content":{"rendered":"<p><a href=\"http:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/03\/Cabezote2-eng-01.jpg\"><img decoding=\"async\" class=\"aligncenter wp-image-4119 size-full\" src=\"http:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/03\/Cabezote2-eng-01.jpg\" alt=\"Cabezote2 (eng)-01\" width=\"600\" height=\"124\" \/><\/a><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><strong><u>COLOMBIA\u00a0| Regulatory |\u00a0Colombian Regulatory Authority\u00a0publishes Immunogenicity Evaluation Guide for Biopharmaceuticals<\/u><\/strong><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">On 27 September 2016 -and by means of <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.minsalud.gov.co\/sites\/rid\/Lists\/BibliotecaDigital\/RIDE\/DE\/DIJ\/Resolucion-4490-de-2016.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Resolution 4490\/2016 (in Spanish)<\/a><\/span>-, the Ministry of Health and Social Protection issued the Immunogenicity Evaluation Guide for Biological Medicines.<\/p>\n<p style=\"text-align: justify;\">The Guide regulates <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.minsalud.gov.co\/Normatividad_Nuevo\/Decreto%201782%20de%202014.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Decree 1782\/2014 -in Spanish-<\/a><\/span> (which establishes requirements and procedures for pharmacological and pharmaceutical evaluations of biological medicines in marketing authorization\u00a0process) with regard to the guidelines to be met by manufacturers, applicants and titleholders of marketing authorizations to ensure the safety of biopharmaceuticals.<\/p>\n<p style=\"text-align: justify;\"><strong>The Guide will enter into force <span style=\"text-decoration: underline;\">one year after its issuance date<\/span>, and implies that the criteria established in Decree 1782\/2014 also starts to rule.<\/strong><\/p>\n<p style=\"text-align: justify;\">Immunogenicity determines how likely is a molecule to elicit an immune response in an organism. \u00a0According to the Resolution, its evaluation is mandatory because (i) its results could be unpredictable, (ii) it can be generated by any biological medicine and (iii) could have clinical consequences on its effectiveness or safety.<\/p>\n<p style=\"text-align: justify;\">The parameters of the Evaluation Guide can be found in the text of the Resolution.<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>URUGUAY\u00a0| Patents\u00a0| Uruguay\u00a0agrees to join the PCT in Free Trade Agreement signed with Chile<\/strong><\/span><\/h3>\n<p>On 4 October 2016, <span style=\"text-decoration: underline;\"><a href=\"https:\/\/translate.google.com\/translate?sl=es&amp;tl=en&amp;js=y&amp;prev=_t&amp;hl=es-419&amp;ie=UTF-8&amp;u=http%3A%2F%2Fwww.mrree.gub.uy%2Ffrontend%2Fpage%3F1%2Cinicio%2Campliacion-ppal2%2CO%2Ces%2C0%2CPAG%3BCONC%3B1961%3B39%3BD%3Bcancilleres-de-uruguay-y-chile-suscriben-tratado-de-libre-comercio%3B31%3BPAG%3B&amp;edit-text=\" target=\"_blank\" rel=\"noopener noreferrer\">the Presidents of Chile and Uruguay signed a Free Trade Agreement (FTA) between the two countries<\/a><\/span>, which in its intellectual property section establishes that Uruguay must adhere or ratify the <span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.wipo.int\/treaties\/en\/registration\/pct\/\" target=\"_blank\" rel=\"noopener noreferrer\">Patent Cooperation Treaty or PCT (1970)<\/a><\/span>.<\/p>\n<p>In previous years Uruguay has indicated that will adhere to the PCT, but this time is committed by means of a Treaty (FTA) to adopt that Agreement, once the FTA\u00a0is approved by the Congress of the subscribing countries and entries into force.<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">\u00a0<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>LATIN AMERICA | Trademarks\u00a0| INTA will open a Latin America and Caribbean Representative Office<\/strong><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.inta.org\/Pages\/Home.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">The International Trademark Association (INTA)<\/a><\/span> approved the creation of a Representative Office for Latin America and the Caribbean, according to the INTA&#8217;s objective of consolidate an international expansion, improving its presence in the region, increasing the participation of its members and strengthening its links with Trademark Offices and Associations of the region.<\/p>\n<p style=\"text-align: justify;\">The office will be located in Santiago de Chile and will be inaugurated in 2017 First Half.<\/p>\n<p style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.inta.org\/Press\/Pages\/LatAm_Office_Announcement.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">In the next link<\/a><\/span> you will find more information about the new office.<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>COLOMBIA\u00a0| Regulatory | Colombian Ministry of Health extends the deadline to obtain certification of Good Laboratory Practices in the Quality Control of Pharmaceuticals<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">By means of <span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/10\/161003-Resoluci%C3%B3n-4620-de-2016-Buenas-Practicas-de-Laboratorio.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Resolution 4620 of 3 October 2016<\/a><\/span>, the Ministry of Health and Social Protection gives a new deadline for laboratories that provides quality control services in pharmaceutical products to certify their good laboratory practices when developing these functions.<\/p>\n<p style=\"text-align: justify;\"><span style=\"text-decoration: underline;\">The new deadline to\u00a0obtain the\u00a0certification is <strong>18 months<\/strong><\/span> from the date of issue of Resolution 4620 of 2016.<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>. COLOMBIA\u00a0| Regulatory |\u00a0Colombian Regulatory Authority\u00a0publishes Immunogenicity Evaluation Guide for Biopharmaceuticals . On 27 September 2016 -and by means of Resolution 4490\/2016 (in Spanish)-, the Ministry of Health and Social Protection issued the Immunogenicity Evaluation Guide for Biological Medicines. The Guide regulates Decree 1782\/2014 -in Spanish- (which establishes requirements and procedures for pharmacological and pharmaceutical [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6260,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[59],"tags":[],"class_list":["post-5971","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-newsletter-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>OM Weekly Digest (14-10-2016) - OlarteMoure | Intellectual Property<\/title>\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\/om-weekly-digest-14-10-2016\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OM Weekly Digest (14-10-2016)\" \/>\n<meta property=\"og:description\" content=\". COLOMBIA\u00a0| Regulatory |\u00a0Colombian Regulatory Authority\u00a0publishes Immunogenicity Evaluation Guide for Biopharmaceuticals . On 27 September 2016 -and by means of Resolution 4490\/2016 (in Spanish)-, the Ministry of Health and Social Protection issued the Immunogenicity Evaluation Guide for Biological Medicines. 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