{"id":6001,"date":"2019-04-18T19:02:58","date_gmt":"2019-04-18T19:02:58","guid":{"rendered":"https:\/\/central-law.com\/modificacion-ley-medicamentos-salud-panama\/"},"modified":"2020-03-17T16:49:51","modified_gmt":"2020-03-17T16:49:51","slug":"modificacion-ley-medicamentos-salud-panama","status":"publish","type":"post","link":"https:\/\/central-law.com\/en\/modificacion-ley-medicamentos-salud-panama\/","title":{"rendered":"Modificaci\u00f3n Ley de medicamentos y otros productos para la salud en Panam\u00e1"},"content":{"rendered":"<p>La presente tiene por objeto informarles que el d\u00eda viernes 15 de febrero de 2019, se public\u00f3 en Gaceta Oficial el Decreto Ejecutivo 40 de 13 de febrero de 2019:<strong>\u00a0<\/strong><\/p>\n<ul>\n<li>Aumento CONSIDERABLE en tasas de servicio que brinda F y D. Entre los m\u00e1s relevantes podemos mencionar:<\/li>\n<\/ul>\n<table>\n<tbody>\n<tr>\n<td width=\"415\"><strong>Servicio<\/strong><\/td>\n<td width=\"173\"><strong>Tasa Nueva<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de registro para farmac\u00e9uticos de s\u00edntesis qu\u00edmica<\/td>\n<td width=\"173\">US$500.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de registro para farmac\u00e9uticos innovadores, biol\u00f3gicos y biotecnol\u00f3gicos<\/td>\n<td width=\"173\">US$750.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de registro tr\u00e1mite abreviado<\/td>\n<td width=\"173\">US$750.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de registro para desinfectantes de uso hospitalario y productos de higiene personal<\/td>\n<td width=\"173\">US$500.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de registro para cosm\u00e9ticos hasta 10 variedades<\/td>\n<td width=\"173\">US$500.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de registro para cosm\u00e9ticos por cada 10 variedades adicionales<\/td>\n<td width=\"173\">US$200.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de registro para plaguicidas de salud publica<\/td>\n<td width=\"173\">US$500.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Renovaci\u00f3n de registro para farmac\u00e9uticos de s\u00edntesis qu\u00edmica<\/td>\n<td width=\"173\">US$500.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Renovaci\u00f3n de registro para farmac\u00e9uticos innovadores, biol\u00f3gicos y biotecnol\u00f3gicos<\/td>\n<td width=\"173\">US$750.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Renovaci\u00f3n de registro para cosm\u00e9ticos y similares y productos sanitarios de higiene personal<\/td>\n<td width=\"173\">US$500.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Renovaci\u00f3n de registro para plaguicidas de salud publica<\/td>\n<td width=\"173\">US$500.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Tasa por servicio de modificaci\u00f3n<\/td>\n<td width=\"173\">US$200.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Autenticaci\u00f3n de documentos<\/td>\n<td width=\"173\">US$30.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Reimpresi\u00f3n del Certificado de Registro, Intercambiabilidad o Licencia de Operaci\u00f3n<\/td>\n<td width=\"173\">US$200.00<\/td>\n<\/tr>\n<tr>\n<td width=\"415\">Expedici\u00f3n de Certificaciones en general<\/td>\n<td width=\"173\">US$200.00<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<ul>\n<li>Se incluye 1 requisito adicional para tr\u00e1mites de Registro Sanitario de medicamento y cosm\u00e9tico: Declaraci\u00f3n Jurada que acredite que el medicamento a registrar y comercializar es el mismo en cuanto a fabricaci\u00f3n y formulaci\u00f3n que el declarado en el CLV o CPP.<\/li>\n<li>Se acort\u00f3 el plazo concedido para que se subsanen errores u omisiones a 2 MESES contados a partir de la comunicaci\u00f3n, y de no subsanarse, se declarar\u00e1 el abandono.<\/li>\n<li>Importante mencionar que las actuaciones y aportaci\u00f3n de documentos que no cumpla con las observaciones, NO INTERRUMPLE el t\u00e9rmino para declarar el abandono.<\/li>\n<li>Para procedimientos abreviados tambi\u00e9n se acort\u00f3 el tiempo para subsanar observaciones a 2 MESES contados a partir de la comunicaci\u00f3n, y de no subsanarse, se declarar\u00e1 el abandono.<\/li>\n<li>No se aceptar\u00e1n modificaciones y notificaciones 6 meses antes del vencimiento del registro sanitario, y deber\u00e1n tramitarse junto con la renovaci\u00f3n.<\/li>\n<li>Para los casos de RENOVACIONES DE MEDICAMENTOS, el plazo para subsanar observaciones se acort\u00f3 a 30 DIAS HABILES.<\/li>\n<li>Para los casos COSMETICOS, el plazo para subsanar observaciones se acort\u00f3 a 30 DIAS HABILES.<\/li>\n<li>Para el tr\u00e1mite de registro de cosm\u00e9ticos se aceptar\u00e1 la presentaci\u00f3n de muestra o foto del producto a color y legible.<\/li>\n<li>Se aceptan las siguientes modificaciones para cosm\u00e9ticos:<\/li>\n<\/ul>\n<ol>\n<li>Cambio en empaque o presentaciones<\/li>\n<li>Cambio de formulaci\u00f3n<\/li>\n<li>Cambio del nombre del producto<\/li>\n<li>Cambio del fabricante<\/li>\n<li>Cambio del titular<\/li>\n<li>Cambio de raz\u00f3n social del fabricante o titular<\/li>\n<\/ol>\n<ul>\n<li>No ser\u00e1 necesario la presentaci\u00f3n de copias autenticadas por FyD para actos p\u00fablicos.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong><u>El presente Decreto comenz\u00f3 a regir a partir del d\u00eda siguiente de su promulgaci\u00f3n, es decir, el Lunes 18 de febrero de 2019.<\/u><\/strong><\/p>\n<p>Yolianna Arosemena<br \/>\nAsociada<br \/>\nCENTRAL LAW<br \/>\nPanam\u00e1<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La presente tiene por objeto informarles que el d\u00eda viernes 15 de febrero de 2019, se public\u00f3 en Gaceta Oficial el Decreto Ejecutivo 40 de 13 de febrero de 2019:\u00a0 Aumento CONSIDERABLE en tasas de servicio que brinda F y D. Entre los m\u00e1s relevantes podemos mencionar: Servicio Tasa Nueva Expedici\u00f3n de registro para farmac\u00e9uticos [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":12168,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"","ofc_meta_disable_footer_callout":"","ofc_meta_callout_button_url":"","ofc_meta_callout_button_txt":"","ofc_meta_callout_text":"","ofc_enable_fullscreen":"disable","ofc_fullscreen_speed":0,"ofc_fullscreen_nav":"enable","ofc_fullscreen_nav_pos":"right","ofc_fullscreen_nav_color":"","ofc_fullscreen_nav_tooltip_color":"","ofc_fullscreen_responsive":0,"osh_disable_topbar_sticky":"default","osh_disable_header_sticky":"default","osh_sticky_header_style":"default","osh_sticky_header_effect":"","osh_custom_sticky_logo":0,"osh_custom_retina_sticky_logo":0,"osh_custom_sticky_logo_height":0,"osh_background_color":"","osh_links_color":"","osh_links_hover_color":"","osh_links_active_color":"","osh_links_bg_color":"","osh_links_hover_bg_color":"","osh_links_active_bg_color":"","osh_menu_social_links_color":"","osh_menu_social_hover_links_color":"","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"off","ocean_gallery_id":[],"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6001","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categoria","entry","has-media"],"_links":{"self":[{"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2\/posts\/6001","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2\/comments?post=6001"}],"version-history":[{"count":1,"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2\/posts\/6001\/revisions"}],"predecessor-version":[{"id":60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