{"id":15579,"date":"2025-01-28T19:51:55","date_gmt":"2025-01-28T19:51:55","guid":{"rendered":"https:\/\/central-law.com\/?p=15579"},"modified":"2025-02-11T07:46:31","modified_gmt":"2025-02-11T07:46:31","slug":"executive-decree-no-2-of-2025-simplification-of-sanitary-registration-in-panama","status":"publish","type":"post","link":"https:\/\/central-law.com\/en\/executive-decree-no-2-of-2025-simplification-of-sanitary-registration-in-panama\/","title":{"rendered":"PANAMA – Executive Decree No. 2 of 2025: Simplification of Sanitary Registration"},"content":{"rendered":"

Summary of Executive Decree No. 2 of January 7, 2025<\/b><\/p>\n

Executive Decree No. 2 of January 7, 2025<\/b>, issued by the Ministry of Health of Panama, establishes a procedure for the <\/span>automatic recognition of sanitary registrations<\/b> for medicines <\/span>manufactured and registered<\/b> in countries whose regulatory authorities are part of the list of authorities recognized by the World Health Organization (WLA).<\/span><\/p>\n

The regulation simplifies the sanitary registration process for medicines approved by authorities with high regulatory standards, eliminating the need for prior laboratory analysis, provided that the established conditions are met.<\/span><\/p>\n

Requirements to Apply for the Automatic Recognition Procedure (Article 2)<\/b><\/p>\n

    \n
  1. Proof of payment<\/b> for the fee corresponding to the issuance of the sanitary registration through the expedited process.<\/span><\/li>\n
  2. Completed form<\/b> as established by the National Directorate of Pharmacy and Drugs, submitted through the digital platform FADDI, with the endorsement of the responsible pharmacist and the National College of Pharmacists.<\/span><\/li>\n
  3. Legalized power of attorney<\/b> accrediting the legal or technical representation of the holder of the pharmaceutical product by a natural or legal person residing in Panama.<\/span><\/li>\n
  4. Original Pharmaceutical Product Certificate<\/b>, legalized or apostilled, issued by the country of origin. If multiple laboratories are involved, information on compliance with Good Manufacturing Practices must be included.<\/span><\/li>\n
  5. Legalized or apostilled copy of the complete dossier<\/b>submitted in the country of origin to ensure post-recognition health surveillance.<\/span><\/li>\n
  6. Stability studies<\/b> for medicines requiring it, according to the climatic zone IVb applicable to Panama.<\/span><\/li>\n
  7. Consistency of information<\/b> between the country of origin of the medicine and the certificate submitted via the FADDI platform.<\/span><\/li>\n<\/ol>\n

    \u00a0<\/span>The process, conducted exclusively through the FADDI platform, must be completed within a maximum of <\/span>ten business days<\/b>, unless technical observations are identified. In case corrections are needed, the applicant has an additional <\/span>five business days<\/b> to address the inconsistencies. Otherwise, the request will be canceled.<\/span><\/p>\n

    \u00a0<\/span>This decree aims to streamline access to safe and effective medicines for the Panamanian population, while maintaining high-quality standards through post-recognition health surveillance.<\/span><\/p>\n

    \u00a0<\/span>The regulation came into effect on the date of its promulgation and is based on existing legal provisions, such as Law 419 of 2024 and Law 109 of 2019.<\/span><\/p>\n

    \u00a0<\/span>For more information, contact us to assess the impact of this regulation on your business activities and market strategies: <\/span>info@central-law.com<\/p>\n

    Yolianna Arosemena Benedetti<\/b><\/strong><\/a>
    \nPartner<\/strong>
    \nPanama<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

    Summary of Executive Decree No. 2 of January 7, 2025 Executive Decree No. 2 of January 7, 2025, issued by the Ministry of Health of Panama, establishes a procedure for the automatic recognition of sanitary registrations for medicines manufactured and registered in countries whose regulatory authorities are part of the list of authorities recognized by […]<\/p>\n","protected":false},"author":3,"featured_media":15583,"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":"0","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":"0","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":"on","ocean_gallery_id":[],"footnotes":""},"categories":[44],"tags":[1100,1101,1102,1103,1104,1105,1106,1107,1108,1109],"class_list":["post-15579","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-panama-2","tag-sanitary-registration-panama-2025","tag-executive-decree-no-2-of-2025","tag-automatic-recognition-of-medicines","tag-simplification-of-sanitary-registrations-in-panama","tag-faddi-procedure-panama","tag-requirements-for-sanitary-registration-in-panama","tag-medicines-approved-by-who","tag-post-market-surveillance-in-panama","tag-law-419-of-2024-panama","tag-pharmaceutical-regulation-panama","entry","has-media"],"_links":{"self":[{"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2\/posts\/15579","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/central-law.com\/en\/wp-json\/wp\/v2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