{"id":22425,"date":"2025-12-25T11:45:04","date_gmt":"2025-12-25T10:45:04","guid":{"rendered":"https:\/\/www.miph.gov.dz\/fr\/?page_id=22425"},"modified":"2026-04-12T11:01:14","modified_gmt":"2026-04-12T10:01:14","slug":"lignes-directrices","status":"publish","type":"page","link":"https:\/\/www.miph.gov.dz\/fr\/lignes-directrices\/","title":{"rendered":"Guides &#038; Lignes directrices &#8212; Guides &#038; Guidelines"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"22425\" class=\"elementor elementor-22425\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7839642 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7839642\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d5d6383\" data-id=\"d5d6383\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-397d488 elementor-widget__width-initial elementor-widget elementor-widget-accordion\" data-id=\"397d488\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6021\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-6021\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-angle-double-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-angle-double-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Lignes Directrices<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6021\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-6021\"><p><strong>05\/02\/2026<\/strong><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/ligne-directrice-recours-et-plaintes-.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice relative aux plaintes et recours contre les d\u00e9cisions r\u00e9glementaires<\/strong><\/a><\/p><p><strong>05\/02\/2026<\/strong><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/FORMAT-ET-LE-CONTENU-DES-DEMANDES-DAUTORISATION-DIMPORTATION.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice sp\u00e9cifiant les conditions, le format et le contenu des demandes d\u2019autorisation d\u2019importation<\/strong><\/a><\/p><p><strong>05\/02\/2026<\/strong><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/NOMENCLATURE.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice relative <\/strong><strong>\u00e0 la mise \u00e0 jour de la nomenclature des produits pharmaceutiques et a sa publication<\/strong><\/a><\/p><p><strong>05\/02\/2026<\/strong><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/OBTENTION-DAGREMENT.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice relative \u00e0 l&rsquo;obtention de l&rsquo;agr\u00e9ment d&rsquo;un \u00e9tablissement pharmaceutique d&rsquo;importation, de distribution en gros et d&rsquo;exploitation<\/strong><\/a> <strong>(version 02)<\/strong><\/p><p><span style=\"color: #727272; font-weight: 600;\">05\/02\/2026<\/span><\/p><p><strong><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/LD-reclamations.pdf\" target=\"_blank\" rel=\"noopener\">\u00a0Ligne directrice relative \u00e0 la gestion des r\u00e9clamations\u00a0<\/a><\/strong><strong>(Version N\u00b01)<\/strong><\/p><p><span style=\"color: #727272; font-weight: 600;\">04\/02\/2026<\/span><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/finale-Ligne-Directrice-relative-a-lexportation-version-1.4-du-04.02.2026.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice Relative \u00e0 La D\u00e9livrance D\u2019autorisation D\u2019exportation Des Produits Pharmaceutiques et\/ou Des Dispositifs M\u00e9dicaux<\/strong><\/a><\/p><p><span style=\"color: #727272; font-weight: 600;\">04\/02\/2026<\/span><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/LD-redaction-du-dossier-maitre-du-site-de-fabrication.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice Relative \u00e0 la r\u00e9daction du dossier ma\u00eetre du site (\u00e9tat des lieux des \u00e9tablissements pharmaceutiques de fabrication)<span style=\"color: #727272;\">\u00a0<\/span><\/strong><\/a><\/p><p><span style=\"font-weight: 600; color: #727272;\">04\/02\/2026<\/span><\/p><p><strong><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/LD-depot-et-de-traitement-des-modifications-liees-aux-etablissements-pharmaceutiques-de-fabrication.pdf\" target=\"_blank\" rel=\"noopener\">Ligne directrice Relative aux modalit\u00e9s de d\u00e9p\u00f4t et de traitement des modifications li\u00e9es aux \u00e9tablissements pharmaceutiques de fabrication<\/a><\/strong>\u00a0<\/p><p><strong>02\/02\/2026<\/strong><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/LD-obtention-dagrement-de-fabrication.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice Relative \u00e0 l\u2019obtention d&rsquo;un agr\u00e9ment d&rsquo;un \u00e9tablissement pharmaceutique de fabrication<\/strong><\/a><strong> (Version N\u00b01)<\/strong><\/p><p><strong>22\/01\/2026<\/strong><\/p><p><strong><a href=\"https:\/\/miph.gov.dz\/wp-content\/uploads\/2026\/01\/LD-COMMUNICATION-DE-LINFORMATION-EN-INTERNE-ET-EN-EXTERNE-1.pdf\" target=\"_blank\" rel=\"noopener\">LIGNE DIRECTRICE POUR LA COMMUNICATION DE L&rsquo;INFORMATION EN INTERNE ET EN EXTERNE<\/a><\/strong><\/p><p><strong>22\/01\/2026<\/strong><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/01\/2026-01-21-1.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice pour l&rsquo;\u00e9laboration des textes l\u00e9gislatifs et r\u00e9glementaires<\/strong><\/a><\/p><p><strong>11\/01\/2026<\/strong><\/p><p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/01\/LD-autorisation-dimportation.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice sp\u00e9cifiant les conditions, le format et le contenu des demandes d&rsquo;autorisation d&rsquo;importation<\/strong><\/a><\/p><p><strong>08\/01\/2026<\/strong><\/p><p><a href=\"https:\/\/miph.gov.dz\/wp-content\/uploads\/2026\/01\/ligne-directrice-agrement.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Ligne directrice relative \u00e0 l&rsquo;obtention de l&rsquo;agr\u00e9ment d&rsquo;un \u00e9tablissement pharmaceutique d&rsquo;importation, de distribution en gros et d&rsquo;exploitation<\/strong><\/a><\/p><p><strong>28\/12\/2025 \u00a0<\/strong><\/p><ul><li><strong><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/LIGNE-DIRECTRICE-POUR-LA-CONDUITE-DES-ETUDES-CLINIAQUES-EN-ALGERIE-V2-O.pdf\" target=\"_blank\" rel=\"noopener\" data-wplink-edit=\"true\">Ligne directrice relative \u00e0 la conduite des \u00e9tudes cliniques en Alg\u00e9rie<\/a>\u00a0<\/strong>(version 2)<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6022\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-6022\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-angle-double-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-angle-double-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Guides<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6022\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-6022\"><p><strong>01\/03\/2026&nbsp;<\/strong><\/p>\n<h4><strong><a href=\"https:\/\/miph.gov.dz\/wp-content\/uploads\/2026\/03\/GUIDE-BPC-DZ-DRAFT.pdf\">Guide des bonnes pratiques cliniques applicable sur les \u00e9tudes cliniques en Alg\u00e9rie&nbsp;<\/a><\/strong><\/h4>\n<p><strong>11\/02\/2026&nbsp;<\/strong><\/p>\n<p><strong><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/02\/guide-des-bpd-et-bps.docx-V2.pdf\" target=\"_blank\" rel=\"noopener\">GUIDE DES BONNES PRATIQUES DE DISTRIBUTION ET DE STOCKAGE DES PRODUITS DE SANTE A USAGE HUMAIN<\/a>( version 2)<\/strong><\/p>\n<p><b>08\/04\/2026<\/b><\/p>\n<p style=\"text-align: justify;\"><b><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2026\/04\/guide-importation-finale.pdf\" target=\"_blank\" rel=\"noopener\" style=\"background-color: rgb(255, 255, 255); transition-property: all; text-align: left;\">Guide sur l\u2019application des dispositions d\u2019apposition du code-barres bidimensionnel(2D) Data Matrix Sur les produits pharmaceutiques import\u00e9s<\/a><span style=\"color: rgb(114, 114, 114); text-align: left;\">&nbsp;(Version 1.0)<\/span><\/b><\/p>\n<p><b>25\/12\/2025<\/b><\/p>\n<ul>\n<li style=\"text-align: justify;\"><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2025\/12\/guide-des-bpd-et-bps.pdf\" target=\"_blank\" rel=\"noopener\"><strong>GUIDE DES BONNES PRATIQUES DE DISTRIBUTION ET DE STOCKAGE DES PRODUITS DE SANTE A USAGE HUMAIN <\/strong><\/a><strong>( l&rsquo;ensemble des partie concern\u00e9es sont invit\u00e9es \u00e0 consulter ce guide et \u00e0 transmettre leurs observations et commentaires \u00e0 l&rsquo;adresse \u00e9lectronique suivante : regulation@miph.gov.dz)<\/strong><\/li>\n<\/ul>\n<p><strong>03\/06\/2022<\/strong><\/p>\n<p><a href=\"https:\/\/www.miph.gov.dz\/fr\/wp-content\/uploads\/2022\/09\/Guide-des-BPF2022.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Guide des bonnes pratiques de fabrication <\/strong><\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3050c37 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3050c37\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-63e8454\" data-id=\"63e8454\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-429f833 elementor-widget elementor-widget-html\" data-id=\"429f833\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<script> \r\n\tjQuery(document).ready(function($) { \r\n\tvar delay = 100; setTimeout(function() { \r\n\t$('.elementor-tab-title').removeClass('elementor-active');\r\n\t$('.elementor-tab-content').css('display', 'none'); }, delay); \r\n\t}); \r\n<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Lignes Directrices 05\/02\/2026 Ligne directrice relative aux plaintes et recours contre les d\u00e9cisions r\u00e9glementaires 05\/02\/2026 Ligne directrice sp\u00e9cifiant les conditions, le format et le contenu des demandes d\u2019autorisation d\u2019importation 05\/02\/2026 Ligne directrice relative \u00e0 la mise \u00e0 jour de la nomenclature des produits pharmaceutiques et a sa publication 05\/02\/2026 Ligne directrice relative \u00e0 l&rsquo;obtention de [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-22425","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/pages\/22425","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/comments?post=22425"}],"version-history":[{"count":140,"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/pages\/22425\/revisions"}],"predecessor-version":[{"id":24258,"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/pages\/22425\/revisions\/24258"}],"wp:attachment":[{"href":"https:\/\/www.miph.gov.dz\/fr\/wp-json\/wp\/v2\/media?parent=22425"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}