{"id":51079,"date":"2020-07-14T19:49:00","date_gmt":"2020-07-14T23:49:00","guid":{"rendered":"https:\/\/live.livingstonintl.com\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/"},"modified":"2020-07-25T19:52:19","modified_gmt":"2020-07-25T23:52:19","slug":"health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar","status":"publish","type":"post","link":"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/","title":{"rendered":"Modifications au R\u00e8glement sur les aliments et drogues de Sant\u00e9\u00a0Canada et webinaire \u00e0 venir"},"content":{"rendered":"<p>Sant\u00e9&nbsp;Canada a annonc\u00e9 que des modifications au <em>R\u00e8glement sur les aliments et drogues <\/em>entreront en vigueur le 1<sup>er<\/sup>&nbsp;juillet 2020 dans le cadre de <a href=\"https:\/\/laws.justice.gc.ca\/fra\/LoisAnnuelles\/2020_1\/TexteComplet.html\" target=\"_blank\" rel=\"noopener noreferrer\">l\u2019Accord&nbsp;Canada-\u00c9tats-Unis-Mexique (ACEUM).<\/a><\/p>\n<p>Les modifications refl\u00e8tent plusieurs des flexibilit\u00e9s, y compris l\u2019\u00e9limination des exigences de duplication des tests et la permission pour l\u2019exp\u00e9dition directe de certains m\u00e9dicaments en vente libre. Dans le cadre de l\u2019entr\u00e9e en vigueur, les modifications r\u00e9glementaires comprennent \u00e9galement des permissions pour la distribution de certains m\u00e9dicaments en vente libre comme \u00e9chantillons.<\/p>\n<p>Les modifications r\u00e9glementaires offrent une flexibilit\u00e9 aux importateurs de produits \u00e0 faible risque et Sant\u00e9 Canada travaille activement \u00e0 augmenter le nombre de produits auxquels les modifications r\u00e9glementaires s\u2019appliquent. Bien que les travaux visant \u00e0 \u00e9largir la port\u00e9e des r\u00e8glements soient en cours, Sant\u00e9 Canada \u00e9largira les mesures int\u00e9rimaires afin de s\u2019assurer qu\u2019une gamme plus large de produits puisse pr\u00e9valoir de ces flexibilit\u00e9s, y compris celles identifi\u00e9es dans l\u2019annexe ci-dessous.<\/p>\n<p>Les modifications visant \u00e0 \u00e9liminer les exigences de duplication de tests et \u00e0 permettre l\u2019exp\u00e9dition directe sont \u00e9tendues par le pr\u00e9sent r\u00e8glement pour s\u2019appliquer \u00e0 tous les produits \u00e9num\u00e9r\u00e9s \u00e0 l\u2019annexe&nbsp;A provenant de <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/conformite-application-loi\/legislation-modifications-reglementaires\/incorporation-par-renvoi\/liste-pays-etrangers.html\" target=\"_blank\" rel=\"noopener noreferrer\">pays ou r\u00e9gions reconnus<\/a>. Cette mesure provisoire sera en place jusqu\u2019\u00e0 ce que la <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/conformite-application-loi\/legislation-modifications-reglementaires\/incorporation-par-renvoi\/liste-drogues-vendues-sans-ordonnance.html\" target=\"_blank\" rel=\"noopener noreferrer\">liste<\/a> officielle mentionn\u00e9e dans les modifications au r\u00e8glement ait \u00e9t\u00e9 officiellement mise \u00e0 jour.<\/p>\n<p>Sant\u00e9&nbsp;Canada \u00e9largira \u00e9galement la liste des m\u00e9dicaments qui peuvent \u00eatre distribu\u00e9s comme \u00e9chantillons. Bien que nous travaillions \u00e0 la mise en \u0153uvre de la liste \u00e9largie, les produits \u00e0 l\u2019annexe&nbsp;A seront exempt\u00e9s des interdictions d\u2019\u00e9chantillonnage \u00e0 la lumi\u00e8re des changements imminents et des mesures d\u2019application seront d\u00e9cr\u00e9t\u00e9es. Cette mesure provisoire sera en place jusqu\u2019\u00e0 ce que la <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/produits-autosoins-reglementation-medicaments-sans-ordonnace\/liste-d-drogues-vendues-ordonnance-distribuees-echantillions.html\" target=\"_blank\" rel=\"noopener noreferrer\">liste<\/a> mentionn\u00e9e dans les modifications au r\u00e8glement ait \u00e9t\u00e9 officiellement mise \u00e0 jour.<\/p>\n<p><strong><em>Que signifie l\u2019\u00e9limination des exigences de duplication des tests?<\/em><\/strong><\/p>\n<p>Les importateurs des produits \u00e9num\u00e9r\u00e9s \u00e0 l\u2019annexe&nbsp;A des <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/conformite-application-loi\/legislation-modifications-reglementaires\/incorporation-par-renvoi\/liste-pays-etrangers.html\" target=\"_blank\" rel=\"noopener noreferrer\">pays ou r\u00e9gions reconnus<\/a> n\u2019ont pas \u00e0 effectuer&nbsp;:<\/p>\n<ul>\n<li>des tests d\u2019identit\u00e9 apr\u00e8s r\u00e9ception au Canada dans le cadre du processus de lib\u00e9ration; et<\/li>\n<li>des essais de confirmation.<\/li>\n<\/ul>\n<p>Les importateurs des produits concern\u00e9s doivent s\u2019assurer que les produits sont fabriqu\u00e9s de mani\u00e8re appropri\u00e9e et qu\u2019ils r\u00e9pondent aux sp\u00e9cifications du produit fini. Les modifications au r\u00e8glement permettent d\u2019effectuer de telles d\u00e9terminations au moyen d\u2019un certificat de lot ou d\u2019un certificat d\u2019examen de fabrication\/d\u2019analyse.<\/p>\n<p><strong><em>Qu\u2019est-ce que l\u2019exp\u00e9dition directe? <\/em><\/strong><\/p>\n<p>L\u2019exp\u00e9dition directe signifie que les importateurs pourront exp\u00e9dier des produits d\u2019un site \u00e9tranger directement \u00e0 un client canadien (p. ex. un d\u00e9taillant\/grossiste). L\u2019exp\u00e9dition directe sera autoris\u00e9e dans les conditions suivantes&nbsp;:<\/p>\n<ol>\n<li>L\u2019importateur distribue le m\u00e9dicament avant qu\u2019il soit exp\u00e9di\u00e9 en examinant tous les documents et les r\u00e9sultats des tests applicables;<\/li>\n<li>L\u2019importateur a mis en place des mesures pour veiller au respect des exigences du r\u00e8glement. Ceci implique la d\u00e9finition des r\u00f4les et des responsabilit\u00e9s et l\u2019obtention des ententes appropri\u00e9es entre toutes les parties, y compris le fabricant \u00e9tranger, l\u2019importateur et la personne recevant le produit (p. ex. le d\u00e9taillant ou le grossiste).<\/li>\n<\/ol>\n<p><strong><em>Y aura-t-il des directives concernant l\u2019\u00e9limination des exigences de duplication des tests et la permission d\u2019exp\u00e9dition directe? <\/em><\/strong><\/p>\n<p>Les documents d\u2019orientation suivants seront mis \u00e0 jour au cours des prochaines semaines en r\u00e9ponse aux modifications au r\u00e8glement&nbsp;:<\/p>\n<ol>\n<li><em>Guide des Bonnes pratiques de fabrication pour les produits pharmaceutiques <\/em>(<em>GUI-0001<\/em>)<\/li>\n<li><em>Annexe&nbsp;7 du guide des Bonnes pratiques de fabrication pour les produits pharmaceutiques- Certains m\u00e9dicaments en vente libre <\/em>(<em>GUI-0066<\/em>).<\/li>\n<\/ol>\n<p>Remarque&nbsp;: GUI-0066 s\u2019appliquera \u00e0 tous les produits \u00e9num\u00e9r\u00e9s \u00e0 l\u2019annexe&nbsp;A et le titre du document d\u2019orientation a \u00e9t\u00e9 modifi\u00e9 pour refl\u00e9ter sa port\u00e9e \u00e9largie.<\/p>\n<p>Les deux documents d\u2019orientation comprendront des mises \u00e0 jour suppl\u00e9mentaires consid\u00e9r\u00e9es comme mineures.<\/p>\n<p><strong>Renseignements sur le webinaire <\/strong><\/p>\n<p>Sant\u00e9&nbsp;Canada organisera une s\u00e9ance d\u2019information gratuite le <strong>22&nbsp;juillet&nbsp;2020 <\/strong>pour les intervenants, afin de fournir des renseignements suppl\u00e9mentaires sur le <em>R\u00e8glement sur les aliments et drogues<\/em> amend\u00e9.<\/p>\n<p>L\u2019objectif du webinaire est de mettre en \u00e9vidence les renseignements importants li\u00e9s aux modifications au <em>R\u00e8glement sur les aliments et drogues <\/em>et de fournir une tribune libre pour poser des questions.<\/p>\n<p>Pour participer \u00e0 la s\u00e9ance d\u2019information, vous devez vous inscrire \u00e0 l\u2019avance, car le nombre de participants est restreint (environ 200&nbsp;participants).<\/p>\n<p><strong>Pour vous inscrire \u00e0 la s\u00e9ance en anglais du 22&nbsp;juillet, allez \u00e0 <\/strong><strong><a href=\"https:\/\/gts-ee.webex.com\/mw3300\/mywebex\/default.do?service=1&amp;siteurl=gts-ee&amp;nomenu=true&amp;main_url=%2Fmc3300%2Fe.do%3Fsiteurl%3Dgts-ee%26AT%3DMI%26EventID%3D870794092%26UID%3D530098087%26Host%3DQUhTSwAAAARIz83SDbrRohwOgp0NpkngAN_BCTtbRDY8NLY1qiY2Mtw9E3qzEghDJ_aoChYdHvJmz9njuPzE3TncusBTnswl0%26RG%3D1%26FrameSet%3D2%26RGID%3Dr86a5f7e97e1435eb9e99287310f7bd85\" target=\"_blank\" rel=\"noopener noreferrer\">Inscription.<\/a><\/strong><\/p>\n<p><strong>Pour vous inscrire \u00e0 la s\u00e9ance en fran\u00e7ais du 22&nbsp;juillet, allez \u00e0 <\/strong><strong><a href=\"https:\/\/gts-ee.webex.com\/mw3300\/mywebex\/default.do?service=1&amp;siteurl=gts-ee&amp;nomenu=true&amp;main_url=%2Fmc3300%2Fe.do%3Fsiteurl%3Dgts-ee%26AT%3DMI%26EventID%3D870794002%26UID%3D530098087%26Host%3DQUhTSwAAAASthSOpvehhjf55i2z3mEP8u0H60WkPPvX6_0B_8JPHXJgYQOUGwGm-LK9UctGmyM9DzZW00YSEpE6e3-Q3zk1k0%26RG%3D1%26FrameSet%3D2%26RGID%3Dr2e504093ec9b5ab5f227e0bde15029b1\" target=\"_blank\" rel=\"noopener noreferrer\">Inscription<\/a><\/strong><strong>. <\/strong><\/p>\n<p>Une fois que l\u2019h\u00f4te aura approuv\u00e9 votre inscription, vous recevrez un courriel de confirmation contenant des instructions pour vous joindre \u00e0 la s\u00e9ance.<\/p>\n<p>Vous pouvez envoyer un courriel \u00e0 hc.gmp.conditions-bpf.sc@canada.ca pour obtenir plus de pr\u00e9cisions concernant les mesures provisoires et les produits auxquels elles s\u2019appliquent.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sant\u00e9&nbsp;Canada a annonc\u00e9 que des modifications au R\u00e8glement sur les aliments et drogues entreront en vigueur le 1er&nbsp;juillet 2020 dans le cadre de l\u2019Accord&nbsp;Canada-\u00c9tats-Unis-Mexique (ACEUM). Les modifications refl\u00e8tent plusieurs des flexibilit\u00e9s, y compris l\u2019\u00e9limination des exigences de duplication des tests et la permission pour l\u2019exp\u00e9dition directe de certains m\u00e9dicaments en vente libre. Dans le cadre<a class=\"excerpt-read-more\" href=\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/\" title=\"ReadModifications au R\u00e8glement sur les aliments et drogues de Sant\u00e9\u00a0Canada et webinaire \u00e0 venir\">&#8230; Read more &raquo;<\/a><\/p>\n","protected":false},"author":45,"featured_media":51077,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"class_list":["post-51079","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nouvelles-de-la-reglementation-canadienne"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Modifications au R\u00e8glement sur les aliments et drogues de Sant\u00e9\u00a0Canada et webinaire \u00e0 venir - Livingston International<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Modifications au R\u00e8glement sur les aliments et drogues de Sant\u00e9\u00a0Canada et webinaire \u00e0 venir - Livingston International\" \/>\n<meta property=\"og:description\" content=\"Sant\u00e9&nbsp;Canada a annonc\u00e9 que des modifications au R\u00e8glement sur les aliments et drogues entreront en vigueur le 1er&nbsp;juillet 2020 dans le cadre de l\u2019Accord&nbsp;Canada-\u00c9tats-Unis-Mexique (ACEUM). Les modifications refl\u00e8tent plusieurs des flexibilit\u00e9s, y compris l\u2019\u00e9limination des exigences de duplication des tests et la permission pour l\u2019exp\u00e9dition directe de certains m\u00e9dicaments en vente libre. Dans le cadre... Read more &raquo;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/\" \/>\n<meta property=\"og:site_name\" content=\"Livingston International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/livingstoninternational\" \/>\n<meta property=\"article:published_time\" content=\"2020-07-14T23:49:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-07-25T23:52:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/lii-mkt-content.s3.amazonaws.com\/livingston-content\/uploads\/2020\/07\/25225358\/webinar-3.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"567\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Francois\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Francois\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/\"},\"author\":{\"name\":\"Francois\",\"@id\":\"https:\/\/staging.livingstonintl.com\/fr\/#\/schema\/person\/9a3a9f1c26e1ee9e07c2500378871463\"},\"headline\":\"Modifications au R\u00e8glement sur les aliments et drogues de Sant\u00e9\u00a0Canada et webinaire \u00e0 venir\",\"datePublished\":\"2020-07-14T23:49:00+00:00\",\"dateModified\":\"2020-07-25T23:52:19+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/\"},\"wordCount\":882,\"commentCount\":0,\"image\":{\"@id\":\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/lii-mkt-content.s3.amazonaws.com\/livingston-content\/uploads\/2020\/07\/25225358\/webinar-3.jpg\",\"articleSection\":[\"Nouvelles de la r\u00e9glementation canadienne\"],\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/\",\"url\":\"https:\/\/staging.livingstonintl.com\/fr\/health-canada-food-and-drug-regulatory-amendments-and-upcoming-webinar\/\",\"name\":\"Modifications au R\u00e8glement sur les aliments et drogues de Sant\u00e9\u00a0Canada et webinaire \u00e0 venir - 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Les modifications refl\u00e8tent plusieurs des flexibilit\u00e9s, y compris l\u2019\u00e9limination des exigences de duplication des tests et la permission pour l\u2019exp\u00e9dition directe de certains m\u00e9dicaments en vente libre. Dans le cadre... 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