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AFMPS | Vos m茅dicaments et produits de sant茅
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class="page__section page__section--content" role="main"> <span id="main-content"></span> <div class="views-element-container block--news block block--views block--views--news-block-1 block--region-content" id="block-fagg-front-news"> <h2 class="block__title">Actualit茅</h2> <div><div class="view view--name-news view--display-block-1 view--id-news view--display-id-block_1 js-view-dom-id-9119e654f6f83dde25ce3940eb65186c30e367aed6b63db18c0103bee2fc5308"> <div class="view__content"> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/flash_vig_news_risque_de_meningiome_associe_aux_progestatifs_etat_de_la_question_et" rel="bookmark"> <span>Flash VIG-news : Risque de m茅ningiome associ茅 aux progestatifs : 茅tat de la question et recommandations</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-21T08:28:47Z" class="datetime">21/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Certains progestatifs ont 茅t茅 associ茅s 脿 un risque accru de m茅ningiome. L鈥橝FMPS souhaite rappeler aux professionnels de la sant茅 les mesures de minimisation du risque de m茅ningiome associ茅 脿 ces progestatifs.</div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/flash_vig_news_risque_de_meningiome_associe_aux_progestatifs_etat_de_la_question_et" rel="tag" title="Flash VIG-news : Risque de m茅ningiome associ茅 aux progestatifs : 茅tat de la question et recommandations" hreflang="fr">En savoir plus<span class="visually-hidden"> sur Flash VIG-news : Risque de m茅ningiome associ茅 aux progestatifs : 茅tat de la question et recommandations</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/les_nouveaux_formulaires_de_biovigilance_sont_disponibles" rel="bookmark"> <span>Les nouveaux formulaires de biovigilance sont disponibles</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-21T08:15:53Z" class="datetime">21/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Vous 锚tes un 茅tablissement de tissus ou un h么pital belge ? Vous devriez, d猫s 脿 pr茅sent, d茅clarer tous les incidents (SAE) et r茅actions (SAR) ind茅sirables graves 脿 la cellule Biovigilance de l鈥橝FMPS en utilisant les nouveaux formulaires.</div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/les_nouveaux_formulaires_de_biovigilance_sont_disponibles" rel="tag" title="Les nouveaux formulaires de biovigilance sont disponibles" hreflang="fr">En savoir plus<span class="visually-hidden"> sur Les nouveaux formulaires de biovigilance sont disponibles</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/appel_aux_laboratoires_belges_a_postuler_en_tant_que_laboratoire_de_reference_de_lunion_0" rel="bookmark"> <span>Appel aux laboratoires belges 脿 postuler en tant que laboratoire de r茅f茅rence de l鈥橴nion europ茅enne dans le domaine des dispositifs m茅dicaux de diagnostic in vitro </span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-19T10:07:36Z" class="datetime">19/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">La Commission europ茅enne a lanc茅 un second appel aux laboratoires des 脡tats membres 脿 soumettre des candidatures pour devenir un laboratoire de r茅f茅rence de l'Union europ茅enne pour les dispositifs m茅dicaux de diagnostic in vitro. La d茅signation de ces laboratoires est pr茅vue 脿 l'article 100 du r猫glement (UE) 2017/746 relatif aux dispositifs m茅dicaux de diagnostic in vitro.</div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/appel_aux_laboratoires_belges_a_postuler_en_tant_que_laboratoire_de_reference_de_lunion_0" rel="tag" title="Appel aux laboratoires belges 脿 postuler en tant que laboratoire de r茅f茅rence de l鈥橴nion europ茅enne dans le domaine des dispositifs m茅dicaux de diagnostic in vitro " hreflang="fr">En savoir plus<span class="visually-hidden"> sur Appel aux laboratoires belges 脿 postuler en tant que laboratoire de r茅f茅rence de l鈥橴nion europ茅enne dans le domaine des dispositifs m茅dicaux de diagnostic in vitro </span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/les_medicaments_de_therapie_innovante_non_reglementes_presentent_de_graves_risques_pour_la" rel="bookmark"> <span>Les m茅dicaments de th茅rapie innovante non r茅glement茅s pr茅sentent de graves risques pour la sant茅</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-19T08:33:11Z" class="datetime">19/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">L鈥橝FMPS, l'Agence europ茅enne des m茅dicaments (EMA) et le r茅seau des directeurs des agences europ茅ennes des m茅dicaments (Heads of European Medicine Agencies, HMA) mettent en garde le public contre les dangers des m茅dicaments de th茅rapie innovante non r茅glement茅s propos茅s aux patients dans l'Union europ茅enne, notamment les th茅rapies 脿 base de cellules dendritiques contre le cancer.</div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/les_medicaments_de_therapie_innovante_non_reglementes_presentent_de_graves_risques_pour_la" rel="tag" title="Les m茅dicaments de th茅rapie innovante non r茅glement茅s pr茅sentent de graves risques pour la sant茅" hreflang="fr">En savoir plus<span class="visually-hidden"> sur Les m茅dicaments de th茅rapie innovante non r茅glement茅s pr茅sentent de graves risques pour la sant茅</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/remise_dechantillons_de_medicaments_a_usage_veterinaire_publication_de_la_circulaire_657" rel="bookmark"> <span>Remise d鈥櫭ヽhantillons de m茅dicaments 脿 usage v茅t茅rinaire : publication de la circulaire 657 expliquant les r猫gles de cette fourniture et la communication des donn茅es 脿 l鈥橝FMPS</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-11T11:28:38Z" class="datetime">11/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">L鈥檃rr锚t茅 royal du 22 septembre 2024 relatif 脿 la publicit茅 pour les m茅dicaments 脿 usage v茅t茅rinaire pr茅cise notamment les r猫gles concernant la remise d鈥櫭ヽhantillons de m茅dicaments 脿 usage v茅t茅rinaire. La circulaire n掳 657 fournit les informations pratiques pour appliquer et respecter ces r猫gles. </div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/remise_dechantillons_de_medicaments_a_usage_veterinaire_publication_de_la_circulaire_657" rel="tag" title="Remise d鈥櫭ヽhantillons de m茅dicaments 脿 usage v茅t茅rinaire : publication de la circulaire 657 expliquant les r猫gles de cette fourniture et la communication des donn茅es 脿 l鈥橝FMPS" hreflang="fr">En savoir plus<span class="visually-hidden"> sur Remise d鈥櫭ヽhantillons de m茅dicaments 脿 usage v茅t茅rinaire : publication de la circulaire 657 expliquant les r猫gles de cette fourniture et la communication des donn茅es 脿 l鈥橝FMPS</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/le_rapport_annuel_de_biovigilance_2023_est_desormais_disponible" rel="bookmark"> <span>Le rapport annuel de biovigilance 2023 est d茅sormais disponible</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-06T06:52:38Z" class="datetime">06/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">La biovigilance assure une surveillance syst茅matique, depuis la s茅lection du donneur jusqu'au suivi du receveur, afin de garantir une utilisation plus s没re et plus efficace des tissus et cellules. Dans ce rapport 2023, tous les SAE et SAR survenus lors du traitement et de l鈥檜tilisation de SoHO du 1e janvier 2023 au 30 juin 2024 ont 茅t茅 compil茅s.</div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/le_rapport_annuel_de_biovigilance_2023_est_desormais_disponible" rel="tag" title="Le rapport annuel de biovigilance 2023 est d茅sormais disponible" hreflang="fr">En savoir plus<span class="visually-hidden"> sur Le rapport annuel de biovigilance 2023 est d茅sormais disponible</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/cybersecurite_lafmps_appelle_les_entreprises_et_organisations_a_senregistrer_dans_le_cadre_de" rel="bookmark"> <span>Cybers茅curit茅 : l鈥橝FMPS appelle les entreprises et organisations 脿 s鈥檈nregistrer dans le cadre de NIS2</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-03T12:13:39Z" class="datetime">03/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Suite 脿 l鈥檈ntr茅e en vigueur de la loi NIS2, il est essentiel que toutes les entreprises et organisations en Belgique v茅rifient si elles entrent dans le champ d鈥檃pplication de la nouvelle loi. Utilisez le Scope Test Tool pour savoir si votre organisation doit se conformer 脿 cette nouvelle l茅gislation. Si c鈥檈st le cas, elle doit 锚tre enregistr茅e dans la plate-forme Safeonweb@work avant le 18 mars 2025.</div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/cybersecurite_lafmps_appelle_les_entreprises_et_organisations_a_senregistrer_dans_le_cadre_de" rel="tag" title="Cybers茅curit茅 : l鈥橝FMPS appelle les entreprises et organisations 脿 s鈥檈nregistrer dans le cadre de NIS2" hreflang="fr">En savoir plus<span class="visually-hidden"> sur Cybers茅curit茅 : l鈥橝FMPS appelle les entreprises et organisations 脿 s鈥檈nregistrer dans le cadre de NIS2</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/fr/news/lalliance_pour_les_medicaments_critiques_formule_des_recommandations_pour_remedier_aux" rel="bookmark"> <span>L鈥橝lliance pour les m茅dicaments critiques formule des recommandations pour rem茅dier aux p茅nuries de m茅dicaments au niveau europ茅en</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-02-28T12:31:28Z" class="datetime">28/02/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Cr茅茅e en avril 2024 sous la pr茅sidence belge du Conseil de l鈥橴nion europ茅enne, l鈥橝lliance pour les m茅dicaments critiques vise 脿 favoriser la collaboration entre d茅cideurs politiques et parties prenantes. Son objectif est de d茅velopper un syst猫me solide et r茅actif pour l鈥檃pprovisionnement en m茅dicaments critiques dans l鈥橴nion europ茅enne. Ce 28 f茅vrier 2025, l鈥檃lliance pr茅sente son rapport. Ce rapport constituera la base de l鈥檃cte l茅gislatif sur les m茅dicaments critiques, la nouvelle l茅gislation europ茅enne sur les p茅nuries de m茅dicaments.</div> <div class="node__links"> <ul class="links inline"><li><a href="/fr/news/lalliance_pour_les_medicaments_critiques_formule_des_recommandations_pour_remedier_aux" rel="tag" title="L鈥橝lliance pour les m茅dicaments critiques formule des recommandations pour rem茅dier aux p茅nuries de m茅dicaments au niveau europ茅en" hreflang="fr">En savoir plus<span class="visually-hidden"> sur L鈥橝lliance pour les m茅dicaments critiques formule des recommandations pour rem茅dier aux p茅nuries de m茅dicaments au niveau europ茅en</span></a></li></ul> </div> </div> </article> </div> </div> <div class="more-link"><a href="/fr/actualites">Lire plus</a></div> </div> </div> </div> <article class="node node--type-page node--view-mode-full node--promoted"> <div class="node__content"> </div> </article> <div id="block-block-65" class="block block--block-content block--block-content--basic--full block--region-content-bottom"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p><a href="https://www.facebook.com/AFMPS.be/"><img alt="Picture_FB" data-entity-type="image" data-entity-uuid="0" src="/sites/default/files/FB.png"></a> <a href="https://twitter.com/AFMPS_be"><img alt="Picture_X_Twitter" data-entity-type="image" data-entity-uuid="0" src="/sites/default/files/X_Twitter.png"></a> <a href="https://www.linkedin.com/company/808980/"><img alt="Picture_Linkin" data-entity-type="image" data-entity-uuid="0" src="/sites/default/files/Linkin.png"></a></p> </div> </div> </main> <div class="page__section page__section--sidebar-second"> <div id="block-pharmainfo-bloc" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight"><a href="https://www.pharmainfo.be/"><img alt="Pharmainfo_picture" data-entity-type="image" data-entity-uuid="0" height="113" src="/sites/default/files/Pharmainfo.png" width="403" loading="lazy"></a></div> </div> </div> <div id="block-coronavirusfr" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight"> <h3><a href="node/109645" target="_blank">Coronavirus (Covid-19)</a></h3> </div> </div> </div> <div id="block-blocnoticefr" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="block-search"> <h2>Chercher des informations sur un m茅dicament autoris茅 </h2> <p class="MsoNormal"><span lang="EN-US" style="mso-ansi-language:EN-US">(notice, RCP, RMA, DHPC, s-RMP)<o:p></o:p></span></p> <p class="rtecenter"><a href="https://basededonneesdesmedicaments.be/usage-humain" target="_blank">Chercher</a></p> </div> </div> </div> <div id="block-blocbasededonneesautorisesfr" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-3"> <h3>Base de donn茅es des m茅dicaments suspendus </h3> <ul> <li><a href="https://basededonneesdesmedicaments.be/usage-humain/apercu/medicaments-dont-autorisation-est-suspendue" target="_blank">脿 usage humain</a></li> <li><a href="https://basededonneesdesmedicaments.be/usage-veterinaire/apercu/medicaments-dont-autorisation-est-suspendue">脿 usage v茅t茅rinaire</a></li> </ul> </div> </div> </div> <div id="block-blocdisponibilitemedicamentfr" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="block-search"> <h2>Chercher des informations sur la disponibilit茅 d'un m茅dicament</h2> <p class="rtecenter"><a href="https://www.afmps.be/fr/items-HOME/indisponibilites_de_medicaments" target="_blank">Information g茅n茅rale</a></p> <p class="rtecenter"><a href="https://pharmastatut.be/" target="_blank">Chercher un m茅dicament</a></p> </div> </div> </div> <div id="block-block-99" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-3"> <h3><a href="/node/106704" target="_blank">Portail web </a></h3> </div> </div> </div> <div id="block-block-108" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-3"> <h3><a href="https://banquededonneesessaiscliniques.be/" target="_blank">Base de donn茅es des essais cliniques</a></h3> </div> </div> </div> <div id="block-block-84" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-2"> <h3>Vous voulez notifier un probl猫me concernant un m茅dicament 脿 usage humain ?</h3> <ul> <li><a href="https://www.afmps.be/fr/effet_indesirable">Effet ind茅sirable</a></li> <li><a href="/node/106823">Abus</a></li> <li><a href="/node/106826">Erreur m茅dicamenteuse</a></li> <li><a href="/node/106827">D茅faut de qualit茅</a></li> </ul> </div> </div> </div> <div id="block-block-86" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-2"> <h3>Notification d'effets/ r茅actions ind茅sirables et/ou d'incidents</h3> <ul> <li><a href="https://www.afmps.be/fr/usage_veterinaire/medicaments/medicaments/pharmacovigilance/notifier_des_effets_indesirables_de">M茅dicament 脿 usage v茅t茅rinaire </a></li> <li><a href="https://www.afmps.be/fr/humain/produits_de_sante/dispositifs_medicaux/materiovigilance">Dispositif m茅dical et/ou accessoire</a></li> <li><a href="https://www.afmps.be/fr/humain/produits_de_sante/sang_et_produit_sanguin/hemovigilance">Sang ou compos茅 sanguin</a></li> <li><a href="https://www.afmps.be/fr/humain/produits_de_sante/materiel_corporel_humain/biovigilance">Mat茅riel corporel humain (tissus, cellules)</a></li> </ul> </div> </div> </div> <div id="block-block-53" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-1"> <h3><a href="https://www.pharmastatut.be/" target="_blank">Notifications concernant la mise sur le march茅 d'un m茅dicament via PharmaStatut</a></h3> </div> </div> </div> <div id="block-block-57" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="text-highlight"> <h2>Autres th猫mes</h2> <ul> <li> <h3><a href="/fr/items-HOME/Circulaires">Circulaires</a></h3> </li> <li> <h3><a href="/fr/comites">Comit茅s</a></h3> </li> <li> <h3><a href="/fr/commissions">Commissions</a></h3> </li> <li> <h3><a href="/fr/doi">D茅clarations 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