Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe 8 August 2022 All news https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/substance-product-data-management-services
Covid-19 Vaccine Surveillance Update – Period 17-Jun-2022 to 21-Jul-2022 5 August 2022 All news https://ansm.sante.fr/actualites/point-de-situation-sur-la-surveillance-des-vaccins-contre-le-covid-19-periode-du-17-06-2022-au-21-07-2022
The risk of myocarditis is increased but remains low after the first booster dose with an mRNA vaccine, and this risk decreases with increasing time between doses 1 August 2022 All news https://ansm.sante.fr/actualites/le-risque-de-myocardite-est-augmente-mais-reste-faible-apres-la-premiere-dose-de-rappel-par-un-vaccin-a-arnm-et-ce-risque-diminue-avec-lallongement-du-delai-entre-les-doses
EU : list of medicinal products under additional monitoring 29 July 2022 All news EU_list-medicinal-products-under-additional-monitoring_en-0_22Jul2022-1Télécharger
Oral methotrexate medicines (Imeth, Novatrex and generics): a patient card and a health professional brochure to avoid overdose 25 July 2022 All news https://ansm.sante.fr/actualites/medicaments-a-base-de-methotrexate-par-voie-orale-imeth-novatrex-et-generiques-une-carte-patients-et-une-brochure-professionnels-de-sante-pour-eviter-les-surdosages
Croatia-Minor changes to the procedure of DSUR submission 18 July 2022 All news Croatia-Minor-changes-to-the-procedure-of-DSUR-submission_Jul2022-1Télécharger
Belgium-FAQ_Unmet medical need_28Jun2022 15 July 2022 All news Belgium-FAQ_Unmet-medical-need_v1.12_-28Jun2022-1Télécharger
Austria : Pharmacovigilance in clinical trials_23Jun2022 11 July 2022 All news Austria-Pharmacovigilance-in-clinical-trials_updated-23Jun2022-1Télécharger
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022 8 July 2022 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-july-2022
Meeting highlights from thePharmacovigilance Risk AssessmentCommittee (PRAC) 7-10 June 2022 4 July 2022 All news Meeting-highlights-from-the-Pharmacovigilance-Risk-Assessment-Committee-PRAC-7-10-June-2022-_-European-Medicines-Agency-1Télécharger
