Regulatory and procedural guidelines (human and veterinary)https://www.ema.europa.eu/en/homepageRegulatory and procedural guidelines (human and veterinary)en-gbCopyright: (C) European Medicines AgencyWed, 17 Jul 2024 12:13:51 +0200Mon, 15 Jul 2024 11:59:00 +0200Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Grouphttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/table-decisions-labelling-exemption-requests-falling-under-article-63-directive-2001-83-ec-examined-quality-review-documents-qrd-group_en.pdfTable of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Grouphttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/table-decisions-labelling-exemption-requests-falling-under-article-63-directive-2001-83-ec-examined-quality-review-documents-qrd-group_en.pdfMon, 15 Jul 2024 11:59:00 +0200Regulatory and procedural guidelines (human and veterinary)Procedural advice on paediatric applicationshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-paediatric-applications_en.pdfProcedural advice on paediatric applicationshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-paediatric-applications_en.pdfTue, 09 Jul 2024 12:02:00 +0200Regulatory and procedural guidelines (human and veterinary)Member states contact points for translations reviewhttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/member-states-contact-points-translations-review_en.pdfMember states contact points for translations reviewhttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/member-states-contact-points-translations-review_en.pdfTue, 09 Jul 2024 10:21:00 +0200Regulatory and procedural guidelines (human and veterinary)Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2024https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/pharmacovigilance-related-regulatory-recommendations-centrally-authorised-veterinary-medicinal-products-during-2024_en.pdfPharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2024https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/pharmacovigilance-related-regulatory-recommendations-centrally-authorised-veterinary-medicinal-products-during-2024_en.pdfTue, 02 Jul 2024 09:46:00 +0200Regulatory and procedural guidelines (human and veterinary)Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/products-management-services-pms-implementation-international-organization-standardization-iso-standards-identification-medicinal-products-idmp-europe-chapter-7_en.pdfProducts Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/products-management-services-pms-implementation-international-organization-standardization-iso-standards-identification-medicinal-products-idmp-europe-chapter-7_en.pdfTue, 02 Jul 2024 09:35:00 +0200Regulatory and procedural guidelines (human and veterinary)List of centrally authorised products requiring a notification of a change for update of annexeshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/list-centrally-authorised-products-requiring-notification-change-update-annexes_en.pdfList of centrally authorised products requiring a notification of a change for update of annexeshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/list-centrally-authorised-products-requiring-notification-change-update-annexes_en.pdfFri, 21 Jun 2024 13:22:00 +0200Regulatory and procedural guidelines (human and veterinary)European Medicines Agency post-authorisation procedural advice for users of the centralised procedurehttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdfEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedurehttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdfFri, 21 Jun 2024 09:20:00 +0200Regulatory and procedural guidelines (human and veterinary)European Medicines Agency pre-authorisation procedural advice for users of the centralised procedurehttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en.pdfEuropean Medicines Agency pre-authorisation procedural advice for users of the centralised procedurehttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en.pdfFri, 21 Jun 2024 09:20:00 +0200Regulatory and procedural guidelines (human and veterinary)European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changeshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure-document-track-changes_en.pdfEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changeshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure-document-track-changes_en.pdfFri, 21 Jun 2024 09:20:00 +0200Regulatory and procedural guidelines (human and veterinary)European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changeshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure-document-tracked-changes_en.pdfEuropean Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changeshttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure-document-tracked-changes_en.pdfFri, 21 Jun 2024 09:20:00 +0200Regulatory and procedural guidelines (human and veterinary)