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 AgencyFri, 10 May 2024 09:12:08 +0200Fri, 26 Apr 2024 13:41:00 +0200Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-anonymisation-protected-personal-data-assessment-commercially-confidential-information-during-preparation-rmps-main-body-annexes-4-6_en.pdfGuidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-anonymisation-protected-personal-data-assessment-commercially-confidential-information-during-preparation-rmps-main-body-annexes-4-6_en.pdfFri, 26 Apr 2024 13:41:00 +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.pdfThu, 25 Apr 2024 16:11:00 +0200Regulatory and procedural guidelines (human and veterinary)Table 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.pdfTue, 23 Apr 2024 12:08:00 +0200Regulatory and procedural guidelines (human and veterinary)