Edqm.eu

European Pharmacopoeia (Ph. Eur.) 11th Edition

WEBThe primary source for quality control standards. The European Pharmacopoeia (Ph. Eur.) is the primary source of official quality standards for …

Actived: 6 days ago

URL: https://www.edqm.eu/en/web/edqm/european-pharmacopoeia-ph.-eur.-11th-edition

European Pharmacopoeia Online

WEBEuropean Pharmacopoeia Online. EUROPEAN PHARMACOPOEIA. The current valid subscription is 11.3-11.5. Subscription11.0-11.2 has been obsolete since 1 January …

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Ph. Eur. Reference Standards: Orders and Catalogue

WEBIn order to ensure that reference to the EDQM Reference Standards is correctly reported, the EDQM would like to remind users that they have an obligation to ensure that any …

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Which countries accept certificates of suitability

WEBAnswer: Certificates of suitability (CEPs) are accepted in all EU member states and in signatories to the Convention on the elaboration of a European Pharmacopoeia …

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Pharmacopoeial Harmonisation

WEBThe PDG was formed in 1989 by the European Directorate for the Quality of Medicines of the Council of Europe (the forerunner of the EDQM), the Japanese Pharmacopoeia of …

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New general chapter on Phage therapy medicinal products (5.31) …

WEBRising levels of antimicrobial resistance in recent years, identified as one of the leading threats to global public health and development, have prompted renewed interest in the …

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Certification Policy Documents & Guidelines

WEBContent of a dossier Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 7R, March 2024; Content of the Dossier for a Substance for TSE …

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CONTENT OF THE DOSSIER FOR A SUBSTANCE FOR TSE RISK …

WEBA new CEP application should contain three modules (modules 1, 2 and 3). Module 1 should contain a cover letter, a duly filled in application form including relevant declarations.

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The European Pharmacopoeia Commission

WEBComposition of the Ph. Eur. Commission. The Commission is composed of the delegations representing the contracting parties to the Convention on the Elaboration of a European …

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Ph. Eur. Technical Guides

WEBNEW Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances (2023) Technical Guide for the …

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Suspension or withdrawal of a certificate of suitability

WEBThis document describes the policy of the EDQM for suspension or withdrawal of a certificate of suitability (CEP) and for closure of a CEP application in accordance with …

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Newsletter Transplant

WEBNewsletter Transplant. Volume 28, October 2023. The Newsletter Transplant is an annual publication presenting international figures on organ, tissue and …

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