Edqm.eu

European Directorate for the Quality of Medicines & HealthCare

WEBThe EDQM is a leading organisation that protects public health by: enabling the development, supporting the implementation and monitoring the application of quality …

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URL: https://www.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 …

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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 …

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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 2024 and is no longer available on our website, except via the Archives (with the current valid licence).Visit our webstore to buy your licence.More information available on our website …

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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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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 (including the United Kingdom but not including Ukraine). Some non-EU states may have additional requirements. A current list of the Ph. Eur. members is available on the EDQM website.

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Products & services

WEBTechnical guides Ph. Eur. Blood guide. Organs guide. Tissues and cells technical guide. Cosmetics & Tattooing. Food contact materials and articles guide. Overview of …

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Certification of Suitability (CEP)

WEBCEP holders invited to comment on draft monographs published in Pharmeuropa 36.2. EDQM Strasbourg, France 08/04/2024. Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are

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N-nitrosamine contamination in brief

WEBRevised general monographs 2034 and 2619 with new paragraphs on control of N-nitrosamines. At its 174th session in November 2022, the European …

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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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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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