Téléchargements
Bienvenue dans la section "Téléchargements" de notre site internet.
Accès pour clients existants
Pharmacopée européenne en ligne
Guides cosmétiques & d’emballage
Accès gratuits
Veuillez lire les instructions ci-dessous
Le site de la DEQM contient un certain nombre de fichiers et de formulaires, qui peuvent être téléchargés à l'aide de Microsoft Word (DOC) ou Adobe PDF (Portable Document Format).
Pour accéder aux fichiers PDF, vous devez avoir une copie d'Acrobat Reader sur votre ordinateur, qui est disponible gratuitement sur le site d'Adobe (voir http://www.adobe.com). Pour ouvrir un document, il suffit de cliquer sur le lien correspondant et attendre que votre ordinateur ait téléchargé le document.
Note : L'adresse e-mail se termine "@edqm.eu" (remplace le "@ pheur.org"). L'adresse e-mail "info@edqm.eu" n'est plus valide. Pour contacter la DEQM, merci d'utiliser le HelpDesk de la DEQM.
Accès spécifique
Concernant les Archives de Pharmeuropa et de Pharmeuropa Bio & Scientific Notes :
-
Pour consulter les archives de Pharmeuropa, voir Archives de Pharmeuropa.
-
Pour consulter les archives de Pharmeuropa Bio & Scientific Notes, Voir Pharmeuropa Bio & Scientific Notes.
Veuillez noter qu'il est nécessaire de s'inscrire pour accéder à cette publication en ligne gratuite.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pour trouver l'information que vous cherchez, cliquez sur le thème qui vous intéresse : par exemple, "Certification" ou "OMCL Activities & Guidelines".
- EDQM HealthCare European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk Other
- Plan d\'accès
- Presentation material
- EDQM Brochure
- Brochure de la DEQM (mise à jour : juillet 2011)
Présentation de la DEQM
- Brochure de la DEQM (mise à jour : juillet 2011)
- Annual Report of Activities
- EDQM Brochure
- Press releases
- Quality, Safety and Environment
- Safety
- Consultation Publique Classification des dangers
Consultation publique au sujet de la mise en application du Système Général Harmonisé de l\'ONU (GHS) relatif à la classification des dangers pour les étalons de référence - Table: EDQM Consultation GHS
NOTE: This document has 183 pages.
- Consultation Publique Classification des dangers
- Environment
- Safety
- Library
- Visits
- HealthCare EDQM European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk Other
- 2- Blood Transfusion
- General
- Activités en transfusion sanguine
- Factsheet on Blood Transfusion Activities (Spanish)
- Informations générales sur les activités de la DEQM liées à la transfusion sanguine (anglais /français, 2011)
- List of Members - CD-P-TS
- List of Members of the ad-hoc Working Group - Blood Transfusion Guide (GTS)
- Leaflet of Organ Transplantation Activities (English - Spanish)
- Mandat du comité CD-P-TS
- Pandemic Influenza - Planning for Blood Organisations
Consolidating the work of the European Blood Alliance Emergency Planning Action Group (EBA EPAG) (May 2009) - Terms of Reference CD-P-TS
- Recommendations
- Transfusion Sanguine Recommandations (téléchargez toutes les recommandations, Français)
- Mémoire explicatif de la Recommandation Rec(2004)18
- Recommandation Rec(2004)18 du Comité des Ministres aux Etats membres relative à l’enseignement de la médecine transfusionnelle au personnel infirmier
- Recommandation Rec(2004)8 du Comité des Ministres aux Etats membres sur les banques de sang de cordon autologue
- Explanatory Memorandum to the Recommendation Rec(2004)8
- Recommandation Rec(2003)11 du Comité des Ministres aux Etats membres sur la mise en place de procédures d’inactivation des agents pathogènes pour les composants sanguins
- Recommandation Rec(2002)11 du Comité des Ministres aux Etats membres sur le rôle de l’hôpital et du clinicien s’agissant de garantir l’usage optimal du sang et des produits sanguins
- Recommandation Rec(2001)4 du Comité des Ministres aux Etats membres sur la prévention du risque de transmission de la forme nouvelle de la maladie de Creutzfeldt-Jakob (vMCJ) par transfusion sanguine
- Recommandation No R(98)10 du Comité des Ministres aux Etats membres sur l\'utilisation de concentrés érythrocytaires humains pour la préparation de transporteurs d\'oxygène
- Recommandation No R(98) 2 du Comité des Ministres aux Etats membres sur la production de progéniteurs hématopoïétiques
- Recommandation No R(96) 11 du Comité des Ministres aux Etats membres sur la documentation et l\'archivage destinés à garantir le suivi du sang et des produits sanguins, notamment dans les hôpitaux
- Recommandation No R(95) 15 du Comité des Ministres aux Etats membres sur la préparation, l\'utilisation et l\'assurance de qualité des composants sanguins
- Recommandation No R(95) 14 du Comité des Ministres aux Etats membres sur la protection de la santé des donneurs et des receveurs dans le cadre de la transfusion sanguine
- Recommandation No R(94) 10 du Comité des Ministres aux Etats membres sur l\'intervention pharmacologique précoce en cas d\'infection par le VIH
- Recommandation No R (93) 4 du Comité des Ministres aux États membres aux essais cliniques nécessitant l\'utilisation de composants et de produits issus du fractionnement du sang et du plasma humains
- Recommandation No R(90) 9 du Comité des Ministres aux Etats membres sur les produits plasmatiques et l\'autosuffisance européenne
- Recommandation No R(90) 3 du Comité des Ministres aux Etats membres sur la recherche médicale sur l\'etre humain
- Recommandation No R(89) 14 du Comité des Ministres aux Etats membres sur les incidences éthiques de l\'infection VIH dans le cadre sanitaire et social
- Recommandation No R(88) 4 du Comité des Ministres aux Etats membres sur les responsabilités sanitaires dans le domaine de la transfusion sanguine
- Recommandation No R(87) 25 du Comité des Ministres aux Etats membres concernant une politique européenne commune de santé publique de lutte contre le syndrome d\'immunodéficience acquise (SIDA)
- Recommandation No R(86) 6 du Comité des Ministres aux Etats membres relative aux lignes directrices pour la préparation, le contrôle de qualité et l\'utilisation du plasma frais congelé (PFC)
- Recommandation No R(85) 12 du Comité des Ministres aux Etats membres sur le dépistage de la présence de marqueurs du SIDA chez les donneurs de sang
- Recommandation No R(85) 5 du Comité des Ministres aux Etats membres relative à un modèle de programme pour la formation des futurs spécialistes en transfusion sanguine
- Recommandation No R(84) 16 du Comité des Ministres aux Etats membres concernant la notification des travaux impliquant de l\'acide désoxyribonucléique (ADN) recombiné
- Recommandation No R(84) 6 du Comité des Ministres aux Etats membres sur la prévention de la transmission du paludisme par la transfusion sanguine
- Recommandation No R(83) 8 du Comité des Ministres aux Etats membres sur la prévention de la transmission possible du syndrome d\'immunodépression acquise (SIDA) des donneurs contaminés aux receveurs de sang ou de produits sanguins
- Recommandation No R(81) 14 du Comité des Ministres aux Etats membres sur la prévention de la transmission de maladies infectieuses dans le transfert international du sang, de ses composants et de ses dérivés
- Recommandation No R(81) 5 du Comité des Ministres aux Etats membres concernant l\'administration prénatale de l\'immunoglobuline anti-D
- Recommandation No R(80) 5 du Comité des Ministres aux Etats membres concernant les produits sanguins pour le traitement des hémophilies
- Recommandation No R(79) 5 du Comité des Ministres aux Etats membres concernant le transport et l\'échange internationaux de substances d\'origine humaine
- Reports
- Techniques de réduction des pathogènes dans les composants sanguins destinés à la transfusion - mise à jour mars 2008
- The Collection, Testing and Use of Blood and Blood Components in Europe - 2008 Report
- The Collection, Testing and Use of Blood and Blood Components in Europe - 2007 Report
- Reporting from Council of Europe member states on the collection, testing and use of blood and blood components in Europe : 2006 Survey
- Reporting from Council of Europe member states on the collection, testing and use of blood and blood components in Europe: The 2003 Survey
- Trends and Observations on the Collection, Testing and Use of Blood Components: 2001-2005 Report
- The Collection, Testing and Use of Blood and Blood Components in Europe - 2006 Report
- Collecte, qualification et utilisation du sang et des composants sanguins en Europe - Rapport 2005
- The Collection, Testing and Use of Blood and Blood Components in Europe - 2004 Report
- La collecte, la qualification et l’utilisation du sang et des composants sanguins en Europe - Rapport 2004
- The Collection, Testing and Use of Blood and Blood Products in Europe in 2003
- The Collection, Testing and Use of Blood and Blood Products in Europe in 2002
- The Collection, Testing and Use of Blood and Blood Components in Europe in 2001
- Implementation of Pathogen Reduction Technologies for Blood Components for Transfusion: Updated Table 2009-2010
- Resolutions
- Résolution CM/Res(2008)5 sur la responsabilité des donneurs et sur la limitation du don du sang et des composants sanguins
Adoptée par le Comité des Ministres le 12 mars 2008, lors de la 1021e réunion des Délégués des Ministres - Resolution CM/Res(2008)5 on donor responsibility and on limitation to donation of blood and blood components
Adopted by the Committee of Ministers on 12 March 2008 at the 1021st meeting of the Ministers’ Deputies - Resolution 68 (32) Establishment in Amsterdam of a European blood bank of rare groups
Adopted by the Ministers Deputies on 31 October 1968
- Résolution CM/Res(2008)5 sur la responsabilité des donneurs et sur la limitation du don du sang et des composants sanguins
- General
- 3- Organ Transplantation
- General
- List of members CD-P-TO 28/01/13
- Terms Of Reference CD-P-TO
- Mandat Du Comité CD-P-TO
- The Declaration of Istanbul
Participants in the International Summit on Transplant Tourism and Organ Trafficking convened by The Transplantation Society and International Society of Nephrology in Istanbul, Turkey, April 30–May 2, 2008 - Activités liées à la transplantation d’organes Factsheet (Français, juin 2011)
- Activités liées à la transplantation d’organes (English/French, 2011)
- General Information on Organ Transplantation Activities (Eng/Russian, 2011)
- Photo promotion du don d\'organes 2011
octobre 2011
- Recommendations
- Transplantation d\'organes Recommandations (Francais)
- Recommandation Rec(2006)16 du Comité des Ministres aux Etats membres sur les programmes d amélioration de la qualité pour le don d organes
- Recommandation Rec(2006)15 du Comité des Ministres aux Etats membres sur le contexte, les fonctions et les responsabilités d’une organisation nationale de transplantation (ONT)
- Recommandation Rec(2005)11 du Comité des Ministres aux Etats membres sur le rôle et la formation des professionnels du don d’organes (« coordinateurs du prélèvement »)
- Recommandation Rec(2004)19 du Comité des Ministres aux Etats membres relative aux critères exigés pour l\'autorisation des centres de transplantations d\'organes
- Recommandation Rec(2004)7 du Comité des Ministres aux Etats membres sur le trafic d organes
- Recommandation Rec(2004)8 du Comité des Ministres aux Etats membres sur les banques de sang de cordon autologue
- Recommandation Rec(2003)12 du Comité des Ministres aux Etats membres relative aux registres des donneurs d’organes
- Explanatory memorandum to Recommendation Rec(2003)10
- Recommandation Rec(2003)10 du Comité des Ministres aux Etats membres sur la xénotransplantation
- Recommandation Rec(2001) 15 du Comité des Ministres aux Etats membres sur la gestion des listes d\'attente et des délais d\'attente en matière de transplantation d\'organe
- Recommandation No R (97) 16 du Comité des Ministres aux Etats membres sur la transplantation du foie prélevé sur des donneurs vivants apparentés
- Recommandation No R (97) 15 du Comité des Ministres aux Etats membres sur la xénotransplantation
- Recommandation No R (94) 1 du Comité des Ministres aux Etats membres sur les banques de tissus humains
- Reports
- Replies to the questionnaire for member states on organ trafficking
- Organ shortage:current status and strategies for improvement of organ donation - A European consensus document
- Joint Council of Europe/United Nations Study on trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs
- Résumé général de l\'Étude conjointe du Conseil de l’Europe et des Nations Unies
- Resolutions
- Resolution CM/Res(2008)6 on transplantation of kidneys from living donors who are not genetically related to the recipient
Adopted by the Committee of Ministers on 26 March 2008 at the 1022nd meeting of the Ministers’ Deputies - Résolution CM/Res(2008)6 sur la transplantation de rein de donneurs vivants qui ne sont pas génétiquement liés au receveur
Adoptée par le Comité de Ministres le 26 mars 2008, lors de la 1022e réunion des Délégués des Ministres - Resolution CM/Res(2008)4 on adult-to-adult living donor liver transplantation
Adopted by the Committee of Ministers on 12 March 2008 at the 1021st meeting of the Ministers Deputies - Résolution CM/Res(2008)4 sur la transplantation de foie de donneurs vivants entre adultes
Adoptée par le Comité de Ministres le 12 mars 2008, lors de la 1021e réunion des Délégués des Ministres - Resolution CM/Res(78) 29 on harmonisation of legislations of member states relating to removal, grafting and transplantation of human substances
Adopted by the Committee of Ministers on 11 May 1978 at the 287th meeting of the Ministers\' Deputies - Résolution CM/Res(78) 29 sur l\'harmonisation des législations des Etats membres relatives aux prélèvements, greffes et transplantations de substances d\'origine humaine
Adoptée par le Comité des Ministres le 11 mai 1978,
lors de la 287e réunion des Délégués des Ministres
- Resolution CM/Res(2008)6 on transplantation of kidneys from living donors who are not genetically related to the recipient
- Publications
- Booklet Rec Res Organ transplantation
- Newsletter Transplant
- Newsletter Transplant Vol. 17, No 1 Sept. 2012
- Newsletter Transplant Vol. 16, No 1 Sept. 2011
- Newsletter Transplant Vol. 15, No 1 Sept. 2010
- Newsletter Transplant Vol. 14, No 1 Sept. 2009
- Newsletter Transplant Vol. 13, No 1 Sept. 2008
- Newsletter Transplant Vol. 12, No 1 Sept. 2007
- Newsletter Transplant Vol. 11, No 1 Sept. 2006
- Newsletter Transplant Vol. 10, No 1 Sept. 2005
- Newsletter Transplant Vol. 9, No 1 Sept. 2004
- European Day for Organ Donation and Transplantation
- 2012
- 2011
- Brochure Transplantation d\'organes (Français)
- Organ Donation Brochure (Russian)
- Sticker (Français)
- Carte postale (Français)
Carte postale transplantation d\'organes - Introduction à l\'EODD
- Programme EODD
- 2010
- General
- 4- Pharmaceutical & Pharmaceutical Care
- General
- Résolution ResAP(2007)1 sur la classification des médicaments relativement à leurs conditions de délivrance
- Mandat du Comité européen sur les produits et les soins pharmaceutiques CD-P-PH
1101e réunion – 8 décembre 2010 - Mandat du Comité d’experts CD-P-PH/CMED
- Mandat du Comité d’experts CD-P-PH/PC
- Mandat du Comité d’experts CD-P-PH/PHO
- Reports
- 1101 Réunion, 8 décembre 2010
Comité européen sur les produits et les soins pharmaceutiques (Accord Partiel) (CD-P-PH) - Rapport abrégé de la 4e réunion (Bruxelles, 15-16 septembre 2010) - 1084 Réunion, 5 mai 2010
Comité européen sur les produits et les soins pharmaceutiques (Accord partiel) (CD-P-PH) –
Rapport abrégé de la 3e réunion (Strasbourg, 26-27 janvier 2010) - 1063 Réunion, 8 juillet 2009
Comité européen sur les produits et les soins pharmaceutiques (Accord partiel) (CD-P-PH) –
Rapport abrégé de la 2e réunion (Bruxelles, 2-3 avril 2009) - 1032 Réunion, 9 juillet 2008
Comité européen sur les produits et les soins pharmaceutiques (Accord partiel) (CD-P-PH) - Rapport abrégé de la 1e réunion (Strasbourg, 2-3 avril 2008) - 1137 Réunion, 14 mars 2012
- 1166 Réunion
- 1101 Réunion, 8 décembre 2010
- General
- 5- Counterfeit Medicines
- General
- Notification de contrefaçon de medicament
- Counterfeit Medicinal Product Notification Form
- Déclaration de Moscou
Conférence internationale : L\'Europe contre les médicaments contrefaits, 23-24 octobre 2006 - Moscow Declaration
International Conference - Europe against Counterfeit Medicines, 23-24 October 2006 - Un modele de reseau et de points de contact uniques (PCU)
Groupe ad hoc sur les médicaments contrefaits (P-SP-PH/CMED) - Model for a Network and Single Points of Contacts (SPOCs)
Ad hoc Group on Counterfeit Medicines (P-SP-PH/CMED) - Risk communication model
- Symposium consacré à la lutte contre les médicaments contrefaits et illégaux
Symposium consacré à la lutte contre les médicaments contrefaits et illégaux - Combattre la contrefaçon des produits médicinaux et les infractions similaires
Octobre 2011 - Convention médicrime conclusions de la conférence
- Pays signataires Medicrime
- Medicrime poster
- FS médicaments contrefaits
- A practical tool to fight at an international level the falsification of Medicines and similar crimes (European files, October 2012)
- Gabi journal
- Medicrime map Dec 2012 UK
- Counteract Counterfeiters Short Conclusions 2005
short conclusions symposium 21-23 September 2005
- Reports
- Resolutions
- eTACT
- General
- 6- Classification of Medicines
- General
- Resolutions
- Résolution ResAP(2007)1 sur la classification des médicaments relativement a leur conditions de delivrance - Edition 2010
Remplaçant la Résolution ResAP(2000)1 relative à la classification des médicaments dont la délivrance est soumise à ordonnance - Résolution ResAP(2007)1 sur la classification des médicaments relativement a leur conditions de delivrance - Edition 2010
Remplaçant la Résolution ResAP(2000)1 relative à la classification des médicaments dont la délivrance est soumise à ordonnance - Résolution ResAP(2007)1 sur la classification des médicaments relativement a leur conditions de delivrance - Edition 2009
Remplaçant la Résolution ResAP(2000)1 relative à la classification des médicaments dont la délivrance est soumise à ordonnance - Resolution ResAP(2007)2 English
Good practices for distributing medicines via mail order - Resolution ResAP(2007)2 French
Bonnes pratiques en matière de distribution des médicaments par correspondance - Resolution AP(2007) 1 English
(superseding Resolution ResAP(2000)1 on the classification of medicines which are obtainable only on medical prescription) and Appendices (2008 Edition) - Resolution AP (2007)1 French
(remplaçant la Résolution ResAP(2000)1 relative à la classification des médicaments dont la délivrance est soumise à ordonnance) et Annexes I, II & III
Edition 2008 - Resolution ResAP (2001)2 English
Pharmacists role in the framework of health security - Resolution ResAP (2001) 2 French
Role du pharmacien dans le cadre de la sécurité sanitaire - Resolution AP (2000) 1 English
on the Classification of medicines which are obtainable only on medical prescription, and Appendices (2006 Edition) - Resolution AP (2000) 1 English
on the Classification of medicines which are obtainable only on medical prescription, and Appendices (2005 Edition) - Resolution AP (2000) 1 English
on the Classification of medicines which are obtainable only on medical prescription, and Appendices (2004 Edition) - Résolution ResAP(2007)1 du Comité des Ministres sur la classification des médicaments relativement à leurs conditions de délivrance
- Résolution ResAP(2007)1 sur la classification des médicaments relativement a leur conditions de delivrance - Edition 2010
- 7- Quality and safety standards in pharmaceutical
- Conseil de lEurope Modèle Campagne
- Proceedings: Expert Meeting on Medication Safety, 21-22 November, The Hague
- Report 2006
Creation of a better medication safety culture in Europe: Building up safe medication practices, Expert Group on Safe Medication Practices (P-SP-PH/SAFE) - Abridged Survey Report on Quality and Safety Assurance Standards
- Medicines and the Internet
- Core message of user-oriented guidance (German)
- Core message of user-oriented guidance (Spanish)
- Vente et publicite des medicaments sur internet
Préparé par le Comité d’Experts des Questions Pharmaceutiques, le 13 novembre 2002 - Selling and advertising of medicines on the internet
Prepared by the Committee of Experts on Pharmaceutical Questions, 13 November 2002 - Workshop report - Medicines on the web:risks and benefits
UN Internet Governance Forum (IGF), Sharm El Sheik, 15-18 November 2009
- Cosmetics
- 2- Blood Transfusion
- European Pharmacopoeia & PDG EDQM HealthCare Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk Other
- European Pharmacopoeia
- NOUVEAU: L’immunoglobuline humaine normale pour administration par voie intraveineuse
01/2012:0918 - NOUVEAU : Mise en application rapide de la monographie (09) 18
septembre 2011 - NOUVEAU: Lettre circulaire concernant la mise en application rapide de la version revisée de la monographie 0918
- Héparine calcique (08/2010:0332)
Implementation date: 1st August 2010 - Héparine sodique (08/2010:0333)
Implementation date: 1st August 2010 - NMR test protocol for OSCS determination in API Heparin Sodium and Calcium
- Heparin: a new capillary electrophoresis method
- Héparine: une méthode électrophorèse capillaire
- Nouvelle expression des critères d’acceptation pour l’essai des substances apparentées
Informations générales pour des parties concernées - Recommandations relatives à la présentation des monographies de substances d\'origine humaine ou animale
Novembre 2010 - Mise en application rapide du chapitre général 5.2.8 révisé
- Réduction du risque de transmission des agents des encéphalopathies spongiformes animales par les médicaments à usage humain et vétérinaire
En application: 1er juillet 2011. - PhEur Commission Decisions
- 2012
- 2011
- 2010
- 2009
- Decisions Ph Eur Comm 122009
- Liste des textes adoptes Commission PhEur, décembre 2009
- Decisions Ph Eur Comm 062009
- List of texts adopted at PhEur Commission June 2009
- Liste des textes adoptes Commission PhEur, juin 2009
- Decisions Ph Eur Comm 032009
- List of texts adopted at PhEur Commission March 2009
- Décisions Ph Eur Comm 122009 (Français)
- 2008
- Decisions Ph Eur Comm 112008 (English)
- Décisions Ph Eur Comm 112008 (Français)
- Decisions Ph Eur Comm 062008 (English)
List of new or revised texts adopted by the PhEur Commission, June 2008 session - Décisions Ph Eur Comm 062008 (Francais)
Liste des textes adoptés à la session de juin 2008 de la Commission Européenne de Pharmacopée - Decisions Ph Eur Comm 032008 (English)
List of new or revised texts adopted by the PhEur Commission, March 2008 session - Décisions Ph Eur Comm 032008 (Francais)
Liste des textes adoptés à la session de novembre 2007 de la Commission Européenne de Pharmacopée
- 2007
- Decisions Ph Eur Comm 112007 (English)
List of new or revised texts adopted by the PhEur Commission, June 2007 session - Décisions Ph Eur Comm 112007 (Francais)
Liste des textes adoptés à la session de novembre 2007 de la Commission Européenne de Pharmacopée - Decisions Ph Eur Comm 062007
List of new or revised texts adopted by the PhEur Commission, June 2007 session - Decisions Ph Eur Comm 032007
List of new or revised texts adopted by the PhEur Commission, March 2007 session
- Decisions Ph Eur Comm 112007 (English)
- 2006
- Decisions Ph Eur Comm 112006
List of new or revised texts adopted by the PhEur Commission, November 2006 session - Decisions Ph Eur Comm 062006
List of new or revised texts adopted by the PhEur Commission, June 2006 session - Decisions Ph Eur Comm 032006
List of new or revised texts adopted by the PhEur Commission, March 2006 session
- Decisions Ph Eur Comm 112006
- 2005
- Decisions Ph Eur Com 062005
List of new or revised texts adopted by the PhEur Commission, June 2005 session - Decisions Ph Eur Com 112005
Decisions of the European Pharmacopoeia Commission, November 2005 (texts and CRS/BRP adopted and revisions of monographs and general texts)
- Decisions Ph Eur Com 062005
- 2004
- 12003
- Work Programme
- 2012
- 2011
- Mise à jour Programme de travail mars 2011
- Mise à jour du Programme de travail, Mars 2011
Mise à jour du Programme de travail, Mars 2011 - Mise à jour du programme de travail, juin 2011
- Liste des textes adoptés, juin 2011
- 2010
- 2009
- 2008
- Modification Work Programme 112008
- Mise à jour programme de travail 112008
- Mise à jour Programme de travail 062008
Mise à jour du programme de travail de la Pharmacopée Européenne (Décisions de la Commission Européenne de Pharmacopée, juin 2008) - Modification Work Programme 062008
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, June 2008) - Mise à jour Programme de travail 032008
Mise à jour du programme de travail de la Pharmacopée Européenne (Décisions de la Commission Européenne de Pharmacopée, mars 2008) - Modification Work Programme 032008
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, March 2008)
- 2007
- Mise à jour Programme de travail 112007
Mise à jour du programme de travail de la Pharmacopée Européenne (Décisions de la Commission Européenne de Pharmacopée, novembre 2007) - Modification Work Programme 112007
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, November 2007) - Modifications Work Programme 062007
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, June 2007) - Modifications Work Programme 0307
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, March 2007)
- Mise à jour Programme de travail 112007
- 2006
- Modification Work Programme 1106
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, November 2006) - Modification Work Programme 0606
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, June 2006) - Modification Work Programme 0306
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, March 2006)
- Modification Work Programme 1106
- 2005
- Modification Work Programme 1105
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, November 2005) - Modification Work Programme 0605
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the European Pharmacopoeia Commission, June 2005)
- Modification Work Programme 1105
- 2004
- 2003
- Biological Standardisation Programme
- General
- Potentialy genotoxic impurities & PhEur monographs
General Information, Pharmeuropa 20.3, July 2008 - Impuretés potentiellement génotoxiques & monographies
Information générale, Pharmeuropa 20.3, juillet 2008 - Policy Paper: Potentially genotoxic impurities, March 2008
PA/PH/SG (07) 52 COM 1R (English & French) - Procedure 4 Workflow
- Procédure 4 Processus
- Procedure 1 Workflow
- Procédure 1 Processus
- Règles de Déontologie relatives aux Travaux de la Pharmacopée Européenne
PA/PH/Exp. ROP/T (11) 8 DEF - Règlement intérieur de la Commission Européenne de Pharmacopée
PA/PH/SG (11) 53 COM DEF - Guide relatif aux travaux de la Pharmacopée européenne
PA/PH/SG (11) 54 DEF - 1994 Protocol PhEur (English)
- 1994 Protocole PhEur (Français)
- 050
- 1964 Convention Ph Eur (Français)
- Clé des Monographies
- List of Groups of Experts and Working Parties
- Procédure 1 Processus (mis à jour : juillet 2011)
Elaboration/Révision d\'une monographie (mis à jour : juillet 2011) - Procédure 4 Processus (mis à jour : juillet 2011)
Elaboration d\'une monographie (mis à jour : juillet 2011) - Request for revision of monograph or general chapter
- RCG Quality of raw materials
- Potentialy genotoxic impurities & PhEur monographs
- Enquiries
- Resolutions
- NOUVEAU : Résolution AP-CPH (12) 4 du Comité européen sur les produits et les soins pharmaceutiques
11 mai 2012 - NOUVEAU : Lettre circulaire pour Résolution AP-CPH (12) 4 du Comité européen sur les produits et les soins pharmaceutiques
- Résolution AP-CPH (12) 3 du Comité européen sur les produits et les soins pharmaceutiques
5 avril 2012 - Résolution AP-CPH (12) 2 du Comité européen sur les produits et les soins pharmaceutiques
5 avril 2012 - Résolution AP-CPH (12) 1 du Comité européen sur les produits et les soins pharmaceutiques
5 avril 2012 - Lettre circulaire pour résolutions AP-CPH(11) du Comité européen sur les produits et les soins pharmaceutiques
- Resolution AP-CPH (11) 8 du Comité européen sur les produits et les soins pharmaceutiques
4 janvier 2012 - Lettre circulaire pour Resolution AP-CPH (11) 7 du Comité européen sur les produits et les soins pharmaceutiques
- Resolution AP-CPH (11) 7 du Comité européen sur les produits et les soins pharmaceutiques
- Lettre circulaire pour Resolution AP-CPH (11) 7 du Comité européen sur les produits et les soins pharmaceutiques
- Résolution AP-CPH (11) 6 du Comité européen sur les produits et les soins pharmaceutiques
1 Septembre 2011 - Résolution AP-CPH (11) 5 du Comité européen sur les produits et les soins pharmaceutiques
Le 28 mai 2011
- NOUVEAU : Résolution AP-CPH (12) 4 du Comité européen sur les produits et les soins pharmaceutiques
- 3R
- BSP004_Somatropin_CRS
- BSP006_D_Vero
- BSP016_HepA_invitro
- BSP019_035_TD_serol
- BSP019_T_serol
- BSP021_IPV_bioassay
- BSP023_IPV_Ag_content
- BSP024_Vet_C_tetani_BRP
- BSP034_P1_Dserol
- BSP034_P1_Ext_Dserol
- BSP034_P2_Dserol
- BSP038_Vet_Erysipelas_serol_BRP
- BSP045_C_tetani_serol_BRP
- BSP055_Newcstle_serol_P1
- BSP055_Newcstle_serol_P2
- BSP076_P_toxin
- BSP079_T_Ig_invitro
- BSP083_aP_ serol
- BSP105_Vet Rabies_serol
- wP_serol_ECVAM
- Animal welfare progress in European Pharmacopoeia monographshttp://yourlooper.com/#
- Reduction, Replacement and Refinement of animal tests in the European Pharmacopoeia
- E Charton article new approaches
- NOUVEAU: L’immunoglobuline humaine normale pour administration par voie intraveineuse
- Pharmacopoeial Discussion Group (PDG)
- PDG Working Procedures
PDG Working Procedures (signed off document Nov. 2007) English only - PDG Statement IH Policy
PDG Statement of International Harmonisation Policy (November 2003) - GDP Énoncé de la politique d\'HI
Énoncé de la politique d\'harmonisation (novembre 2003) - Procédure de travail du GDP
Procédure de travail du Groupe de Discussion des Pharmacopées (GDP) (juin 2010) - GDP Etat des travaux
décembre 2011 - Calendrier prévisionnel décembre 2011
décembre 2011 - Achievements of the BSP
- BSP004_Somatropin_CRS
- BSP006_D_Vero
- BSP016_HepA_invitro
- BSP019_035_TD_serol
- BSP019_T_serol
- BSP021_IPV_bioassay
- BSP023_IPV_Ag_content
- BSP024_Vet_C_tetani_BRP
- BSP034_P1_Dserol
- BSP034_P1_Ext_Dserol
- BSP034_P2_Dserol
- BSP038_Vet_Erysipelas_serol_BRP
- BSP045_C_tetani_serol_BRP
- BSP055_Newcstle_serol_P1
- BSP055_Newcstle_serol_P2
- BSP076_P_toxin
- BSP079_T_Ig_invitro
- BSP083_aP_ serol
- BSP105_Vet Rabies_serol
- wP_serol_ECVAM
- PDG Working Procedures
- European Pharmacopoeia
- Certification EDQM HealthCare European Pharmacopoeia & PDG OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk Other
- Procedure of Certification
- CEP - Suspension or withdrawal of a CEP PA/PH/CEP (08) 17, R3
- PA/PH/CEP (10) 116 Exigences applicable aux notifications déclarées à la DEQM
- CEP - Guidance for electronic applications PA/PH/CEP (09) 108, 1R
- CEP - Procedures for CEP applications PA/PH/CEP (09) 109, 1R
- CEP - Guideline on revision/renewal of certificates of suitability to the monographs of the European Pharmacopoeia PA/PH/CEP (04) 2, 4R
- CEP - Procedures for management of revisions/renewals of certificates of suitability to the monographs of the European Pharmacopoeia PA/PH/Exp. CEP/T (04) 18, 2R
- CEP - Nouvelle procédure d’évaluation pour les dossiers frères PA/PH/CEP (09) 141
- CEP - Clarification on acceptability of CEP applications, PA/PH/CEP (08) 60
- CEP - Note for the applicants: procedure for validation of new applications PA/PH/Exp. CEP/T (08) 37
- CEP - PA/PH/Exp. CEP/T (08) 37 Note aux demandeurs : Procédure de validation des nouvelles demandes
- CEP Procedure Revised Version Resolution AP-CSP (07) 1
- CEP - PAPHExpCEPT0426: Revision of TSE Certificates for the 5th Edition of the European Pharmacopoeia (15/11/04)
- PA/PH/CEP (10) 85 Plus de changement accepté durant l’évaluation
- CEP - La position de la DEQM concernant les demandes de CEP pour les substances biologiques PA/PH/CEP (09) 152 rev 01
- PA/PH/CEP (10) 118 1R (FR)
PA/PH/CEP (10) 118 1R (FR) - PA/PH/CEP (11) 47 Clarification concernant l’évaluation des données de stabilité dans le cadre de la procédure de Certification
PA/PH/CEP (11) 47 - PA/PH/CEP (11) 48 Evaluation du conditionnement dans le cadre de la procédure de Certification
PA/PH/CEP (11) 48
- Application Forms and QOS Template
- Content of Dossier
- List of assessors
- General
- CEP Terms of Reference for Certif
- PA/PH/CEP (10) 86 Changement de contacts
- PA/PH/CEP (11) 18 FR
- CEP - Refus d’informations provenant de tierces parties, PA/PH/CEP (11) 18 (FR)
- PA/PH/CEP (11) 29
PA/PH/CEP (11) 29 - CEP - Note to the attention of all holders of TSE certificates of suitability, PA/PH/CEP (11) 33
- CEP - Communication with EDQM Certification Division, PA/PH/CEP (11) 70
- CEP-Programme de rationalisation des inspections BPF-PAPHCEP1230FR
- CEP Cas de falsification de données dans le cadre de la procédure CEP
- PAPHCEP_12_49_hook_fraud_on_CEP Français
- template letter
Linked to PA/PH/CEP (12) 49 - Monthly Report of Activities
- 2013
- 2012
- CEP monthly report January 2012
- CEP monthly report February 2012
- CEP monthly report March 2012
- CEP monthly report April 2012
- CEP monthly report May 2012
- CEP monthly report June 2012
- CEP monthly report July 2012
- CEP monthly report August 2012
- CEP monthly report September 2012
- CEP monthly report October 2012
- CEP monthly report November 2012
- CEP monthly report December 2012
- Registration fees
- Inspections
- Rapport du programme pilote international d’inspection des substances actives à usage pharmaceutique
Rapport du programme pilote international d’inspection des substances actives à usage pharmaceutique
- Rapport du programme pilote international d’inspection des substances actives à usage pharmaceutique
- Technical advice
- Samples
- Procedure of Certification
- OMCL Activities & Guidelines EDQM HealthCare European Pharmacopoeia & PDG Certification Publications, Products Events organised by the EDQM HelpDesk Other
- General European OMCL Network Activities
- General procedure for Sampling and Testing of Centrally-Authorised Products (PA/PH/CAP (05) 49 9R)
Updated 03/12/12 - Letter EDQM and HMA
HMA Working Group on Product Testing Document - Principles for Mutual Recognition of Control results
HMA Working Group on Product Testing Document (Version 1.0) - MRP/DCP Post-Marketing surveillance
Co-operation in post-marketing surveillance of Mutual Recognition /Decentralised Procedure Products (PA/PH/OMCL 06 116 11R, September 2012) - PA/PH/OMCL (07) 79 25R Terms of Reference
Terms of Reference for the General European OMCL Network (GEON) of the Council of Europe (PA/PH/OMCL (07) 79 25R) - PA/PH/OMCL (07) 89 8R - Annex 1 to the GEON Terms of Reference: Definition of an OMCL and OMCL Status within the GEON
- PA/PH/OMCL (07) 90 5R - Annex 2 to the GEON Terms of Reference: Factors for determining OMCL status within the GEON
- PA/PH/OMCL (09) 45 11R - Annex 3 List of GEON members
Updated 18/03/13 - PA/PH/OMCL (08) 04 16R - Annex 4 to the GEON Terms of Reference: Questionnaire to query the OMCL status of present and future members of the GEON
- NEW: GEON ToR_Annex5_OMCL 10 93 8R
- PA/PH/OMCL (09) 87 3R OMCL Network support for the implementation of the CoE MEDICRIME Convention
- Survey extraneous agents
- General Procedure for Sampling and Testing of Generic Centrally-Authorised Products” (PA/PH/CAP (12) 32 6R)
- General procedure for Sampling and Testing of Centrally-Authorised Products (PA/PH/CAP (05) 49 9R)
- Human Biologicals (OCABR)
- Change request for revision of adopted guidelines/procedures for batch release
- Guidelines
- Administrative procedures
- Procedure For Official Control Authority Batch Release of Centrally Authorised Immunological Medicinal Products For Human Use And Medicinal Products Derived From Human Blood And Plasma (2012)
June 2012 - REVISED: EU Administrative Procedure for Official Control Authority Batch Release 2012
June 2012 - Annex III: Human OCABR Contact list. Updated 21/05/13
- Procedure for Official Control Authority Batch Release of Centrally Authorised Immunological Medicinal Products for Human Use and Medicinal Products Derived From Human Blood and Plasma
- Procedure For Official Control Authority Batch Release of Centrally Authorised Immunological Medicinal Products For Human Use And Medicinal Products Derived From Human Blood And Plasma (2012)
- Guidelines for blood products
- REVISED: Clotting Factor Concentrates, Plasma Inhibitor Concentrates and Fibrin Sealants
- REVISED: Human albumin
- REVISED: Human immunoglobulin
- REVISED: Human Plasma (pooled & treated for virus inactivation) formerly Solvent-Detergent (SD) Plasma
- Official Control Authority Protocol for Approval of Plasma pools
- Guidelines for vaccines
- REVISED: BCG Vaccine
- Cell Cultured Influenza Vaccine (Surface Antigen, Inactivated) NEW GUIDELINE
- REVISED: Cholera vaccine (Oral, Inactivated)
- REVISED: Diphtheria and Tetanus vaccine (Absorbed)
- REVISED: Diphtheria, Tetanus and Hepatitis B (rDNA) Combined vaccine (Adsorbed)
- REVISED: Diphtheria, Tetanus and Pertussis (Acellular component) Combined Vaccine (adsorbed)
- REVISED: Diphtheria, Tetanus and Pertussis (Whole cell) Combined vaccine (Adsorbed)
December 2011 - REVISED: Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Acellular component) and Haemophilus Type B Conjugate Combined vaccine (Adsorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Acellular component) and Hepatitis B (rDNA) Combined vaccine (Adsorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Acellular component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined vaccine (Adsorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Acellular component), Poliomyelitis (Inactivated) Combined vaccine (Adsorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) and Haemophilus Type B Conjugate Combined Vaccine (Absorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Acellular component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) with separate Haemophilus Type B Conjugate Combined vaccine (Absorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Whole cell) and Poliomyelitis (Inactivated) Combined vaccine (adsorbed)
- REVISED: Diphtheria, Tetanus, Pertussis (Whole cell), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined vaccine (Adsorbed)
- REVISED: Haemophilus Type B Conjugate and Hepatitis B (rDNA) Combined Vaccine
- Haemophilus Type B Conjugate and Meningococcal C Conjugate Combined Vaccine
- REVISED: Haemophilus Type B Conjugate Vaccine
- REVISED: Hepatitis A (Inactivated) and Hepatitis B (rDNA) Combined Vaccine (Absorbed)
- REVISED: Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed)
- REVISED: Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Absorbed) for Mix-At-Use Format Products
- REVISED: Hepatitis A Vaccine (Inactivated, Absorbed)
- REVISED: Hepatitis A (Virosomal) Vaccine
- REVISED: Hepatitis B (rDNA) Vaccine
- REVISED: Human Papillomavirus (rDNA) Vaccine
- REVISED: Influenza Vaccine
- Influenza Vaccine (Surface Antigen, Inactivated, Virosome)
- REVISED: Japanese Encephalitis (JE) Vaccine, Inactivated
- REVISED: Live Attenuated Influenza Vaccine produced on eggs
- REVISED: Measles, Mumps, and/or Rubella Component Combined Vaccine
- REVISED: Measles, Mumps, Rubella & Varicella Combined vaccine
- REVISED: Measles Vaccine
- REVISED: Meningococcal Polysaccharide Vaccine
- REVISED: Monovalent or multivalent meningococcal polysaccharide conjugate vaccine
- REVISED: Multivalent Pneumococcal Polysaccharide Conjugate Vaccine
- REVISED: Mumps Vaccine
- Pandemic Influenza vaccine REVISED
Pandemic Influenza Vaccine (2009) - REVISED: Pertussis Vaccine (Acellular Component, adsorbed)
- REVISED: Pneumococcal Polysaccharide Vaccine
- REVISED:Poliomyelitis Vaccine (Inactivated)
- REVISED: Poliomyelitis Vaccine (Oral) (OPV) - Monovalent Bulk
- REVISED: Poliomyelitis Vaccine (Oral) (OPV) - Trivalent Vaccine
- REVISED: Rabies vaccine
- REVISED: Rotavirus Vaccine
- REVISED: Rubella Vaccine
- REVISED: Tick-Borne Encephalitis (TBE) Vaccine
- REVISED: Typhoid Polysaccharide Vaccine
- REVISED: Typhoid Vaccine (Live-Strain type 21a Oral)
- REVISED: Vaccine containing Vaccinia virus produced in cell culture (Smallpox vaccine)
- REVISED: Varicella Vaccine & Shingles Vaccine
- REVISED: Yellow Fever Vaccine
- Other related procedures
- OCABR Human Biologicals Decision Flowchart
- Human Biologicals Flowchart
OCABR Human Biologicals Flowchart (revised December 2010)
- Human Biologicals Flowchart
- Veterinary Biologicals (OCABR/OBPR)
- NEW: Marketing Information Form
- REV vet prefacenote_07 1341w FR
- All guidelines OCABR Vet
- Procedures
- Procedure-Article 82
- Procedure-Article 81
- Annex IV - OMCL/CA liste de contacts
(updated 02/04/13)
- Model Protocols for Manufacturers
- Product Specific Technical Guidelines
- UPDATED: Aujeszky\'s Disease Vaccine (inactivated)
- UPDATED: Aujeszky\'s Disease Vaccine (live)
- UPDATED: Brucellin Preparations
- UPDATED: Brucellosis Vaccine (live)
- UPDATED: Equine Influenza Vaccine (inactivated)
- UPDATED: Infectious Bovine Rhinotracheitis Vaccine (inactivated)
- UPDATED: Infectious Bovine Rhinotracheitis Vaccine (live)
- UPDATED: Newcastle Disease Vaccine (inactivated)
- UPDATED: Newcastle Disease Vaccine (live)
- UPDATED: Purified protein derivative (PPD), bovine
- UPDATED: Rabies Vaccine (inactivated) for veterinary use
- UPDATED: Rabies Vaccine for Foxes (live)
- UPDATED: Swine Erysipelas Vaccine (inactivated)
- UPDATED: Swine Erysipelas Vaccine (live)
- UPDATED: Tuberculin purified protein derivative (PPD), avian
- Tuberculin Purified Protein Derivative (PPD), Bovine
- IVMP Decision Flowchart
- IVMP_Flowchart
Decision Flowchart for CA for the Control of IVMPs
- IVMP_Flowchart
- Quality Assurance for the OMCL Network
- Documents
- Scope of Accreditation of Official Medicines Control Laboratories
PA/PA OMCL (05) 48 DEF CORR (December 2007) - Validation of Analytical Procedures
PA/PH/OMCL (05) 47 DEF (June 2005) - Uncertainty of Measurements - Part I (Compliance testing)
PA/PA/OMCL (05) 49 DEF CORR (December 2007) - Uncertainty of Measurements - Part II (Other than compliance testing)
PA/PH/OMCL (07) 106 DEF (December 2007) - Standard Aide-Mémoire for the Mutual Joint Audit of OMCLs
PA/PH/OMCL (06) 72 2R (FORM/158-Rev.02) (February 2011) - Aide-Memoire for environmental conditions & treatment of biological models
PA/PH/OMCL (07) 75 2R (Form/159-Rev. 2) (January 2011) - Evaluation & Reporting of Results
PA/PH/OMCL (07) 28 DEF CORR (December 2007) - UPDATED: Qualification of Equipment (core document)
PA/PH/OMCL (08) 73 2R (July 2011) - UPDATED: Annex 1: Qualification of HPLC Equipment
PA/PH/OMCL (11) 04 (July 2011) - Annex 2: Qualification of GC equipment
PA/PH/OMCL (06) 86 DEF (October 2006) - Annex 3: Qualification of UV-Visible spectrophotometers
PA/PH/OMCL (07) 11 DEF CORR (December 2007) - Annex 4: Qualification of IR spectrophotometers
PA/PH/OMCL (07) 12 DEF CORR (December 2007) - UPDATED: Annex 5 Qualification of Automatic Titrators
Updated 17/04/12 - Annex 6: Qualification of piston pipettes
PA/PH/OMCL (09) 64 2R, Annex 6: Qualification of piston pipettes (July 2010) - NEW: Annex 7 Qualification of mass spectrometers
PA/PH/OMCL (10) 86 2R (July 2011) - Validation of Computerised Systems - Core Document
PA/PH/OMCL (08) 69 3R (July 2009) - Annex 1: Validation of computerised calculation systems: example of validation of in-house software
PA/PH/OMCL (08) 87 2R Validation of Computerised Systems (July 2009) - Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN)
PA/PH/OMCL (08) 88 R Validation of Computerised Systems (July 2009) - Annex 3: Validation of computers as part of test equipment
PA/PH/OMCL (08) 89 R Validation of Computerised Systems (July 2009) - Archiving within the OMCL Network
PA/PH/OMCL (07) 105 DEF (April 2001) - Management of Reagents
PA/PH/OMCL (11) 157 5R - Handling and Use of Reference Standards in the OMCL Network
- Scope of Accreditation of Official Medicines Control Laboratories
- Documents
- Proficiency Testing Scheme (PTS)
- Quality Monitoring of Stockpiled Medicines
- Monitoring of Stockpiled Medicines – Development of Technical Guidelines
Technical Guudeline - PA/PH/OMCL (09) 94 8R - NEW: Stockpiling of Medicines – Monitoring – General Considerations
Position Paper - PA/PH/OMCL (09) 05 R
- Monitoring of Stockpiled Medicines – Development of Technical Guidelines
- 7- Testing of counterfeit / illegal medicines within the GEON
- General European OMCL Network Activities
- Publications, Products EDQM HealthCare European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Events organised by the EDQM HelpDesk Other
- Publications Catalogue
- Catalogue 2013 EDQM Web
- Comment commander une publication de la DEQM
- How do I use the EDQM Online Store?
- Publications de la DEQM Expédition & livraison
- How do I pay EDQM invoices?
- Comment adresser une réclamation au sujet d\'une commande de la DEQM
- Distributors List India (January 2010)
- Delivery charges PTS
- How to order proficiency Testing Scheme Studies
- 8th Edition
- 8th Edition initial volumes 8.0
- 8th Edition implementation dates and texts deleted
- Résolution AP-CPH (13) 1 Adoptée par le Comité européen sur les produits et les soins pharmaceutiques (CD-P-PH) (Accord Partiel)
- Résolution AP-CPH (13) 2 Adoptée par le Comité européen sur les produits et les soins pharmaceutiques (CD-P-PH) (Accord Partiel)
- Résolution AP-CPH (13) 3 Adoptée par le Comité européen sur les produits et les soins pharmaceutiques (CD-P-PH) (Accord Partiel)
- Lettre circulaire concernant les Résolutions AP-CPH (13) 1-2-3
- 7th Edition
- A list of converted monographs 7th Edition
A list of converted monographs for the 6th Edition - Caractéristiques techniques - Clé USB & Version en ligne
- 7th Edition Supplement 7.8
- 7th Edition Supplement 7.7
- 7th Edition Supplement 7.6
- 7th Edition Supplement 7.5
- 7th Edition Supplement 7.4
- 7th Edition Supplement 7.3
- 7th Edition Supplement 7.2
- 7th Edition Supplement 7.1
- 7th Edition initial volumes 7.0
- 7th Edition implementation dates and texts deleted
- Lettre Circulaire PhEur Commission, 19 avril 2010
- AP-CDP (10) 1 Suppression de la monographie, 15 mars 2010
- Circular Letter PhEur Commission, 27 March 2009
- Lettre Circulaire PhEur Commission, 27 mars 2009
- AP-CPH (09) 3 7th Edition Mise en application
- AP-CPH (09) 3 7th Edition Date of implementation
- Lettre Circulaire PhEur Commission, 19 avril 2010
- AP-CPH (10) 2 Supplement 7.1 Mise en application
- AP-CPH (10) 3 Supplement 7.2 Mise en application
- AP-CPH (10) 4 Supplement 7.3 Mise en application
- Circular Letter PhEur Commission, 19 April 2010
- AP-CPH (10) 5 Héparine sodique (333) et Héparine calcique (332) Mise en application
- A list of converted monographs 7th Edition
- 6th Edition
- List of Converted Monographs
A list of converted monographs for the 6th Edition - How to Read a Monograph
- 6th Edition Supplement 6.8
- 6th Edition Supplement 6.7
- 6th Edition Supplement 6.6
- 6th Edition Supplement 6.5
- 6th Edition Supplement 6.4
- 6th Edition Supplement 6.3
- 6th Edition Supplement 6.2
- 6th Edition Supplement 6.1
- 6th Edition initial volumes 6.0
- 6th Edition implementation dates and texts deleted
- Lettre Circulaire Résolution AP-CPH (09) 4 (French)
- Circular Letter Resolution AP-CPH (09) 4 (English)
- 6th Edition Implementation Dates: AP-CSP (06) 04
- AP-CPH (07) 3 Supplement 6.1 Date of implementation
- AP-CPH (07) 3 Supplement 6.1 Mise en application
- AP-CPH (07) 4 Supplement 6.2 Date of implementation
- AP-CPH (07) 4 Supplement 6.2 Mise en application
- AP-CPH (07) 5 Supplement 6.3 Mise en application
- AP-CPH (07) 5 Supplement 6.3 Date of implementation
- AP-CPH (08) 1 Supplement 6.4 Date of implementation
- AP-CPH (08) 1 Supplement 6.4 Mise en application
- AP-CPH (08) 2 Supplement 6.5 Date of implementation
- AP-CPH (08) 2 Supplement 6.5 Mise en application
- AP-CPH (08) 3 Supplement 6.6 Date of implementation
- AP-CPH (08) 3 Supplement 6.6 Mise en application
- AP-CPH (08) 5 European Committee on Pharmaceuticals & Pharmaceutical Care
Adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) (Partial Agreement) on 18 July 2008 - AP-CPH (08) 5 Comité européen sur les produits et les soins pharmaceutiques
Adoptée par le Comité européen sur les produits et les soins pharmaceutiques (CD-P-PH) (Accord Partiel) le 18 juillet 2008 - AP-CPH (09) 1 Supplement 6.7 Date of implementation
- AP-CPH (09) 1 Supplement 6.7 Mise en application
- AP-CPH (09) 2 Supplement 6.8 Date of implementation
- AP-CPH (09) 2 Supplement 6.8 Mise en application
- List of Converted Monographs
- 5th Edition
- 5th Edition Supplement 5.8
- E Comments Supplement 5.8
Comments concerning some revised/corrected texts published in Supplement 5.8 - E Contents List 5.8
English List of Contents Supplement 5.8 - F Contents List 5.8
French List of Contents Supplement 5.8 - E Index 5th 5.8
English Cumulative Index 5th Edition 5.8 - F Index 5th 5.8
French Cumulative Index 5th Edition 5.8
- E Comments Supplement 5.8
- 5th Edition Supplement 5.7
- E Comments Supplement 5.7
Comments concerning some revised/corrected texts published in Supplement 5.7 - E Index 5th 5.7
English Cumulative Index 5th Edition 5.7 - F Index 5th 5.7
French Cumulative Index 5th Edition 5.7 - E Contents List 5.7
English List of Contents Supplement 5.7 - F Contents List 5.7
French List of Contents Supplement 5.7
- E Comments Supplement 5.7
- 5th Edition Supplement 5.6
- E Comments Supplement 5.6
Comments concerning some revised/corrected texts published in Supplement 5.6 - E Index 5th 5.6
English Cumulative Index 5th Edition 5.6 - F Index 5th 5.6
French Cumulative Index 5th Edition 5.6 - E Contents List 5.6
English List of Contents Supplement 5.6 - F Contents List 5.6
French List of Contents Supplement 5.6
- E Comments Supplement 5.6
- 5th Edition Supplement 5.5
- E Comments Supplement 5.5
Comments concerning some revised/corrected texts published in Supplement 5.5 - E Index 5th 5.5
English Cumulative Index 5th Edition 5.5 - F Index 5th 5.5
French Cumulative Index 5th Edition 5.5 - E Contents List 5.5
English List of Contents Supplement 5.5 - F Contents List 5.5
French List of Contents Supplement 5.5
- E Comments Supplement 5.5
- 5th Edition Supplement 5.4
- E Comments Supplement 5.4
Comments concerning some revised/corrected texts published in Supplement 5.4 - E List New Reagents
List of new reagents: Supplement 5.4 - F Index 5th 5.4
French Cumulative Index 5th Edition 5.4 - E Index 5th 5.4
English Cumulative Index 5th Edition 5.4 - E Contents List 5.4
English List of Contents Supplement 5.4 - F Contents List 5.4
French List of Contents Supplement 5.4
- E Comments Supplement 5.4
- 5th Edition Supplement 5.3
- E Comments Supplement 5.3
Comments concerning some revised/corrected texts published in Supplement 5.3 - E Index 5th 5.3
English Cumulative Index 5th Edition 5.3 - F Index 5th 5.3
French Cumulative 5th Edition 5.3 - E Contents List 5.3
English List of Contents Supplement 5.3 - F Contents List 5.3
French List of Contents Supplement 5.3
- E Comments Supplement 5.3
- 5th Edition Supplement 5.2
- E Comments Supplement 5.2
Comments concerning some revised/corrected texts published in Supplement 5.2 - E Index 5th 5.2
English Cumulative Index 5th Edition 5.2 - F Index 5th 5.2
French Cumulative Index 5th Edition 5.2 - E Contents List 5.2
English List of Contents Supplement 5.2 - F Contents List 5.2
French List of Contents Supplement 5.2
- E Comments Supplement 5.2
- 5th Edition Supplement 5.1
- E Comments Supplement 5.1
Comments concerning some revised/corrected texts published in Supplement 5.1 - E Contents list 5.1
English List of Contents Supplement 5.1 - F Contents List 5.1
French List of Contents Supplement 5.1
- E Comments Supplement 5.1
- 5th Edition initial volumes 5.0
- E Comments 5th Edition
Comments concerning some revised/corrected texts published in the 5th Edition - E Contents List 5th
English List of Contents 5th Edition - F Contents List 5th
French List of Contents 5th Edition
- E Comments 5th Edition
- 5th Edition implementation dates and texts deleted
- APCSP0603E
Supplement 5.8 date of implementation = AP-CSP (06) 3 - APCSP0602E
Supplement 5.7 date of implementation = AP-CSP (06) 2 - APCSP0601E
Suppression Method of Analysis (2.9.13) = AP/CSP (06) 1 - APCSP0504E
Suppression Monograph Glucagon (0612) = AP/CSP (05) 4 - APCSP0503E
Supplement 5.6 date of implementation = AP-CSP (05) 3 - APCSP0502E
Supplement 5.5 date of implementation = AP-CSP (05) 2 - APCSP0501E
Supplement 5.4 date of implementation = AP-CSP (05) 1 - APCSP0404E
List of monographs deleted = AP/CSP (04) 4 - APCSP0403E
Supplement 5.3 date of implementation = AP/CSP (04) 03 - APCSP0402E
Supplement 5.2 date of implementation = AP/CSP (04) 2 - APCSP0401E
Supplement 5.1 date of implementation = AP/CSP (04) 1 - APCSP0304E
List of monographs deleted = AP/CSP (03)4
- APCSP0303E
5th Edition date of implementation = AP/CSP (03)03
- APCSP0603E
- 5th Edition Supplement 5.8
- 4th Edition
- 4th Edition: Comments concerning revised texts
- E comments revised texts Suppl 4.8
English comments concerning some revised texts Supplement 4.8 - E comments revised texts Suppl 4.7
English comments concerning some revised texts Supplement 4.7 - List revised texts 4th Edition 4.0
Revised texts published in the 4th Edition - E comments revised texts Suppl 4.6
English comments concerning some revised texts Supplement 4.6 - E comments revised texts Suppl 4.5
English comments concerning some revised texts Supplement 4.5 - E comments revised texts Suppl 4.4
English comments concerning some revised texts Supplement 4.4 - E List revised texts Suppl 4.3
English comments concerning some revised texts Supplement 4.3 - E List revised texts Suppl 4.2
Revised texts published in Supplement 4.2 - E List revised texts Suppl 4.1
Revised texts published in Supplement 4.1
- E comments revised texts Suppl 4.8
- Texts revised/corrected with rapid implementation
- 4th Edition: Comments concerning revised texts
- Electronic publications
- General Terms & Conditions
- CGL-EP Enligne
Termes & Conditions générales de l\'accord de license relatif à l\'accès à la Pharmacopée en ligne (Aout 2005) - Certificate-GTC-EP Online
- GTC-EP Online
General Terms & Conditions of the license agreement for Online access to the European Pharmacopoeia Online Service (August 05)
- CGL-EP Enligne
- Handbook
- General Terms & Conditions
- Pharmaceutical Care
- List of Standard Terms
- General
- Introduction & Guidance for Use
Introduction and guidance for use (November 2010) - Termes de Reference Formulaire
FORMULAIRE de DEMANDE d’ADDITION ou de MODIFICATION de TERME DE RÉFÉRENCE / TERME COMBINÉ à la liste des TERMES DE RÉFÉRENCE
- Introduction & Guidance for Use
- General
- ICH Guidelines Residual Solvents
- Technical Guides
- Structure Nomenclature
- Elaboration of Monographs
- NOUVEAU: Guide technique pour l’élaboration et l’utilisation des monographies relatives aux produits dérivés du plasma humain
- Guide technique pour l’élaboration des monographies 5eme Edition
- Guide technique pour l’élaboration des monographies de peptides synthétiques et protéines recombinantes
- Guide technique pour l’élaboration des monographies de préparations radiopharmaceutiques
- Guide pour l’élaboration des monographies de vaccins pour usage vétérinaire
- Guide technique pour l’élaboration des monographies de vaccins et autres médicaments immunologiques humains
- Technical Guide for the elaboration of monographs on vaccines and other immunological human medicinal products
- Guide Technique pour l\'élaboration des monographies relatives aux huiles grasses et leurs dérivés (2007)
- Technical Guide for the Elaboration of Monographs on Fatty oils and Derivatives (2007)
- Guide pour l\'élaboration des monographies de drogues végétales et préparations à la base de drogues végétales (2007)
- Technical Guide for the Elaboration of Monographs on herbal drugs and herbal drug preparations (2007)
- Guide Technique pour l\'Élaboration de Monographies, 4ème Edition
- Technical Guide for the Elaboration of Monographs 4th Edition
- Guide technique pour l\'élaboration et l\'utilisation des monographies de vaccines et medicaments immunologiques a usage veterinaire
- Technical Guide for the Elaboration of Monographs on Synthetic Peptides & Recombinant DNA Proteins, 1st Edition, 2006
- Guide Technique pour l\'Elaboration des Monographies de Peptides Synthétiques & Protéines ADN Recombinants, 1ère Edition
- Guide Technique pour l\'élaboration des Monographies - 6ème édition 2011
- European Pharmacopoeia Style Guide
- European Pharmacopoeia Style Guide, December 2006
- European Pharmacopoeia Style Guide, July 2011
Europen Pharmacopoeia Style Guide, July 2011
- Proceedings of international conferences
- List of Contents: 3rd Conference on Certification (Athens, 8-9 November 2001)
- List of Contents: International Harmonisation of General Monographs on Dosage Form and Pharmacotechnical Test Methods (Sevilla, 1998)
- List of Contents: Alternatives to Animal Challenge Tests in the Batch Control of Leptospira Vaccines for Veterinary Use
- List of Contents: Biologicals Beyond 2000
- List of Contents: Tetanus Vaccines for Human Use
- List of Contents: Mycoplasma testing
- List of Contents: Herbal Medicinal Products
- List of Contents: Future Face of the European Pharmacopoeia (September 2001)
- Ph.Eur. Reference Standards
- Reference Standards - Dispatch & delivery
- 2010 Nouvelles Conditions d\'Expedition
- Déclaration d’usage final pour les Précurseurs Chimiques de Drogues
- 2010 Shipping Information for Reference Standards
- Delivery Times
- Comment commander des étalons de reference
- Letter Replacing Cert. of Analysis
- Lettre Remplacant le Cert. d\'Analyses
- Cadre Judiciaire & Statut Diplomatique des Standards de Référence pour les Douanes
- Legal Framework and Diplomatic Status of Reference Standards for Customs Purposes
- CRS Terms of Supply (November 2008)
- CRS Conditions Générales (novembre 2008)
- Hong Kong Customers - Additional form to complete and to accompany each CRS order
- Chinese Customers - Additional form to complete and to accompany each CRS order
- US Customers - Additional form to complete and to accompany each CRS order
- Declaration End User for Drug Precursors
- Brazilian Customers - Additional form to complete and to accompany each CRS order
- Declaration End User for Drug precursors
- Videos Ph. Eur. Reference Standards
- WHO ISA Reference Standards
- WHO ISA Reference Standard Order Form - pdf format
- WHO ISA Reference Standard Order Form - Word format
- Chinese Customers - Additional form to complete and to accompany each order.
- Hong Kong Customers - Additional form to complete and to accompany each order.
- US Customers - Additional form to complete and to accompany each order.
- Brazilian Customers - Additional form to complete and to accompany each ISA order
- ISA Catalogue Introduction
WHO ISA Catalogue - Introduction only (May 2006) - WHO ISA General Information
- WHO ISA General Procedure
- WHO ICRS Reference Substances
- CombiStats
- Blood Transfusion Guide
- Organ Transplantation Guide
- Cosmetics Guides
- Proficiency Testing Scheme
- Publications Catalogue
- Events organised by the EDQM EDQM HealthCare European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Publications, Products HelpDesk Other
- How to order Events
- Conditions Générales d\'Inscription aux Evenements
- Webinar: A Participant’s Guide on What to Expect
- European Pharmacopoeia Training Sessions 2013
- Fairs and Exhibitions
- Follow up previous events
- 2013
- 2012
- Reference Standards Symposium, 3-4 September 2012
- Programme
- Presentations
- Session 1: Regulatory aspects (Part 1)
- Session 1: Regulatory Aspects (Part 2)
- Session 2a: Biologicals
- Session 2b: Addressing the challenges in the characterisation of small molecules
- Session 3: Material Management / Technology Changes (Part 1)
- Session 3: Material Management / Technology Changes (Part 2)
- Closing Session
- Abstracts
- Posters
- Conference on Combatting Falsified Medical Products, 16 May 2012, Denmark
- Copenhagen__press.FR
- Programme
- Media Alert
- Conclusions
- Abstracts
- Presentations
- Certification Conference, 22-23 March 2012, Cyprus
- Workshop Aternatives to Leptospirosis Batch Potency Test
- Batch Release for Medicinal Products, 10-11 May 2012
- Blood supply management Symposium, 1 October 2012
- Reference Standards Symposium, 3-4 September 2012
- 2011
- Standardisation and Control of Allergen Preparations, 24 November 2011
- Programme
- Programme symposium 24 novembre 2011
Programme symposium 24 novembre 2011
- Programme symposium 24 novembre 2011
- Programme
- Medicrime Convention, Moscow, 26-27 October 2011
- Alternatives to Animal Testing, 8-9 September 2011
- 1 Programme
- Programme du Symposium
Programme du Symposium
- Programme du Symposium
- 2 Presentations
- 3 Posters
- 1 Programme
- APIB, Madrid, Spain, 14-17 June 2011
- Expert Workshop: Water for Injections, 24 March 2011
- Summary Report
- Atelier d\'experts, 24 mars 2011
L\'eau pour préparations injectables : utilisation possible de systèmes membranaires pour la production
- Atelier d\'experts, 24 mars 2011
- Summary Report
- Standardisation and Control of Allergen Preparations, 24 November 2011
- 2010
- Expert Workshop Pharmaceutical Care, 10 December 2010
- Proceedings
- Expert Workshop 10th December 2010
Indicators of the quality of pharmaceutical care
- Expert Workshop 10th December 2010
- Proceedings
- Expert Workshop: Impact of TCM on pharmaceutical practices, 28 October 2010
- Proceedings
- Proceedings Expert Workshop, 28th October 2010
Impact of traditional Chinese medicine on pharmaceutical practices in Europe
- Proceedings Expert Workshop, 28th October 2010
- Proceedings
- International Conference Quality of Medicines in a Globalised World: Dreams and Reality, 14-15 October 2010, Prague, Czech Republic
- Programme
- Presentations
- Plenary Session Thursday, 14 October 2010
- Workshop 1: Characterisation of biological molecules
- Workshop 2: New technologies and their impact on the Pharmacopoeia
- Workshop 3: Control of impurities: A challenge for all stakeholders
- Workshop 4: Application of 3R principles in a globalised world: dream or reality
- Workshop 5: The PhEur - Is it prepared for the future?
- Plenary Session Friday, 15 October 2010
- Proceedings
- Posters
- Symposium on Implementation of Pathogen Reduction Technologies For Blood Components, Strasbourg, France, 2-3 September 2010
- International Conference on counterfeit medical products, 15-16 April 2010, Basel, Switzerland
- EDQM Symposium, South Africa, 12-13 April 2010
- Training Session on the Guide for the elaboration and use of monographs on IVMPs, 18-19 March 2010
- Expert Workshop Pharmaceutical Care, 10 December 2010
- 2009
- CombiStats Training, 19-20 November 2009
- Expert Workshop: 19 November 2009
- Proceedings
- Proceedings Expert Workshop 19 November 2009
Assessing the quality of patient-centred pharmaceutical care in Europe
- Proceedings Expert Workshop 19 November 2009
- Proceedings
- Batch release for human vaccines, 15-16 October 2009
- 2009 Organ Donation Congress, 4-7 October 2009
- 2009 European Organ Donation Day Congress Programme
4-7 October Berlin (Germany)
- 2009 European Organ Donation Day Congress Programme
- Herbal drugs and herbal drug preparations, 25 September 2009
- PharmSciFair, Nice, France, 8-12 June 2009
- EDQM symposium - Final Programme, 9 June 2009
Sourcing of Active Pharmaceutical Ingredients (APIs)
- EDQM symposium - Final Programme, 9 June 2009
- API from Bioprocesses, APIB 2009, 3-6 June 2009
- Optimal Clinical Use of Blood Components, Wildbad Kreuth, Germany, 24-25 April 2009
- Expofarma Interphex, Mexico City, Mexico, 22-24 April 2009
- ISBT Regional Congress, Cairo, Egypt, 21-25 March 2009
- Expert Workshop, 24th September 2009
- Proceedings
- Proceedings Expert Workshop, 24th September 2009
Promoting standards for the quality and safety assurance of pharmacy-prepared medicinal products
- Proceedings Expert Workshop, 24th September 2009
- Proceedings
- 2008
- Regulatory submission procedures in EU, 13-14 November
- European Organ Donation and Transplantation Day, 18 October
- Presentations
- The Results and Possibilities Of Modern Treatment With Transplantation - Ferdinand Mülhbacher
- Equitable Access to Transplantation - Axel Rahmel
- Eurocet - Dr Alessandro Nanni Cota
- Heart Transplantation, Stem Cell Therapy and Mechanical Circulatory Support
- Global Overview on Donation - Beatriz Domiguez-Gil
- Personal Reflection and Public Debate on Organ Donation: A Teaching aid from the Council of Europe - Tina Garani-Papadatos
- Ethical Questions related to Donation - Guenter Kirste
- Council of Europe Actions and Activities in Organ Donation - Per Pfeffer
- Project: The Celebration of 10th European Donation Day
- Programme
- Presentations
- Pharmaceutical Reference Standards, 9-10 October
- Workshop on the Characterisation of Heparin Products, 19-20 June
- Summary of Workshop Sessions
- Speakers\' Biographical Notes
- Programme
- Presentations
- Session 1: Contamination of heparin - Part 1
Data from the field - market surveillance - batch results
Reaction from the licencing authorities - Session 1: Contamination of heparin - Part 2
Possible solutions for the future - view points from industry and academia - Session 1: Contamination of heparin - Part 3
Pharmacopoeias - plans for revision - Session 2: Global harmonisation - Part 1
Characterisation of UFH samples from the past decade
Physio-chemical characterisation - Session 2: Global harmonisation - Part 2
Characterisation of UFH samples from the past decade
Physico-chemical characterisation - Session 2: Global harmonisation - Part 3
Harmonisation of methods for estimation of potency - Session 3: Low molecular weight heparin
Unfractionated heparin as starting material for LMW heparins
Characterisation of LMW heparins
- Session 1: Contamination of heparin - Part 1
- Alternatives to animal testing, 23-24 April
- Programme
- Proceedings
- Presentations
- Session 1: Current regulations & review of progress
Session 1: Current regulations on alternatives and review of progress, 23 April - Session 2: Human Vaccines
Session 2: Human Vaccines - Safety and Potency, 23 April - Session 3: Veterinary Vaccines
Session 3: Veterinary Vaccines, 23 April - Session 4: Biotherapeutics
Session 4: Biotherapeutics, 24 April - Session 5: New Technologies
Session 5: New Technologies, 24 April - Session 6: Case Studies & Validation studies
Session 6: Case studies and validation studies, 24 April - Drawbacks of 3Rs implementation
Preliminary Feedback from an EDQM survey: an overview of the effective transposition of the 3Rs progress implemented in the Ph. Eur. monographs, and to identify and address causes for non-transposition or non-use in control activities
- Session 1: Current regulations & review of progress
- Posters
- 2007
- Working across disciplines and borders, 6-7 December
- Programme
- Background Documents
- 2007 Survey
2007 Survey on training needs and competencies of member states as regards combating counterfeit medicines and other forms of pharmaceutical crimes - Introduction
- 2007 Survey
- CPhI Worldwide 2007, Milan, 2-4 October
- European Co-operation and Synergy in Quality Stadards, 15-16 June
- Programme
- Prog Final 15-16
Final Programme - European co-operation & synergy in quality standards beyond the European Pharmacopoeia, 15-16 June 2007, Strasbourg, France
- Prog Final 15-16
- Proceedings
- Presentations
- Session 2: Licensing
Session 2: Licensing, 15 June 2007 - Session 1: General Introduction
Session 1: General Introduction, 15 June 2007 - Session 3: National Experiences of Formularies
Session 3: National Experiences of Formularies, 16 June 2007 - Session 4: Radiopharmaceuticals
Session 4: The specific case of radiopharmaceuticals manufactured extemporaneously in hospital radiopharmacies, 16 June 2007
- Session 2: Licensing
- Posters
- Symposium Poster Session
Poster Session, 15-16 June 2007
- Symposium Poster Session
- Programme
- New Frontiers in the Quality of Medicines, 13-15 June
- Programme
- Final Prog New Frontiers
Final Programme - New Frontiers in the Quality of Medicines, 13-15 June 2007, Strasbourg, France - Workshops & One-to-One Revised
Final Workshop & One-to-One Programme, 14 June 2006 - REVISED
- Final Prog New Frontiers
- Proceedings
- Presentations
- Plenary Sessions 13th & 15th June
- Plenary Session 13 June - Part 2
Plenary Session - Perspectives for co-operation: Partnership with the Regulatory Authorities & the PDG Pharmacopoeias, 13th June 2007 (Part 2) - Plenary Session 13 June - Part 1
Plenary Session - International Co-operation & Synergy in Quality Standards: Vision from Europe, 13th June 2007 (Part 1) - Plenary Session 13 June - Part 3
Plenary Session - Perspectives for co-operation: Partnership with Industry, 13th June 2007 (Part 3) - Plenary Session 15 June Part 2
Plenary Session - Action plan for the future: Recommendations from the Industry, 15th June 2007 (Part 2) - Plenary Session 15 June Part 1
Plenary Session - Action plan for the future: Recommendations from the Industry, 15th June 2007 (Part 1) - Russian Health and Pharmaceutical Authorities, The Russian Federation
Mr Nicolay Yurgel, Ministry of Healthcare and Social Development, 13th June 2007
- Plenary Session 13 June - Part 2
- Workshop Sessions 14th June
- PDG and the ICH Q4B
Workshop - Pharmacopoeial Discussion Group & the ICH Q4B - Updating monographs & methods (Part 1)
Workshop - Updating monographs and methods (Part 1) - Excipients: FRC & ICH Q8
Workshop - Excipients: Functionality related tests (FRC) & ICH Q8 - Herbals: Implementation of the new legislative framework
Workshop - Herbals: Implementation of the new legislative framework - New challenges for Pharmacopoeias
Workshop - New challenges for Pharmacopoeias - Herbals: Traditional Chinese medicines
Workshop - Herbals: Traditional Chinese Medicines - Quality standards for biologicals
Workshop - Quality standards for biologicals - Building a partnership for investigation of counterfeit medicines
Workshop - Building a partnership for the investigation of counterfeit medicines - International harmonisation: Microbiological techniques
Workshop - International harmonisation: Microbiological techniques - European Biological Standardisation Programme
Workshop - European Biological Standardisation Programmme - Reference standards
Workshop - Reference Standards: How to characterise them, key elements and qualification - Certification: How to use a CEP
Workshop - Certification: How to use a Certificate - Certification: Inspections
Workshop - Certification: Inspections - Homoeopathy
Workshop - Homoeopathy - Partnership developed within the OMCLs
Workshop - Partnership developed within the Official Medicines Control Laboratories (OMCLs) - Workshop Conclusions
Workshop Conclusions - Updating monographs and methods (Part 2)
Workshop - Updating monographs & methods (Part 2)
- PDG and the ICH Q4B
- Plenary Sessions 13th & 15th June
- Posters
- Conf Poster Session
Poster Session, 13-15 June 2007
- Conf Poster Session
- Programme
- China Symposium, 23-24 May
- Final Prog China, 23-24 May 2007
The European Pharmacopoeia 6th Edition - Shanghai, 23-24 May 2007
- Final Prog China, 23-24 May 2007
- India Symposium, 4-5 May
- Programme Hyderabad 4-5 May 2007
Regulatory Submission Procedures in EU – APIs & Drug Products, Hyderabad, 4-5 May 2007
- Programme Hyderabad 4-5 May 2007
- Working across disciplines and borders, 6-7 December
- 2006
- 2006 Conference Archive
2006 Conference Proceedings & Presentations - Europe against counterfeit medicines, Moscow, 23-24 October
- Programme
- Speeches & Presentations
- Day 2, 24 October
(Some speeches are only available in French) - Introduction
- Day 1, 23 October
- Day 2, 24 October
- Declaration
- ETIF, 24-27 October 2006, Buenos Aires, Argent
- Avian Influenza Vaccines Symposium, Strasbourg, 19-20 October
- Programme
- Final Prog Avian Flu
Final Programme Avian Influenza Symposium, Strasbourg, 19-20 October
- Final Prog Avian Flu
- Proceedings
- Proceedings Avian Flu Vaccines
Proceedings of the symposium on Avian Influenza Vaccines
- Proceedings Avian Flu Vaccines
- Programme
- New Microbiology Chapters, Strasbourg, 2-3 October
- Programme
- Final Programme
Final Programme Microbiology Chapters Symposium, Strasbourg, 2-3 October
- Final Programme
- Proceedings
- Proceedings Microbiology Chapters
Proceedings of the symposium on New Microbiology Chapters
- Proceedings Microbiology Chapters
- Presentations
- Session II: Part 3 Slides
Session II: Alternative methods for control of microbiological quality (Part 3) - Session II: Part 2 Slides
Session II: Alternative methods for control of microbiological quality (Part 2) - Session II: Part 1 Slides
Session II: Alternative methods for control of microbiological quality (Part 1) - Session I: Part 2 Slides
Session I: Microbiological contamination non-sterile products (Part 2) - Session I: Part 1 Slides
Session I: Microbiological contamination of non-sterile products (Part 1) - Opening Session
Opening Session: New microbiology chapters
- Session II: Part 3 Slides
- Programme
- Impurities control: setting specifications for antibiotics and peptides, 21-22 September
- Programme
- Impurities Final programme
Impurities Control: setting specifications for antibiotics and peptides
- Impurities Final programme
- Proceedings
- Proceedings Impurities Control
Proceedings of the symposium on Impurities Control: Setting specifications for antibiotics and peptides
- Proceedings Impurities Control
- Presentations
- Antibiotics Workshops
Issues discussed and the conclusions reached during the Antibiotics workshops (21 September 2006) - Peptides Presentations
Impurities control: setting specifications for Peptides (22 September 2006) - Antibiotics Presentations
Impurities control: setting specifications for Antibiotics (21 September 2006)
- Antibiotics Workshops
- Programme
- CPhI China 2006, Shanghai, China
- Programme
- Prog CPhI Sympo
Programme European Pharmacopoeia Symposium, 27 June, 14h00-16h00, Hall W2, Meeting Room M9
- Prog CPhI Sympo
- Presentations
- The Certification of Suitability to the PhEur monograph (CEP) - Dr C. Pouget
The Certification of Suitability to the PhEur monograph (CEP) - The PhEur: General concepts & specific monographs - a detailed analysis - Dr C.Coune
- An overview of EDQM publications & online services - Mrs C. Larsen Le Tarnec
An overview of EDQM publications and online services
- The Certification of Suitability to the PhEur monograph (CEP) - Dr C. Pouget
- Programme
- IDMA
- Programme
- IDMA Final Prog
IDMA & EDQM Symposium, Mumbai, India, 23-24 January 2006
- IDMA Final Prog
- Programme
- 2006 Conference Archive
- 2005
- 2005 Proceedings Archive
2005 Conference Proceedings - IPC Congress, Hyderabad, India, 2-4 December
- Programme
- IPC Programme
Programme - IPC Congress, Hyderabad, India, 3 December 2005
- IPC Programme
- Programme
- Certification Conference, Istanbul, 27-28 October
- Programme
- Final Programme
Programme: International Conference on Certification, 27-28 October 2005
- Final Programme
- Presentations
- Plenary Session
- Plenary Presentations
Plenary Sessions Presentations, 27 & 28 October 2005
- Plenary Presentations
- Workshop: Revision & renewal procedures
- Rev Ren Presentations
Workshop 1: New procedures for the revision and renewal of certificates
- Rev Ren Presentations
- Workshop: Deficiencies in dossiers
- Deficiencies Presentations
Workshop 2: An outline of the main deficiencies in dossiers and how to avoid them
- Deficiencies Presentations
- Workshop: Sterile products
- Sterile Presentations
Workshop 3: Focus on sterile products - How to prepare a dossier and prepare for an inspection
- Sterile Presentations
- Workshop: Inspections
- Inspections Presentations
Workshop 4: Inspection of manufacturing sites: Chemical products
- Inspections Presentations
- Plenary Session
- Programme
- Counteract the counterfeiters, Strasbourg, 21-23 September
- Seminar Conclusions (Short version)
- Introduction
- Speakers
- Organising Committee
- Programme
- Speeches & Presentations
- XpoPharm 2005, Seoul, Rep of Korea, 1-2 September
- Programme
- Final Symposium Programme
XpoPharm 2005, Seoul, Rep of Korea, 2 September 2005
- Final Symposium Programme
- Programme
- OMCL Information Day, 27 May
- Programme
- OMCL Programme
OMCL Information Day Programme
- OMCL Programme
- Proceedings
- OMCL Info Day Proceedings
Proceedings of the OMCL Information Day
- OMCL Info Day Proceedings
- Presentations
- Session 2 Slides
Session 2: Common programmes of supervision activities for the network - Session 1 Slides
Session 1: Organisation & Structure of the Network
- Session 2 Slides
- Programme
- Alternatives to Whole Cell Pertussis Vaccine Potency Vaccine, 16 March
- Programme
- Proceedings
- Pertussis vaccine PA proceedings
Proceedings of the symposium on Alternative to whole cell pertussis vaccine potency assay
- Pertussis vaccine PA proceedings
- Presentations
- Quality of homoeopathic products in the new European legislative framework, 15 February
- Programme
- Proceedings
- Homoeopathy Proceedings
Proceedings
Quality of homoeopathic products: Conference Proceedings, 15 February 2005, Strasbourg, France
- Homoeopathy Proceedings
- Presentations
- 2005 Proceedings Archive
- 2004
- 2004 Proceedings Archive
2005 Conference Proceedings - Quality on the Move: Dynamics of the European Pharmacopoeia, 4-6 October
- Serological Potency Tests for Diphtheria and Other vaccines, 6-7 October
- 40th Anniversary European Pharmacopoeia 15 June
- Process Analytical Technologies 3-4 May
- 2004 Proceedings Archive
- 2003
- 2003 Conference Archive
2003 Conference Proceedings & Presentations - Microbiology Symposium, 5-6 May
- Programme
- Proceedings
- Presentations
- Microbiological sterilisation processes
Microbiological Sterilisation Processes. Slides session V - Microbiological Testing
Microbiological Testing of Raw Materials. Slides session IV - Microbiology Alternative New Control Methods
Slides session II - Development Culture Media
Slides session III - Microbiology International harmonisation
Slides session I - Microbiology Round table discussion
- Microbiological sterilisation processes
- Foot
- Cell and gene therapy Symposium, 24-25 February
- 2003 Conference Archive
- 2002
- 2002 Conference Archive
2002 Conference Proceedings & Presentations - 3Rs Symposium, 7-8 November
- Excipients, 4-5 April
- ETIF
- 2002 Conference Archive
- 2001
- Equine Influenza Vaccine, 10-11 December, Budapest, Hungary
- Certification of Suitability - New developments, 8-9 November, Athens, Greece
- Pestavirus Contamination of bovine sera and other bovine virus contamination, 29-30 March, Paris, France
- Future face of the European Pharmacopoeia, 8-9 February, Cannes, France
- Certification of TSE risk products, 11 January, Strasbourg, France
- 2000
- 1999
- Beyond Biologicals 2000: Challenge for Quality Standards in an evolving field, 27-29 September 1999, Strasbourg, France
- Proceedings
- Biologicals Beyond 2000, 27-29 September
Challenges for Quality Standards in an Evolving Field
- Biologicals Beyond 2000, 27-29 September
- Proceedings
- Certification of Suitability: New aspects of the Procedure, 11-12 November 1999, Berlin, Germany
- 1- Proceedings
- Certification of Suitability of Monographs of the European Pharmacopoeia, 11-12 November
New aspects of the procedure: How to prepare your dossiers
- Certification of Suitability of Monographs of the European Pharmacopoeia, 11-12 November
- 1- Proceedings
- Beyond Biologicals 2000: Challenge for Quality Standards in an evolving field, 27-29 September 1999, Strasbourg, France
- 1998
- 1997
- 1996
- Other interesting events
- HelpDesk EDQM HealthCare European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM Other
- Other EDQM HealthCare European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk
DEQM Conseil de l'Europe
7 allée Kastner, CS 30026,
F67081 Strasbourg, France
Tel. +33 (0)3 88 41 30 30
Fax +33 (0)3 88 41 27 71
Liens utiles
Clause de non responsabilité - Créé par 2exVia avec MasterEdit®
IMPORTANT : Compte tenu des délais potentiels de traduction, il est possible que le contenu du site en français et en anglais diffère légèrement durant le temps nécessaire à la traduction.
Nous vous recommandons de consulter le site en anglais pour vérifier si votre version française est à jour.