Neue Ausgabe von Pharmeuropa

Es wird außerdem auf eine überarbeitete "List of Standard Terms" (Stand: 2004) in 27 europäischen Sprachen (neu sind die fünf Sprachen Lettisch, Estnisch, Litauisch, Rumänisch und Maltesisch) hingewiesen. Die neue Ausgabe ist nun verfügbar.

Zur Information sind die Inhaltsverzeichnisse von Pharmacopoeial Forum (USP) Vol. 31, No. 1 (Jan – Febr 2005) und No. 2 (Mar – Apr 2005) abgedruckt.

Das Inhaltsverzeichnis von "Pharmeuropa®" Vol. 17.2, April 2005 ist nachstehend abgedruckt. Stellungnahmen sollten bis 30. Juni 2005 an das Bundesinstitut für Arzneimittel und Medizinprodukte, Geschäftsstelle der Arzneibuch-Kommissionen, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn

mit Kopie an das

European Directorate for the Quality of Medicines,

B.P. 907, F 67029 Strasbourg Cedex 1 (France), Tel. (3 33) 88 41 20 36, Fax (3 33) 88 41 27 71, E-Mail: info@pheur.org

gerichtet werden.

Bearbeitet und mitgeteilt von Dr. Gert Auterhoff, Stellvertr. Geschäftsführer Medizin und Pharmazie, Geschäftsfeld Pharmazie, Bundesverband der Pharmazeutischen Industrie e. V. (BPI), Karlstr. 21, 60329 Frankfurt/Main (Germany)

Inhalt von Pharmeuropa 17.2, April 2005

Publication of Supplements 5.3

Annual Report of Activities of the EDQM

General Information

Electronic version of the 5th Edition of the European Pharmacopoeia CRS: conditions of sale List of the CRS adopted at the November 2004 session List of the texts adopted at the November 2004 session Knowledge database Updated work programme of the European Pharmacopoeia (November 2004) List of codes of groups of experts Elaboration/Revision of a monograph (Procedure 1) Pharmeuropa Bio Proceedings of conferences of the EDQM List of Standard Terms: 5th Edition (new)

Press releases

• The United states food and drug administration is granted observer status to the European Pharmacopoeia Commission
• Quality of homoeopathic products in the new European legislative framework (Strasbourg, France, 15 February 2005)

International Conferences

Training Sessions on the 5th Edition of the European Pharmacopoeia: Chemicals

20 – 21 April 2005, New Jersey, United States 1 – 2 December 2005, Strasbourg, France

New Announcement! The Quality Control of Medicinal Products: Place and Role of the European OMCL Network within the Regulatory Framework in Europe

27 May 2005, Rome, Italy

Key Role for Quality within the Regulatory System

Symposium EDQM included in the Pharmaceutical Sciences Fair 16 June 2005 (morning session), Nice, France

New Announcement! Certification Procedure

27 – 28 October 2005, Istanbul, Turkey

Certification of Suitability of the Monographs of the Ph. Eur.

Content of the dossier for a substance for chemical purity and microbiological quality evaluation (revision of Annex I Resolution AP-CSP (03) 5 as amended) List of certificates

Draft Monographs and General Texts for Comment

Acemetacin Amiodarone hydrochloride Atropine sulphate Bisacodyl Cefepime dihydrochloride monohydrate Ceftriaxone sodium Citalopram hydrobromide Citalopram hydrochloride Cloxacillin sodium Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen content) Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen content) Flocculation value (Lf) of diphteria and tetanus toxins and toxoids (2.7.27) Human albumin solution Human normal immunoglobulin Human normal immunoglobulin for intravenous administration Hydrocodone hydrogen tartrate 2.5-hydrate In vivo assay of poliomyelitis vaccine (inactivated) (2.7.20) Levodopa Manganese glycerophosphate hydrated Measles, mumps and rubella vaccine (live) Measles vaccine (live) Mepyramine maleate Mumps vaccine (live) Naproxen sodium Nickel in hydrogenated vegetable oils (2.4.31) Olive oil, refined Paclitaxel Rhubarb Rubella vaccine (live) Sulfadimidine Tamsulosin hydrochloride Telmisartan Tibolone Trolamine Varicella vaccine (live) Viral safety (5.1.7) Yohimbine hydrochloride Herbal powder illustration: Lemon verbena leaf

International Harmonisation

Hypromellose phthalate Silicia, colloidal anhydrous Silicia, colloidal hydrated Contents of the USP Forum (Vol. 31, No. 1 and 2)