CATALOGUE 2013 Engl i s h

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EDQM Publications,
Databases and Reference Standards
8th Edition of the European
Pharmacopoeia (Ph. Eur.):
print version
Publication schedule:
15 July 2013: 8th Edition
1st October 2013: supplement 8.1
1st January 2014: supplement 8.2
Implementation schedule in the 37 member states of the
European Pharmacopoeia, including all of the European Union:
1st January 2014: 8th Edition
1st April 2014: supplement 8.1
1st July 2014: supplement 8.2
) Description:
The two initial volumes of the 8th Edition contain the complete set
of the 7th Edition texts and the texts adopted or revised at the
November 2012 session of the European Pharmacopoeia Commission,
including some 2224 monographs, 345 general chapters illustrated
with diagrams or chromatograms and 2500 descriptions of reagents.
Changes (inserted or deleted texts) are indicated in the margins.
The print version is available in English and French, the ofcial
languages of the Council of Europe.
) Practical information:
The 8th Edition is comprised of two initial volumes published in July
2013, which will be updated by non-cumulative supplements issued
three times a year following the decisions taken at each session of the
European Pharmacopoeia Commission. The 8th Edition will culminate
in a collection of eight non-cumulative supplements (8.1 to 8.8).
) Product details ISBN/ISSN
Book subscription 8th Edition 2013 (volumes 8.0-8.2) -
English version ISBN/ISSN: 978-92-871-7531-1
Book subscription 8th Edition 2013(volumes 8.0-8.2) -
French version ISBN/ISSN: 978-92-871-7530-4
Electronic version available online and on USB.
NEW: 8th Edition online accessible from tablets and
smartphones.
For customers who wish to buy several formats
at the same time, the EDQM now proposes
packages.
The electronic versions have the same publication
schedule as for the printed version.
Each new electronic version supersedes the
previous one. Online archives of the European
Pharmacopoeia are available to all current
subscribers.
) Description:
The electronic version contains all the European Pharmacopoeia texts
and provides additional features: full search functions and hyperlinks
to monographs, general methods, reagents and to the online
KNOWLEDGE database. Changes (inserted or deleted texts) are
indicated in both the HTML and PDF versions. It is possible to add
RSS feeds for specic queries.
The electronic version is bilingual (English and French).
) Practical information:
The online version can be accessed from the EDQM website. Users
must register the EPID code the rst time they use the online version
or the USB key.
Homepage: http://online.edqm.eu/
For technical requirements, see:
www.edqm.eu/en/EDQM-FAQ-and-Helpdesk-List-630.html?rubrique=22
) Product details ISBN/ISSN
Online subscription 8th Edition 2013 (Volumes 8.0- 8.2) Bilingual
ISBN/ISSN: 978-92-871-7536-6
USB Stick subscription 8th Edition 2013 (Volumes 8.0- 8.2) Bilingual
ISBN/ISSN: 978-92-871-7535-9
Pricing structure and ordering: EDQM web store,
www.edqm.eu/store
EDQM PUBLICATIONS,
DATABASES AND
REFERENCE STANDARDS
THE EUROPEAN PHARMACOPOEIA COLLECTION
European
P
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acopoeia
7.0

volume 1 01/2011
European
P
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7.0

volume 1 01/2011
Technical Guides
) Description:
The EDQM has always provided high quality technical information.
The Technical Guides are regularly revised and extended.
) Practical information:
Download PDFs free of charge at:
www.edqm.eu/en/Technical-Guides-589.html
European Pharmacopoeia Style Guide
) Description:
The Style Guide has been produced to help in the preparation of
monographs for the European Pharmacopoeia.
) Practical information:
Download the PDF free of charge at:
www.edqm.eu/en/Technical-Guides-589.html
CombiStats: a computer program for statistical
analysis
) Description:
This software can perform calculations according to chapter 5.3 of
the European Pharmacopoeia (8th Edition).
) Practical information:
Further information and a free demonstration at:
www.edqm.eu/en/combistats-635.html
and http://combistats.edqm.eu
Free databases
Do you have a question on a substance or a method of analysis in
the European Pharmacopoeia? Before using the HelpDesk do not
forget to consult the KNOWLEDGE database.
The KNOWLEDGE database will tell you if a substance or a method
of analysis is part of the work programme of the European Pharmacopoeia,
its state of work, the history of a monograph since the 5th Edition, the
volume of the European Pharmacopoeia in which the ofcial obligatory
text can be found, etc.
Also available are the trade name(s) of some of the reagents, such as
those used in chromatography columns or biological kits used to carry
out certain tests, downloadable reference chromatograms, technical
information explaining how to carry out the described tests, etc.
On the Internet: www.edqm.eu/en/edqm-databases-10.html
VERIFY THE AUTHENTICITY
OF YOUR PUBLICATION
The EDQM applies a hologram to all its publications and gives each a
unique Publication ID (EPID code). This code is necessary if you wish
to register your publication, check its authenticity or have access to our
user support team (HelpDesk). To check the authenticity and register a
publication, go to: www.edqm.eu/register/. The EPID code is sent by
email when you purchase the USB key or any of the online versions of
the European Pharmacopoeia.
Colourful areas
Mirrored minitext
Colourful letters and stars
Lens efect
PHARMEUROPA ONLI NE
Pharmeuropa and Pharmeuropa Bio & Scientic Notes
available online free of charge
) Contents:
Public inquiries on draft European texts or on matters of general
policy.
Latest ofcial announcements on freshly adopted monographs.
Latest news on Pharmacopoeial harmonisation.
A readers tribune.
and access to three databases:
Texts for comment. Contains proposals for new and revised
monographs and general texts that are intended for inclusion in the
European Pharmacopoeia and are submitted for public comment.
Pharmeuropa Bio & Scientic Notes. Contains all the news in the
biological standardisation area and scientic articles linked to the
work of the European Pharmacopoeia.
Pharmeuropa archives. Contains past issues of Pharmeuropa.
) Practical information:
Online version http://pharmeuropa.edqm.eu/
It is necessary to register in order to have access.
) Product details ISBN/ISSN
Online PHARMEUROPA English/French version ISBN/ISSN: 2225-2339
ONLINE PHARMEUROPA Bio & Scientic Notes
ISBN/ISSN: 2075-2504 English version
OTHER PRODUCTS OF INTEREST
OMCL NETWORK GUIDELINES/PROCEDURES
At the end of 2012, the Standard Terms database held 771 unique
terms, with 28 new terms added during the year.
) Contents:
The List of Standard Terms covers pharmaceutical dosage forms,
patient-friendly terms, routes and methods of administration,
containers, closures and delivery devices and combined terms for
medicines for human and veterinary use.
This list, which has European Union Guideline status, must be used
in licensing dossiers for medicines (i.e. the Application form of the
dossier and the Summary of Product Characteristics).
The list comprises several hundred terms in 32 languages.
) Practical information:
Online version: www.edqm.eu/StandardTerms
Clients who purchased the last printed version of this publication
must rst register the EPID number on the inside-front cover in order
to gain access to the online database.
Registration: www.edqm.eu/register
) Product details ISBN/ISSN
Online Version Standard Terms
ISBN/ISSN : 92-871-5734-0
Pricing structure and
ordering: EDQM web store,
www.edqm.eu/store
LIST OF STANDARD TERMS 2012
These Guidelines have been developed for application within the
general European Ofcial Medicines Control Laboratories Network
(OMCL Network).
Product Specic Guidelines for Ofcial Control
Authority Batch Release of Human Biological
Medicinal Products & OCABR/Ofcial Batch
Protocol Review of Immunological Veterinary
Medicinal products
NEW: 1 new and 9 revised human guidelines/procedures and
17 revised veterinary guidelines/procedures in 2012.
61 product-specic guidelines and procedures related to OCABR of
human biological medicinal products, as well as 23 guidelines,
procedures and model protocol templates for immunological
veterinary medicinal products are available and regularly updated.
) Practical information:
Free, downloadable product-specic guidelines and procedures from
the website: www.edqm.eu/en/Human-OCABR-Guidelines-1530.html
and www.edqm.eu/en/veterinary-biologicals-634.html
Quality Management (QM) Guidelines
21 guidelines currently available, covering a large variety of topics.
) Practical information:
They are available in PDF format for free from the website:
www.edqm.eu/en/Quality-Management-QM-Guidelines-86.html
ORDERING EDQM PUBLICATIONS:
www.edqm.eu/store
Orders can be sent to the EDQM by:

post to the Sales Section, EDQM - Council of Europe, 7 alle Kastner,

CS 30026, 67081 Strasbourg, France.

fax to the Sales Section at +33 (0)3 88 41 27 71.

email to orders@edqm.eu with the order form as an attachment,

and

via the internet at www.edqm.eu/store.

Details on prices and availability can be found on the website under
each product item. Remember that if you order online, you will beneft
from a 10% discount.
There are several ways to pay your invoice: by cheque, bank transfer or
credit card via the internet (www.edqm.eu/store).
Guide to the Preparation, Use and Quality
Assurance of Blood Components -
17th Edition (2013)
) Contents:
This guide contains a compendium of principles and
standards designed to ensure the safety, efcacy and
quality of blood components.
English: print and online (PDF); French: online (PDF) only.
) Product details ISBN/ISSN
Guide to the Preparation, Use and Quality Assurance of Blood
Components, 17th Edition (2013) English version
ISBN/ISSN: 978-92-871-7637-0
Guide to the Quality and Safety
of Organs for Transplantation -
5th Edition (2013)
NEW: Guide to the Quality and Safety of
Tissues and Cells for human application
1st Edition (2013)
) Contents:
The 5th Edition provides guidance on the transplantation of organs
of human origin for therapeutic purposes.
From 2013, a separate Guide covering the donation of tissues and cells
updates Chapters 7 and 8 of the previous edition of the Transplantation
Guide.
Guides are available in print or online (PDF format) in English.
) Product details ISBN/ISSN
Guide to the Quality and Safety of Organs for Transplantation - 5th
Edition (2013) English version
ISBN/ISSN: 978-92-871-7638-7
Guide to the Quality and Safety of Tissues and Cells for human
application 1st Edition (2013) English version
ISBN/ISSN: 978-92-871-7639-4
Practical information:
The online versions of the Guides are available to clients who have
purchased the book version. Clients must register their publication
using the EPID code on the back cover. Existing clients go to:
http://TOTS.edqm.eu. Registration: www.edqm.eu/register.
Pricing structure and ordering: EDQM web store,
www.edqm.eu/store
BLOOD TRANSFUSION & ORGAN TRANSPLANTATION
PUBLICATION ON PHARMACEUTICAL PRACTICES
Policies and practices for a safer, more
responsible and cost-effective health
system (2012)
This publication is a report on the work done at the
European level on the importance of pharmaceutical care
and what policies and practices to consider for a safer, more responsible
and cost-effective health system.
This publication is available to download for free (PDF format) from
the EDQM website: www.edqm.eu/en/pharmaceutical-care-1517.html
Safe Cosmetics for Young Children - 1st Edition (2012)
A Guide for Manufacturers and Safety Assessors prepared by the
Committee of Experts on Cosmetic Products (P-SC-COS).
) Product details ISBN/ISSN
Safe Cosmetics for Young Children - 1st Edition 2012 English
version ISBN/ISSN: 978-92-871-7360-7
To consult prices and to order any of the EDQMs publications,
please go to: www.edqm.eu/store
Pharmaceutical Care: Where do we
stand - Where should we go?
A 2009 Survey Report on key concepts in pharmaceutical
care, quality assessment of pharmaceutical care in
Europe and sources of information. It is available in
book format in English.
) Product details ISBN/ISSN
Pharmaceutical Care: Where do we stand - Where should we go?
English version : ISBN/ISSN: 978-92-871-6712-5
NEW: Trends and observations on the collection, testing and
use of blood and blood components in Europe Report 2001-2008
NEW: The collection, testing and use of blood and blood
components in Europe Report 2009 and 2010
NEW: Blood and Blood Components - Council of Europe
Resolutions, Recommendations and Convention (1st Edition)
A compilation of all of the Council of Europes Conventions,
Resolutions, Recommendations and Reports concerning transfusion.
NEW: Organ, tissue and cells: safety, quality and ethical matters
concerning procurement, storage and transplantation (2nd Edition)
A compilation of all of the Council of Europes Conventions,
Resolutions, Recommendations and Reports concerning transfusion.
Publications available free of charge in PDF format from the EDQM
website: www.edqm.eu/en/blood-organ-guides-1131.html and directly
online for clients who have purchased the Guides on Blood Transfusion,
Organ transplantation and Tissues and Cells: http://TOTS.edqm.eu.
OTHER PRODUCTS OF I NTEREST
PUBLICATION ON COSMETICS
ORDERING EDQM REFERENCE STANDARDS
Details of prices, availability and the terms and conditions of supply of
reference standards can be found at: http://crs.edqm.eu.
Orders can be sent to the EDQM by:

fax to the Sales Section at +33 (0)3 88 41 27 71.

by email to orders@edqm.eu with the order form as an attachment,

and

via the internet using the online order form available at:
www.edqm.eu/en/CRS-order-form-697.html
Payment can be made by cheque, bank transfer or credit card via the
internet (www.edqm.eu/store)
REFERENCE STANDARDS & SUBSTANCES
European Pharmacopoeia Reference standards:
a guarantee of quality and reliability
114 new CRS established in 2012
A collection of 2537 items available.
The European Pharmacopoeia Reference Standards are ofcially valid
for the uses prescribed in the European Pharmacopoeia monographs.
The batches of reference substances and preparations are selected
and checked at the EDQM laboratory using the methods prescribed
in the monographs. The establishment reports are adopted by the
European Pharmacopoeia Commission.
The European Pharmacopoeia Reference Standards catalogue covers chemical,
herbal and biological standards and materials and reference spectra.
Over 2500 reference standards and a list of newly-adopted reference
standards are available in the online catalogue: http://crs.edqm.eu.
Search by catalogue code, reference standard name, monograph number
or CAS number to quickly locate the standard you need. Information
is available on the assigned value, batch validity, availability, price and
origin of reference standards (animal, herbal, synthetic, recombinant
or fermentation) and much more is also given in the online reference
standards database, which is updated daily.
Practical information: A Batch Validity Statement (BVS) for reference
standards enables users to verify validity dates of batches supplied.
The EDQM also provides safety data sheets (SDS) and leaets online
(PDF format), which can be printed or saved to your desktop. Safety
Data Sheets and leaets are published online at: http://crs.edqm.eu/
WHO International Standards for Antibiotics (ISA)
and WHO International Chemical Reference
Substances (ICRS)
NEW: 2 replacement batches for ISA have been established;
the second international standard for Neomycin B and the
third international standard for Neomycin.
17 ICRS establishment studies were completed in 2012.
The EDQM distributes WHO International Standards for Antibiotics
(ISA) and WHO International Chemical Reference Substances (ICRS).
ISA standards play an essential role in the standardisation and quality
control of antibiotic material and pharmaceutical products. They are
generally intended for the establishment of secondary standards used
at regional or national level in tests or routine assays.
ICRS are primary, chemical reference substances established on the
advice of the WHO Expert Committee on Specications for
Pharmaceutical Preparations. They are supplied primarily for use in
physical and chemical tests and assays described in the International
Pharmacopoeia. The ICRS may be used to calibrate secondary
standards.
Practical information: The EDQM also provides safety data sheets
(SDS), leaets and study reports (only for ISA) online (PDF format),
which can be printed or saved to your desktop.
IMPORTANT INFORMATION FOR USERS
Register today for our free e-mail E-Newsletter at:
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Subscribers receive an e-mail each month with information on EDQM
news, publications and events.
Free user support service Frequently Asked Questions and the
EDQM HelpDesk
The Frequently Asked Questions (FAQs) highlight topics and
specic questions that are often asked of the EDQM. Please check
the FAQ section to see if your question has already been answered:
www.edqm.eu/en/FAQ-Helpdesk-List-630.html
If your question is not answered by the FAQs, contact the EDQM
via the HelpDesk.
The user support service HelpDesk is accessible from the website
www.edqm.eu/hd and allows users to send their questions to the
EDQM from a single access point. The HelpDesk allows the EDQM
to respond quickly and consistently to users questions.
How to contact the EDQM
By phone: +33 (0)3 88 41 30 30* (Main automatic switchboard)
By fax: +33 (0)3 88 41 27 71*
To send a question to the EDQM: use the user support HelpDesk
available on our website: www.edqm.eu/hd
Postal address
European Directorate for the Quality of Medicines & HealthCare
(EDQM), Council of Europe
7 alle Kastner, CS 30026,
F-67081 Strasbourg France
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