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EDQMPublications

EDQMPublications

Mrs Caroline Larsen Le TarnecHead Public Relations & Documentation Division

C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 1

The EuropeanPharmacopoeiaThe EuropeanPharmacopoeia

C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved

SIXTH EDITION: 3 Suppl/yearPublication status: Last supplement 6.8 released in December 09Implemented in July 2010Non-cumulativeChange bars indicate changes to previous version.

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IntroductionIntroduction

GeneralNoticesGeneralGeneralNoticesNotices

GeneralTextsGeneralGeneralTextsTexts

GeneralMonographsGeneralMonographs

General organisation: volume 1General organisation: volume 1


Dosage formsDosage forms

VaccinesVaccines

ImmunoseraImmunosera

Radiopharm.Radiopharm.

SuturesSutures

HomoeopathyHomoeopathy

GeneralNoticesGeneralNotices

GeneralTextsGeneralTexts

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General organisation: volume 2General organisation: volume 2


Other specificmonographs

Other specificmonographs

IndexIndex

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.

6th Edition Supplement

Publication Schedule

Implementation Date

6.0 01/06/2007 01/01/20086.1 01/10/2007 01/04/20086.2 01/01/2008 01/07/20086.3 01/06/2008 01/01/20096.4 (+reagents) 01/10/2008 01/04/20096.5 01/01/2009 01/07/20096.6 01/06/2009 01/01/20106.7 (+reagents) 01/10/2009 01/04/20106.8 01/01/2010 01/07/20107.0 01/06/2010 01/01/2011

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European PharmacopoeiaEuropean Pharmacopoeia• Electronic versions

– ~ same price, same publication programme – cumulative– available for standalone computers (since 6.6 on DVD) – since supplement 6.6: a new publication software (with

functionality of the online version) is also on the DVD (7th edition: only new software will be available!)

– available online (internet)– new: monthly updated Spanish version (~200 texts/month)– new: archive version for current subscribers – licence model:

• 1 licence = 1 simultaneous user, maximum 2 computers

H-J. Bigalke, 08/12/09 ©2009 EDQM, Council of Europe, All rights reserved

Archive VersionArchive Version


Spanish VersionSpanish Version


The European Pharmacopoeia 7th

EditionThe European Pharmacopoeia 7th

Edition


SEVENTH EDITION: 3 Suppl/yearPublication (about): July, September, DecemberImplemented in July, January, AprilNon-cumulativeChange bars indicate changes to previous version.

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What has changed since the 6th Ed.?What has changed since the 6th Ed.?A short selection of the most interesting topics:• New Chapter 5.15: Functionality-related

characteristics of excipients;• Revision of the chapters:2.8.3 Pesticide residues

2.6.12 : Microbiological examination of non-sterile products: microbial enumeration tests

2.6.13 : Microbiological examination of non-sterile products: test for specified micro-organisms

• . C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 18

What has changed since the 6th Ed?What has changed since the 6th Ed?2.2.46 : Chromatographic separation techniques 2.8.22 : Determination of ochratoxin A in herbal drugs5.1.4 : Microbiological quality of non-sterile

pharmaceutical preparation and substances for pharmaceutical use


What has changed since the 6th Ed?What has changed since the 6th Ed?

NEW Indication of the status of pharmacopoeial harmonization between EP, USP and JP

In a chapter 5.8 : Pharmacopoeial harmonization of the following chapters Electrophoresis (2.2.31); Capillary electrophoresis (2.2.47); Isoelectric focusing (2.2.54); Peptide mapping (2.2.55); Amino acid analysis (2.2.56); Friability of uncoated tablets (2.9.7); Specific surface area by gas adsorption (2.9.26); Powder flow (2.9.36); Optical microscopy (2.9.37); Particle-size distribution estimation by analytical sieving (2.9.38)


What has changed since the 6th Ed?What has changed since the 6th Ed?

• New important monographs:Valsartan; Ziprasidone hydrochloride monohydrate;

Teicoplanin; Telmisartan; Tiotropium bromide; Saquinavir mesilate; Sevoflurane; Pantoprazole sod. Sesquihydrate; Pramipexole dihydrochloride monohydrate; Raloxifene hydrochloride; Levetiracetam; Meropenem; Irbesartan; Fluvastatin sodium ; Adapalene; Docetaxel trihydrate; Entacapone; Epinastine hydrochloride


PharmeuropaPharmeuropa

• Published quarterly• A NEW EDITORIAL

LINE• Draft monographs

for comment• News and general

information• Readers’ tribune

C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved22

Pharmeuropa Bio & Scientific NotesPharmeuropa Bio & Scientific Notes

• Results of collaborative trials on the establishment of biological reference substances

• Scientific articles related to the European Pharmacopoeia

• Searchable on scientific search engines (PubMed in NLM)

• Published twice a year


Standard TermsStandard Terms

A glossary in 31 languages of: • pharmaceutical

dosage forms• routes of

administration• containers


Standard TermsStandard Terms

Very useful for: • MA dossiers• Leaflets• Labels


Standard Terms OnlineStandard Terms Online

• Address: http://http://www.edqm.euwww.edqm.eu//StandardTermsStandardTerms//

• Based on Unicode character encoding, available only on the most recentcomputer operating systems

• No printed version available any more


Blood componentsBlood components

• 14th Edition (2008) Guidelines and principlesfor the preparation, use and quality assurance ofblood components

• Contains measuresdesigned to ensure thesafety, efficacy andquality of bloodcomponents

• Particularly intended for all those working in bloodtransfusion services


Organ transplantationOrgan transplantation• Guide to safety and quality assurance for the

transplantation of organs, tissues and cells - 3rd edition(2007)

• Currently published by the Council of Europe, in the future to bepublished by the EDQM

• Guidance to maximise the quality of organs, tissues and cells, and thereby the success rate of transplants, and to minimise risks

• Includes safety and quality assurance standards for theprocurement, preservation, processing and distribution oforgans, tissues and cells of human origin (allogenic andautologous) used for transplantation purposes


NEW Pharmaceutical Care:NEW Pharmaceutical Care:


• report on the current awareness and understanding of pharmaceutical care• approaches for quality assessment• implementation of pharmaceutical care in practice• required competences and skills• conclusions of 58 replies from 17 countries

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Technical guidesTechnical guides• Technical guides for:

– the elaboration of monographs– the elaboration of monographs on synthetic peptides and

recombinant DNA proteins– structure & nomenclature of chemical formulae– herbal drugs and herbal drug preparations– fatty oils and derivatives– vaccines and other immunological human medicinal products

• European Pharmacopoeia Style Guide• Free to download: www.edqm.eu Products & Services


Combistats™Combistats™

• A statistical software specifically designed to use together with general chapter 5.3 Statistical analysis of results

• Published directly by the EDQM


Combistats™Combistats™• For more information about the software

please contact:[email protected]

• Website:http://combistats.edqm.eu/where a free demo version can be downloaded


Checking the authenticityChecking the authenticity• Users of the Pharmacopoeia are advised to

register their copy, using our website:–– https://https://www.edqm.euwww.edqm.eu/register/register

• Register with the unique ID (EPID) number shown on the label

• This registration is required for– Users of the electronic versions (password/activation)– Accessing our helpdesk


Checking the authenticity -the hologram -

Checking the authenticity -the hologram -

1. Colourful areas

2. Mirrored minitext

3. Colourful letters/stars

4. Lens effect


• Q: I am only interested in one monograph. Can I just get a copy of that?

• A: No• Why? The specific monographs contain

a number of cross references to other parts of the publication (general monographs, general methods…), so a monograph is never self-sufficient.


FAQ on publicationsFAQ on publications

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Questions?Questions?

• EDQM Helpdesk: www.edqm.eu/hd• Select the right thematic and ask your

question• 90 EDQM staff in back office to answer all

questions received• The only channel to use to contact EDQM for

technical, scientific and commercial mattersC. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 44

Distributors in India (1)Distributors in India (1)• UNITED BOOKS AND

PERIODICALS7, Vishwadham, Prabhat Clny.Rd. n°9 Santacruz (East) 400 055 MUMBAI

TEL: +91 22 2611 6909 or +91 22 2617 7370FAX: +91 22 2610 5852

CONTACT: Rahul M. Gavankar,Email:[email protected] [email protected]

• EDUCATIONAL BOOK CENTRE

33, Bhagwan Bhuvan, 196 Samuel Street400 009 MUMBAI

TEL: +91 22 2560 3324; FAX: +91 22 2568 5341

CONTACT: Mukesh H. Doshi, Email: [email protected]


Distributors in India (2)Distributors in India (2)• M/s SHAH BOOK HOUSE PVT

LTDDevka Mahal, Opp CentralBank, Bank StreetKoti, 500095 HYDERABAD

TEL: +91 40 2344 5622; FAX: +91 40 2344 5611

CONTACT: Anil Shah,Email:[email protected]

• KAMAL UDYOGF-4, 1st Floor, Velho TradeCentreGen. B. Guesdes Road, Next toGoa Sahakar BhandarPanaji, 403001 GOA

TEL: +91 832 2437 148; FAX: +91 222 5642 331

Email: [email protected]


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