EDQM Publications

EDQM 

Publications 

Mrs Caroline Larsen Le Tarnec 

Head Public Relations & 

Documentation Division 

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

The EuropeanPharmacopoeia 

SIXTH EDITION: 3 

Suppl/year 

Publication status: Last 

supplement 6.8 released in 

December 09 

Implemented in July 2010 

Non-cumulative 

Change bars indicate 

changes to previous version. 

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

2

General organisation: volume 1 

Introduction 

General 

Notices 

General 

Texts 

General 

Monographs 

Dosage forms 

Vaccines 

Immunosera 

Radiopharm. 

Sutures 

Homoeopathy 


3

General organisation: volume 2 

Other specific 

monographs 

Index 


4

6th Edition 

Supplement 

Publication 

Schedule 

Implementation 

Date 

6.0 01/06/2007 01/01/2008 

6.1 01/10/2007 01/04/2008 

6.2 01/01/2008 01/07/2008 

6.3 . 

01/06/2008 01/01/2009 

6.4 (+reagents) 01/10/2008 01/04/2009 

6.5 01/01/2009 01/07/2009 

6.6 01/06/2009 01/01/2010 

6.7 (+reagents) 01/10/2009 01/04/2010 

6.8 01/01/2010 01/07/2010 

7.0 01/06/2010 01/01/2011 


5

European 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 (7 th 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 Version 


Spanish Version 









The European Pharmacopoeia 7 th 

Edition 

SEVENTH EDITION: 

3 Suppl/year 

Publication (about): July, 

September, December 

Implemented in July, 

January, April 

Non-cumulative 

Change bars indicate 

changes to previous version. 


17

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? 

2.2.46 : Chromatographic separation techniques 

2.8.22 : Determination of ochratoxin A in herbal drugs 

5.1.4 : Microbiological quality of non-sterile 

pharmaceutical preparation and substances for 

pharmaceutical use 



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) 



• 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 


Pharmeuropa 

• Published quarterly 

• A NEW EDITORIAL 

LINE 

• Draft monographs 

for comment 

• News and general 

information 

• Readers’ tribune 


22

Pharmeuropa 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 Terms 

A glossary in 31 

languages of: 

• pharmaceutical 

dosage forms 

• routes of 

administration 

• containers 


Standard Terms 

Very useful for: 

• MA dossiers 

• Leaflets 

• Labels 


Standard Terms Online 

• Address: 

http://www.edqm.eu 

www.edqm.eu/StandardTerms/ 

• Based on Unicode character encoding, 

available only on the most recent 

computer operating systems 

• No printed version available any more 



Blood components 

• 14th Edition (2008) 

Guidelines and principles 

for the preparation, use 

and quality assurance of 

blood components 

• Contains measures 

designed to ensure the 

safety, efficacy and 

quality of blood 

components 

• Particularly intended for 

all those working in blood 

transfusion services 


Organ 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 be 

published 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 the 

procurement, preservation, processing and distribution of 

organs, tissues and cells of human origin (allogenic and 

autologous) used for transplantation purposes 


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 


36

Technical 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 

• A statistical software specifically 

designed to use together with general 

chapter 5.3 Statistical analysis of results 

• Published directly by the EDQM 



Combistats 

• For more information about the software 

please contact: 

arnold.daas@edqm.eu 

• Website: 

http://combistats.edqm.eu/ 

where a free demo version can be 

downloaded 


Checking the authenticity 

• Users of the Pharmacopoeia are advised to 

register their copy, using our website: 

– https://www.edqm.eu 

www.edqm.eu/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 - 

1. Colourful areas 

2. Mirrored minitext 

3. Colourful 

letters/stars 

4. Lens effect 

the hologram - 


• Q: I am only interested in one 

monograph. Can I just get a copy of 

that? 

•A: No 

FAQ on publications 

• 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. 


43

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 matters 


Distributors in India (1) 

• UNITED BOOKS AND 

PERIODICALS 

7, Vishwadham, Prabhat Clny. 

Rd. n°9 Santacruz (East) 

400 055 MUMBAI 

TEL: +91 22 2611 6909 or 

+91 22 2617 7370 

FAX: +91 22 2610 5852 

CONTACT: Rahul M. Gavankar, 

Email: 

unitedbooks@mtnl.net.in or 

unitedbooks@gmail.com 

• EDUCATIONAL BOOK CENTRE 

33, Bhagwan Bhuvan, 

196 Samuel Street 

400 009 MUMBAI 

TEL: +91 22 2560 3324; 

FAX: +91 22 2568 5341 

CONTACT: Mukesh H. Doshi, 

Email: ebc@vsnl.net 


Distributors in India (2) 

• M/s SHAH BOOK HOUSE PVT 

LTD 

Devka Mahal, Opp Central 

Bank, Bank Street 

Koti, 500095 HYDERABAD 

TEL: +91 40 2344 5622; 

FAX: +91 40 2344 5611 

CONTACT: Anil Shah, 

Email:orders@shahbookhouse.com 

• KAMAL UDYOG 

F-4, 1st Floor, Velho Trade 

Centre 

Gen. B. Guesdes Road, Next to 

Goa Sahakar Bhandar 

Panaji, 403001 GOA 

TEL: +91 832 2437 148; 

FAX: +91 222 5642 331 

Email: sales@kamaludyog.com

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