EDQMOverview

of Pharmacopoeia related products & services

www.edqm.eu www.edqm.eu/store

2019

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Ph. Eur. 10th Edition: ‘Access to quality standards applicable in Europe from 1 January 2020’

■ The Pharmacopoeia you need to comply with to market your products in 38 European countries and beyond.

■ Delivers crucial information earlier than any other Pharmacopoeia.

■ Approximately one third of its content is new or revised*.

■ Available in print and electronic versions, with new features and direct access to complementary information (EDQM’s “Knowledge Database”).

■ Online Helpdesk and FAQs: https://go.edqm.eu/HDpubs

■ Product information and pricing: www.edqm.eu/store and orders@edqm.eu

Pharmeuropa Online: the Ph. Eur. free forum

■ Ph. Eur. texts for comment: published continuously, with 4 deadlines for comments per year.

■ Pharmeuropa Bio & Scientific Notes: news in the biological standardisation area and scientific articles linked to the work of the Ph. Eur.

■ Pharmeuropa archives: free access to 30 years of electronic archives.

■ https://go.edqm.eu/pharmeuropa

Other products of interest:

■ CombiStats™: statistical analysis software for calculations in accordance with chapter 5.3 of the European Pharmacopoeia. Available in online format with an annual licence. https://go.edqm.eu/combistats.

■ Technical Guides and Ph. Eur. Style Guide available here: https://go.edqm.eu/techguid

EUROPEAN PHARMACOPOEIA (Ph. Eur.)

1

* Compared to 9.0

European Pharmacopoeia RS: essential to ensure the quality of medicines and their ingredients

■ The only pharmacopoeial source to verify compliance with the legal requirements in the European Pharmacopoeia.

■ Nearly 3000 RS (chemicals, biologicals and herbals) used in more than 110 countries.

■ Quality and scientific excellence in establishing pharmacopoeial RS.

■ Developed through the technical expertise of the EDQM: ISO 9001 certified and ISO 17025 accredited.

■ Online Catalogue updated daily.

Extract of the CRS online catalogue

■ Dedicated customer support through the EDQM’s Online HelpDesk https://go.edqm.eu/HDrs and access to specific training resources.

■ Product information and pricing: https://go.edqm.eu/crsdb

WHO International Standards for Antibiotics (ISA) and Chemical Reference Substances (ICRS)

■ ISA: reference substances for use as primary standards in microbiological testing of antibiotics. ISA can also be used by regional or national pharmacopoeias to establish secondary standards.

■ ICRS: primary chemical reference substances, supplied for use in physical and chemical tests and assays described in the International Pharmacopoeia or other WHO quality assurance documents.

■ The EDQM distributes WHO ISA and WHO ICRS.

■ Online Catalogues updated daily.

■ Safety Data Sheets (SDS), leaflets and study reports (only for ISA) available online (PDF format): https://go.edqm.eu/ISAen and https://go.edqm.eu/ICRSen

REFERENCE STANDARDS (RS)

CEPs: Make a difference to your business

■ For active substances or excipients covered by a monograph in the Ph. Eur., including herbal products and all products with TSE risk.

■ CEPs replace data in the quality part of Marketing Authorisation Applications (MAA) and facilitate the management of MAA.

■ Centralised evaluation of quality dossiers.

■ Recognised throughout all 38 Ph. Eur. member states and beyond.

■ Complemented by a risk-based inspection programme of manufacturing sites.

■ For more information on the Certification procedure: https://go.edqm.eu/CEP

■ For more information on a given substance, certificate holder: https://go.edqm.eu/cepdatabase

Events, training sessions, webinars and conferences organised all year round

■ Unique opportunities to interact directly with the EDQM, experts and key speakers from around the world. https://go.edqm.eu/events

REFERENCE STANDARDS (RS) CERTIFICATION OF SUITABILITY TO THE MONOGRAPHS OF THE Ph. Eur. (CEP)

OTHER SERVICES OF INTEREST Monthly EDQM e-Newsletter

■ The best approach to keep in touch with the EDQM https://go.edqm.eu/Newsletter

For any question use the EDQM Free user support service

■ Includes Frequently Asked Questions (FAQ) and access to the HelpDesk to ask your question. Please check the FAQ section to see if your question has already been answered: Publications: https://go.edqm.eu/HDpubs Reference standards: https://go.edqm.eu/HDrs

ORDERING INFORMATION

All orders are subjected to our Terms and Conditions of Sales available here: https://go.edqm.eu/GTCS

1. How to order EDQM products ► EDQM Store: www.edqm.eu/store ► E-mail: send your order as an attachment on your company letter headed paper to orders@edqm.eu

Please ensure your order clearly indicates:

► an invoicing address and a full delivery address (if different from the invoicing address; we do not deliver to P.O. Boxes) - EDQM publications ordered by a bookseller are sent to the bookseller address and not to the end user;

► a contact person for invoicing and for delivery, including their name, telephone number and E-mail address;

► the name, catalogue code and quantity for each item you wish to order.

2. Delivery time and Incoterms

Estimated delivery time is 7 working days from the date when the acknowledgement of receipt has been sent. Exception: controlled standards – up to 10 weeks after the reception of your import documents.

Orders are shipped either DAP, CIP or CPT depending on the item type.

3. Prices and payment terms

Find prices and availability under each product item at:

https://store.edqm.eu (Publications)

https://go.edqm.eu/crsdb (Ph. Eur. RS)

https://go.edqm.eu/isadb (WHO ISA RS)

https://go.edqm.eu/icrsdb (WHO ICRS)

Prices are given exclusive of duties and tax. It is your responsibility to contact your national fiscal or customs authorities to pay any duties and taxes due.

Booksellers receive a discount on publications. We do not grant any discount on reference standards.

Handling charges ► Publications: 20€ per volume (60€ per Ph. Eur. yearly subscription). These charges do not apply to orders placed on EDQM Store.

► Reference standards: 2.50€ per sales unit ordered.

Payment terms ► Payment in advance, or if a credit line has been authorised by the EDQM: full payment must be done within 30 days end of month.

► Payments can be made by credit card through the EDQM Store www.edqm.eu/store or by bank transfer.

Find complete information on order and dispatch of EDQM products:

https://go.edqm.eu/PDForder

Get in touch

Email: orders@edqm.eu

Telephone: + 33 3 88 41 30 30

Websites: www.edqm.eu and www.edqm.eu/store

Mailing address:

EDQM - COUNCIL OF EUROPESales Team 7 allée Kastner, CS 3002667000 Strasbourg – France

The Council of Europe is the continent’s leading human rights organisation. It comprises 47 member states, including all members of the European Union. All Council of Europe member states have signed up to the European Convention on Human Rights, a treaty designed to protect human rights, democracy and the rule of law. The European Court of Human Rights oversees the implementation of the Convention in the member states.

Direction européennede la qualité du médicament& soins de santé

European Directoratefor the Quality

of Medicines& HealthCare

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This publication presents an overview of Pharmacopoeia related products and services available in 2019 from the EDQM (European Directorate for the Quality of Medicines & HealthCare, Council of Europe).

www.edqm.eu