European Pharmacopoeia (Ph. Eur.) 9th Edition (July 2016) + Supplement 9.1 (October 2016) + Supplement 9.2 (January 2017), ISBN: 9789287181336, Book Version: Language: English

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European Pharmacopoeia (Ph. Eur.) 9th Edition (July 2016) + Supplement 9.1 (October 2016) + Supplement 9.2 (January 2017), ISBN: 9789287181336, Book Version: Language: English

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Product Details

European Pharmacopoeia 9th edition - English Print (9.0 to 9.2 - Print 9th Edition 2017) - English

The subscription contains 3 issues in English:

Main volume 9.0 published in July 2016,
Supplement 9.1 published in October 2016 and
Supplement 9.2 published in January 2017.
Author: European Pharmacopoeia Commission, Council of Europe European Directorate for the Quality of Medicines (EDQM)
Publisher: EDQM; 9th edition (2017)
Language: English
ISBN-10: 9287181330
ISBN-13: 978-9287181336
Shipping Weight: 8.000 KG
Reference: PUB200211
Hardcover


Description

 

The 9th Edition of the European Pharmacopoeia (EP), main volume and supplements, is legally binding and details the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, the raw materials used in the production of medicines and on the intermediates of synthesis.

The EP is a single reference work for the quality control of medicines in Europe. All producers of medicines or substances for pharmaceutical use must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe.

Key features

Applicable in 37 European countries and used in over 100 worldwide

Delivers crucial information earlier than any other Pharmacopoeia

Over 50% new or revised texts compared to the 8th Edition

European Pharmacopoeia (Ph. Eur.) 9th Edition

Essential to market your products in Europe, and beyond

The European Pharmacopoeia (Ph. Eur.) is Europe’s legal and scientific benchmark for pharmacopoeial standards which contribute to delivering high quality medicines in Europe and beyond.

The Ph. Eur. is applicable in 38 European countries and used in over 100 countries worldwide.

It delivers crucial information earlier than any other pharmacopoeia – the 9th Edition was released in mid-2016.

With 121 new and 1,403 revised texts, over 50% of the 9th Edition’s content is new compared to the 8th Edition.


European Pharmacopoeia: Versions and Subscriptions


The Ph. Eur. is supplied in a variety of formats:

    Book Version: Available in English or French. The 9th Edition consists of 3 initial volumes (9.0) and they will be complemented by 8 non-cumulative supplements (9.1 to 9.8). The 9th Edition (including Supplement 9.8) contains 2406 monographs (including dosage forms), 365 general texts (including general monographs and methods of analysis) and around 2730 descriptions of reagents.  A direct link to the KNOWLEDGE database is included from each monograph. Free access to online archives.

    Online Version: Completely cumulative, tablet and smartphone friendly. Bilingual: English and French. Changes (inserted or deleted texts) indicated in both html and pdf versions. Possibility of adding RSS feeds for specific queries. Direct access to the KNOWLEDGE database, with a powerful search engine.  Read the Technical Specifications
    Downloadable version:  Completely cumulative and bilingual (English and French). Allows easy access to the Ph. Eur. while on the move or in environments where the use of the book or online version would be inappropriate or impractical. It is also ideal for users who have more than one computer. Starting with Supplement 9.3, the Download version replaces the USB version.
     
    The 2019 subscription will consist of three links to the content of supplements 9.6, 9.7 and 9.8 respectively, which may be downloaded
    - and installed on a computer
    - and/or copied to a USB stick to be activated and run from any PC without installation.

    Read our FAQs for more information and technical support.
    Languages: The book version is available in English and French. The online, USB and Downloadable versions are bilingual (English and French).
    Packages: Different packages are available for a significantly reduced price for customers interested in having more than one version.
    Archives: The Ph. Eur. Archives contain the 1st Edition to the 8th Edition in PDF format. The archives are available to those who have a subscription (book, online, USB or downloadable) and a registered EPID code.


The European Pharmacopoeia is a single reference work for the quality control of medicines in the signatory states of the Convention on its elaboration.

The official standards published within provide a legal and scientific basis for quality control during the development, production and marketing processes.

They concern the qualitative and quantitative composition and the tests to be carried out on medicines, on the raw materials used in production of medicines and on the intermediates of synthesis. All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards in order to market their products in the signatory states of the Convention.
 
Legal Framework

Several legal texts make the European Pharmacopoeia mandatory. These are as follows:

    the Convention developed by the Council of Europe on the Elaboration of a European Pharmacopoeia,
    a Protocol adopted in 1994 and amending the Convention to prepare for the accession of the European Union and defining the respective powers of the European Union and its member states within the European Pharmacopoeia Commission,
    European Union Directives 2001/83/EC and 2001/82/EC, as amended, on medicines for human and veterinary use. These maintain the mandatory character of European Pharmacopoeia monographs when requesting marketing authorisation (MA).

The contracting parties of the Convention undertake to:

    progressively elaborate a Pharmacopoeia which shall become common to the countries concerned and which shall be entitled "European Pharmacopoeia"
    take the necessary measures to ensure that the monographs shall become the official standards applicable within their country by direct implementation in the national legislation or by indirect implementation through national translation.

For information about the working procedure and the functions of the different bodies responsible for carrying out the work of elaborating a European Pharmacopoeia, please consult the documents in the right-hand menu.
 
Mission

The purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. Such standards are to be appropriate as a basis for the safe use of medicines by patients. In addition, their existence facilitates the free movement of medicinal products in Europe and beyond.

European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of:

    regulatory authorities;
    those engaged in the quality control of medicinal products and their constituents;
    manufacturers of medicinal products and their individual components.

The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.

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