STANDARD TERMS
Standard Terms Database
The lists of Standard Terms were drawn up in response to a request from the European Commission, and cover dosage forms, routes and/or methods of administration, and containers, closures and delivery devices used for medicines for human and for veterinary use. They give the equivalents of several hundred terms in 32 world languages: Albanian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, Portuguese, Romanian, Serbian, Slovak, Slovene, Spanish, Swedish, Turkish and Ukrainian.
The Standard Terms are used in European Marketing Authorisation applications, the Summary of Product Characteristics (SmPC), labelling and electronic communications.
The database also provides a summary of changes made to the lists on given dates, recent decision taken by the Standard Terms Working Party and the European Pharmacopoeia Commission, and an explanation of the different statuses of the terms.
The Standard Terms Introduction and Guidance for Use details the general principles and instructions for use of the lists of terms, and the Change Request Form outlines the procedure to be followed for requesting additions and modification (requests to the EDQM are restricted to national European licensing or pharmacopoeia authorities, the EMA and the EU Commission).
Since 28 April 2008 the EDQM has only been selling an online version. Customers purchasing the online version are provided with an EPID reference to gain access to the database. Information on how to register an EPID Code can be found on the right of this page.
The online version is also available FREE to customers who purchased the last printed version of Standard Terms (5th Edition 2004). To gain access to the online version the EPID code on the inside-front cover of the printed version is used.
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Important information
06 May 2013
The EDQM Store gets a facelift!
The EDQM begins to roll out its completely redesigned EDQM Store.
Read all about the changes in the new Store
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Standard Terms is accessible to our partners and customers who have previously purchased the print version of this publication and those who have bought the new online access product. For online access, please click on Online Publications.
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EDQM Council of Europe
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F67081 Strasbourg, France
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Fax +33 (0)3 88 41 27 71
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