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PHARMEUROPA Vol. 18, No.

4, October 2006 541


General Information
LIST OF STANDARD TERMS
5
th
EDITION
(27 European languages)
The present list of Standard Terms is a revised list that was drawn up in response to a request from the European
Commission. It covers medicines for both human and veterinary use. These Standard Terms are to be used in
answering the questions in Module 1 (items 1.2 and 1.3) of the EU application form.
The list of Standard Terms is composed of:
an introduction:
a section of general principles and instructions for the use of Standard Terms,
the summary of the changes (amendments, additions, deletions) performed since the last publication
(December 2002),
the procedure for the addition, deletion or modification of terms in the list of Standard Terms (requests
restricted to licensing authorities);
3 lists of standard terms:
list of pharmaceutical forms,
list of routes and/or methods of administration,
list of containers, closures and administration devices.
The 5
th
Edition contains translations in 27 European languages: Bulgarian, Croatian, Czech, Danish, Dutch, English,
Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Macedonian, Norwegian, Polish, Portuguese, Slovak,
Slovenian, Spanish, Swedish and Turkish. 5 new languages have been added compared to the printed version
published in December 2002: Estonian, Latvian, Lithuanian, Maltese and Romanian.
The corresponding online version is available only to those who ordered the printed version of the 5
th
Edition
(December 2004).
Price: see the catalogue on our website (http://book.pheur.org).
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LIST OF NEW STANDARD TERMS
The following new standard terms were adopted in May 2006 and have been included in the Standard Terms
database, accessible on our website (www.pheur.org). The translations have been included by the national
pharmacopoeia authorities.
Those who have already bought the printed version of the Standard Terms list (5
th
Edition, December 2004) can find
on the inside front cover the instructions to access the database.
NEW TERMS DEFINITIONS
Transdermal system Assembly of components intended for transdermal delivery driven by external forces
(e.g. electric current, chemical reaction). Transdermal patch is excluded.
Solution for skin-prick test Monograph No. 1063. Allergen product for diagnostic use
Solution for skin-scratch test Monograph No. 1063. Allergen product for diagnostic use
Solution for provocation test Monograph No. 1063. Allergen product for provocation test by the nasal, ocular or
bronchial route
Plaster for provocation test Monograph No. 1063. Allergen product for provocation test
Medicinal gas, compressed Gas packaged under pressure, which is entirely gaseous at - 50 C.
Medicinal gas, cryogenic Gas that liquefies at 1.013 bar at a temperature below - 150 C
Medicinal gas, liquefied Gas packaged under pressure, which is partially liquid (gas over a liquid) at - 50 C
Fixed cryogenic vessel Static, thermally insulated container designed to maintain the contents in the liquid
state
Mobile cryogenic vessel Mobile, thermally insulated container designed to maintain the contents in the liquid
state