Certification of Substances Division
SHE/CB
PUBLIC DOCUMENT
(LEVEL 1)
English only/Anglais seulement
PA/PH/CEP (12) 112
Strasbourg, December 2012
Certification of suitability to Monographs of the European Pharmacopoeia
Definition section of Ph. Eur. Monographs and CEPs
Address: 7, allée Kastner, CS 30026
F - 67081 Strasbourg (France)
Telephone: 33 (0) 3 88 41 30 30 - Fax: 33 (0) 3 88 41 27 71 - e-mail: [email protected]
Internet : http://www.edqm.eu
EDQM
Certification of Substances Division
PA/PH/CEP (12) 112
ENGLISH
According to the European Pharmacopoeia, any statements included under the heading
“Definition” of the monograph constitute an official definition of the substance which is the
subject of the monograph.
In these cases, any substance, for which the mode of preparation is not in line with the
requirements of the Definition Section of the related monograph, falls outside the scope of
the procedure for Certification of Suitability to the Monograph of the European
Pharmacopoeia.
The EDQM will therefore no longer accept (effective 2 January 2013) any new application
for CEPs for which the mode of preparation of the substance is not in line with the
requirements of the Definition Section of the related monograph.
For example, if the Definition Section of the monograph states “Semi-synthetic product
derived from a fermentation product” and the substance in question is manufactured by a
purely synthetic process then a new application for a CEP will not be accepted.
Existing CEPs and on-going applications are not affected by this decision.
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