3 February 2016

EMEA/29277/2003 v.4
Human Medicines Evaluation Division

Appendix III to the QRD templates for human medicinal

products

This appendix should be read together with the Note for Guidance on the Declaration of Storage
Conditions A) in the product information of medicinal products, and B) for active substances
(EMEA/CPMP/QWP/609/96/Rev 2).

The purpose of the Note for Guidance is to set out uniform statements on storage conditions for
inclusion in the product information of medicinal products and labelling of active substances and to
define when they apply. The CHMP adopted a revision of this document in November 2007, which
resulted in amendments of/or additions to the required storage statements.

Storage Conditions

BG Bulgaria IT Italian

CS Czech LT Lithuanian

DA Danish LV Latvian

DE German MT Maltese

EL Greek NL Dutch

EN English NO Norwegian

ES Spanish PL Polish

ET Estonian PT Portuguese

FI Finnish RO Romania

FR French SK Slovak

HR Croatian SL Slovenian

HU Hungarian SV Swedish

IS Icelandic

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