Note: This document is a compilation of two EMEA documents: introductory text (file App III New Standards.pdf) and the specific guidance in English only (file App III Section 6.4 EN hum new); see also note below.

The European Agency for the Evaluation of Medicinal Products

London, January 2004
EMEA/29277/03/v1

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 1).

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 CPMP adopted a revision of this document in April 2003, which resulted in amendments of or additions to the required storage statements. The revised Note for Guidance came into effect on 31 October 2003.

Therefore all new marketing authorisation applications submitted to the EMEA after 1/10/2003, and also ongoing new applications for which a CPMP Opinion will be adopted after 1/1/2004 must include, in the SPC, Labelling and Package Leaflet, the new standard statements listed in this Appendix.

Mainly for the purpose of the ongoing pre-accession linguistic review, the old statements can still be found in this appendix for all the EU languages and also for the new accession countries languages.

Note: WHO inserted comment: In this version supporting the development of WHOPARs in English, the English version of the document is presented below; all other EU versions are available on the EMEA website.

For all products that are already authorised, the product information will have to be updated according to this Note for Guidance in a future suitable line extension, variation or renewal application, following discussion with the EMEA.

SUMMARY OF PRODUCT CHARACTERISTICS

6.4 Special precautions for storage

<Do not store above <25°C> <30°C>> or
<Store below <25°C> <30°C>>
<Store in a refrigerator (2°C - 8°C)>
<Store and transport refrigerated (2°C - 8°C)>*
<Store in a freezer {temperature range}>
<Store and transport frozen {temperature range}>**
<Do not <refrigerate> <or> <freeze>>
<Store in the original <package>>
<Keep the {container}*** tightly closed>
<Keep the {container}*** in the outer carton>
<This medicinal product does not require any special storage conditions>

<in order to protect from <light> <moisture>>

A. LABELLING

<Do not store above <25°C> <30°C>> or
<Store below <25°C> <30°C>>
<Store in a refrigerator>
<Store and transport refrigerated>*
<Store in a freezer>
<Store and transport frozen>**
<Do not <refrigerate> <or> <freeze>>
<Store in the original <package>>
<Keep the {container}*** tightly closed>
<Keep the {container}*** in the outer carton>
<in order to protect from <light> <moisture>>

B. PACKAGE LEAFLET

5. STORING X

Keep out of the reach and sight of children.

<Do not store above <25°C> <30°C>> or
<Store below <25°C> <30°C>>
<Store in a refrigerator (2°C - 8°C)
<Store and transport refrigerated (2°C - 8°C)>*
<Store in a freezer {temperature range}>
<Store and transport frozen {temperature range}>**
<Do not <refrigerate> <or> <freeze>>
<Store in the original <package>>
<Keep the {container}*** in the outer carton>
<Keep the {container}*** tightly closed>
<This medicinal product does not require any special storage conditions>
<in order to protect from <light> <moisture>>

Do not use after the expiry date stated on the <label> <carton> <bottle> <...>

<Do not use X if you notice {description of the visible signs of deterioration}>

* The stability data generated at 25°C/60%RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary. The statement should only be used in exceptional cases.

** The statement should be used only when critical.

*** The actual name of the container should be used (e.g. bottle, blister, etc.)