WHOPAR Guidance for Applicants
(2004; 140 pages)
Índice de contenido
Ver el documentoGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
Ver el documentoAppendix 1 - Characteristics of WHOPAR Parts
Ver el documentoAppendix 2 - Documentation to submit together with the initial submission
Cerrar esta carpetaAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
Ver el documentoANNEX I - Summary of product characteristics - Word Templates
Ver el documentoANNEX III - Labelling and package leaflet - Word Templates
Ver el documentoANNEX I - Summary of product characteristics - annotated
Ver el documentoANNEX III - Labelling and package leaflet
Ver el documentoAPPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC
Ver el documentoAPPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC
Ver el documentoAPPENDIX III - Standards for required storage standards
Ver el documentoAPPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling
Ver el documentoConvention to be followed for EMEA-QRD templates
Ver el documentoCompilation of QRD decisions on the use of terms
Ver el documentoCompilation of QRD decisions on stylistic matters in product information
Ver el documentoTables of non-standard abbreviations
Ver el documentoAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

APPENDIX III - Standards for required storage standards

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.

ENGLISH

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

9. SPECIAL STORAGE CONDITIONS

 

<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.)

 

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