CRED SMPC 2024

6 December 2021 EMEA/29277/03 v.5 1 Human Medicines 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

IS Icelandic

CS Czech

IT Italian

DA Danish

LT Lithuanian

DE German

LV Latvian

EL Greek

MT Maltese

EN English

NL Dutch

ES Spanish

NO Norwegian

ET Estonian

PL Polish

FI Finnish

PT Portuguese

FR French

RO Romania

GA Irish

SK Slovak

HR Croatian

SL Slovenian

HU Hungarian

SV Swedish

1 Irish language added

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

Refer to www.ema.europa.eu/how-to-find-us

Address for visits and deliveries

Send us a question Go to www.ema.europa.eu/contact

Telephone +31 (0)88 781 6000

An agency of the European Union

© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.