WHOPAR Guidance for Applicants
(2004; 140 pages)
Table des matières
Afficher le documentGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
Afficher le documentAppendix 1 - Characteristics of WHOPAR Parts
Afficher le documentAppendix 2 - Documentation to submit together with the initial submission
Fermer ce répertoireAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
Afficher le documentANNEX I - Summary of product characteristics - Word Templates
Afficher le documentANNEX III - Labelling and package leaflet - Word Templates
Afficher le documentANNEX I - Summary of product characteristics - annotated
Afficher le documentANNEX III - Labelling and package leaflet
Afficher le documentAPPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC
Afficher le documentAPPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC
Afficher le documentAPPENDIX III - Standards for required storage standards
Afficher le documentAPPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling
Afficher le documentConvention to be followed for EMEA-QRD templates
Afficher le documentCompilation of QRD decisions on the use of terms
Afficher le documentCompilation of QRD decisions on stylistic matters in product information
Afficher le documentTables of non-standard abbreviations
Afficher le documentAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

APPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling

European Agency

Version 07/2004

FULL TERM

EN

DA

DE**

EL

ES

FI

FR

IT

NL

PT

SV

NO

IS

 

Batch

             

Partij

       

batch number

Lot BN

Batch Lot

CH.-B.: Lot*

Παρτια

Lote Lot*

Erä Lot

Lot

Lotto Lot

Charge Batch Lot

Lote

Sats Batch Lot

Batch Lot

Lotunr. Lot

expiry date

EXP

udløbsdato EXP

Verwendbar bis Verw.bis* EXP*

ΛΗΞΗ

CAD EXP*

Käyt. viim. EXP.

EXP

Scad. EXP*

EXP

VAL. EXP

Utg.dat EXP

Utløpsdato Anv. Senest EXP*

Fyrnist EXP

FULL TERM

EN

CS

ET

HU

LV**

LT**

MT

PL

SK

SL

batch number

Batch Lot BN

č.š.: Lot*

Partii nr: Lot***

Gy.sz.: Batch Lot

Sērija Sēr. Lot*

Ser. Nr. Serija Partija Lot*

LOTT Lot

Nr serii Nr serii (Lot)**** Lot*

Č. Šarže

Serija Batch Lot

expiry date

EXP

Použitelné do: EXP

Kõlblik kuni:** EXP***

Felhasználható: Felh.:* EXP

Derīgs līdz Der.līdz EXP*

Tinka iki EXP*

JIS EXP

Termin ważnoœci Termin ważnoœci (EXP)**** EXP*

Dátum exspirácie EXP

Uporabno do Upor. do* EXP

* Small immediate packaging only

** On blisters (immediate packaging) the date can be stated without any words

*** Also acceptable for the outer labelling in case of multilingual packs.

**** For the outer labelling only, when "Lot" or "EXP" is used on the inner labelling.

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