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

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 1, 2019