WHOPAR Guidance for Applicants: Appendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling: APPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling

Table des matières

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

European Agency

Version 07/2004

FULL TERM

DE**

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.