15 June 2019

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EMA/286379/2019 rev. 12
Scientific & Regulatory Management

Appendix IV
TERMS/ABBREVIATIONS FOR “BATCH NUMBER” AND “EXPIRY DATE” TO BE USED ON THE LABELLING OF HUMAN
MEDICINAL PRODUCTS

Full Term EN BG CS DA6 DE7 EL ES7 ET FI6 FR HR6 HU IT

batch Lot 1 Lot Lot 1 Lot 1 Lot Lot Lot Lot Lot 1
Lot Lot Lot Lot
number
Batch Партида: č.š.: Batch Ch.-B. Παρτίδα Lote Partii nr: Batch Broj serije Batch Lotto
BN Партиден № Č. šarže Erä Serija Gy.sz.:

Парт.№

expiry date EXP 1 EXP 5 1 EXP 1 EXP EXP EXP 5 EXP 1

EXP EXP EXP EXP EXP EXP

Годен до: Použitelné do: Anvendes inden verwendbar ΛΗΞΗ CAD Kõlblik Käyt. Rok Felhasz Scad.
bis kuni: viim. valjanosti nálható:
Anv. inden
1 1
verw.bis Felh.:
Anvendes før

Udløbsdato

#
Changes since the last revision: Footnotes revised for LT

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

Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
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, 2019. Reproduction is authorised provided the source is acknowledged.
Full Term EN IS6 LT6 LV6 MT NL NO6 PL PT RO SK SL6 SV6
8 3
batch Lot Lot Lot Lot Lot Lot Lot Lot Lot Lot Lot Lot Lot
number
Batch Lotunr. Serija Sērija LOTT Batch Batch Nr serii Lote Serie Č. šarže Številka Batch

4 serije
BN Sēr. Partij Nr serii (Lot) Sats

Charge

5, 8 5 3
expiry date EXP EXP EXP EXP EXP EXP EXP EXP EXP EXP EXP EXP EXP

Fyrnist Tinka iki Derīgs līdz JIS Utløpsdato Termin ważności VAL Data Dátum Uporabno do Utg.dat.
expirării exspirácie
Der.līdz Utl.dato Termin ważności
4
(EXP)

1
Accepted for small immediate packaging and blisters only
2
Accepted for all types of immediate packaging only in case of multilingual packs
3
Accepted for all types of immediate packaging only if “Nr serii (Lot)” or “Termin ważności (EXP)” is used on the outer labelling
4
Accepted for the outer labelling only when “Lot” or “EXP” is used on the inner labelling
5
Accepted for the outer labelling only when the meaning of “EXP” is explained in the package leaflet
6
For small immediate packaging and blisters, the batch number and the expiry date can be stated without any words or abbreviations
7
For blisters, the batch number and the expiry date can be stated without any words or abbreviations
8
Accepted for small immediate packaging, blisters, multilingual packs and packs containing safety features only

For the Belgium trilingual pack, EXP and Lot are accepted for all types of packaging

Appendix IV
EMA/286379/2019 Page 2/2