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Appendix IV - Terms and abbreviations for batch …

30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 11 July 2017 EMA/424591/2017 rev. 11# 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 number Lot batch BN Lot1 Партида: Партиден No Парт.No Lot ..: . ar e Lot batch Lot1 Lot Lot1 Lote Lot Partii nr: Lot batch Er Lot Lot Broj serije Serija Lot batch : Lot1 Lotto expiry date EXP EXP1 Годен до: EXP Pou iteln do: EXP5 Anvendes inden Anv.

Title: Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products Author: European Medicines Agency

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Transcription of Appendix IV - Terms and abbreviations for batch …

1 30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 11 July 2017 EMA/424591/2017 rev. 11# 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 number Lot batch BN Lot1 Партида: Партиден No Парт.No Lot ..: . ar e Lot batch Lot1 Lot Lot1 Lote Lot Partii nr: Lot batch Er Lot Lot Broj serije Serija Lot batch : Lot1 Lotto expiry date EXP EXP1 Годен до: EXP Pou iteln do: EXP5 Anvendes inden Anv.

2 Inden Anvendes f r Udl bsdato EXP1 verwendbar bis EXP EXP1 CAD EXP K lblik kuni: EXP K yt. viim. EXP EXP5 Rok valjanosti EXP Felhaszn lhat : Felh.:1 EXP 1 Scad. #Changes since the last revision: Footnotes revised for HR and LV Appendix IV EMA/424591/2017 Page 2/2 Full Term EN IS6 LT6 LV6 MT NL NO6 PL PT RO SK SL6 SV6 batch number Lot batch BN Lot Lotunr. Lot1 Serija Lot S rija S r. Lot LOTT Lot batch Partij Charge Lot batch Lot3 Nr serii Nr serii (Lot)4 Lot Lote Lot Serie Lot . ar e Lot tevilka serije Lot batch Sats expiry date EXP EXP Fyrnist EXP1 Tinka iki EXP Der gs l dz dz EXP JIS EXP EXP5 Utl psdato EXP3 Termin wa no ci Termin wa no ci (EXP)4 EXP VAL EXP Data expir rii EXP D tum exspir cie EXP Uporabno do 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 wa no ci (EXP)

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


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