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Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products: updated version of document is published

20.07.2017.
 

Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products: updated version of document is published

 The State Agency of Medicines (SAM) informs that the most recent version of Appendix IV Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products (PDF) is published on the European Medicines Agency (EMA) website.

The footnotes 1 and 2 limiting the use of the abbreviations Lot un EXP have been omitted. The abbreviations Lot un EXP may now also be used on the outer packaging.

Changes to the product information regarding the expression of “batch number” and “expiry date” can be included within the scope of any another planned variation that affects the relevant product information or they can be submitted using a single variation (IA / “changes in package leaflet or labelling that are not related to changes in the summary of product characteristics” or IB / C.I.z).

Please note that the information regarding to the expression of “expiry date” should be harmonized both in the labelling and in the package leaflet (for details see the annotated product information template on the Heads of Medicines Agencies HMA website).