Important: Expiry dates printed on packs
We would like to draw your attention to an issue that is not directly related to FiMVS but does nevertheless affect some users of the system and the patients/consumers. The issue is expiry dates: how they are uploaded in FiMVS, encoded in the 2D data matrices, and printed in human readable format on the packs. As a rule, the expiry date uploaded in FiMVS should be identical to the expiry date encoded in the 2D data matrix AND the expiry date printed in human readable format on packs.
We have observed that for some products and batches, the expiry date uploaded in FiMVS is not the last day of the month but may be any given day on that month. This same expiry date is also encoded in the 2D data matrix on the packs. However, in human readable format the expiry date printed on the packs typically states only month and year, with the exception of e.g. certain advanced therapy medicinal products. This poses a problem as the expiry date printed on the pack stating only month and year should be taken to mean the last day of that month.
For example, the expiry date uploaded in FiMVS and encoded in the 2D data matrix may be 02-Nov-2024 but in human readable format it has been printed as Nov 2024 or 11-2024, which means 30-Nov-2024.
This discrepancy does not impact the verification or decommissioning of the pack, i.e. the pack can only be decommissioned until the expiry date uploaded in FiMVS and encoded in the 2D data matrix but not after this date. The issue may, however, lead to the situation that patients may inadvertently take expired medications or they may be administered expired medications in hospitals or nursing homes. The reason is that in these cases the pack has been decommissioned at an earlier point of time and the expiry date printed on the pack exceeds the actual expiry date of the corresponding batch. Furthermore, we have received feedback that some end users find this discrepancy confusing as they are not sure which is the correct expiry date of a pack, the one encoded in the 2D data matrix or the one printed on the pack in human readable format.
In the light of the above, we urge all OBPs/MAHs to calculate the expiry dates of batches as the last day of the month. In the previous example, if we assume that the approved shelf life of the product is 3 years and the manufacturing of the batch began on 02-Nov-2021, the calculated expiry date of the batch would be 31-Oct-2024. This should be uploaded in FiMVS and encoded in the 2D data matrix as 241031 or 241000 and printed in human readable format e.g. as Oct 2024 or 10-2024.