The QP must always certify / release a batch according to the dossier valid at the time. In principle, for Type IB and Type II variations (human) or Variations requiring assessment (VRA, veterinary), the date of BASG approval ("Approval Date") is the date of the dossier variation ("Implementation Date"). If no further information is submitted by the marketing authorisation holder, batches must be certified/released in accordance with the new dossier from the date of approval by the BASG.
In the eAF, however, it is also possible to specify an implementation date in the future (either as a fixed date e.g. "from 1.5. 2023" or as a time period after the date of approval by the BASG e.g. "two months from the date of approval by the BASG"). In this case, the change in the dossier takes place with the implementation date in the future and the QP can certify / release according to the old dossier until this implementation date. As of the implementation date in the future or after the expiry of the period following the date of approval by the BASG, the QP may only certify / release according to the amended, new dossier.
As an alternative to the eAF, an implementation date in the future can also be specified in the cover letter.
It is noted that a changeover of the QP release to the modified (new) dossier can also take place before the implementation date in the future (e.g. implementation date would be 1.5.2023; however, the company-internal changes are already completed on 1.4.2023. The batch to be certified / released on 15.4.2023 should already be done according to the amended dossier). As a result, the new dossier becomes valid on this date and batches may no longer be certified/released according to the old dossier. Switching back and forth between the old and the new dossier is not possible.
How should batches that have already been released be handled?
Products that have already been certified / released by the QP according to the "old dossier" before the implementation date may be placed on the market after the implementation date; the corresponding deadlines according to AMG §25a AMG must be observed.