FAQ

The verification information Verifizierungspflicht gemäß Fälschungsschutzrichtlinie – Verification mandatory according to Falsified Medicines Directive and Verifiz Pflicht ab Verfall – Verification mandatory from expiry date onward in the IFA database is used to identify medicinal products obliged to verification.

For first publication of new medicinal products obliged to verification, a corresponding entry must be notified in the data field Verifizierungspflicht gemäß Fälschungsschutzrichtlinie – Verification mandatory according to Falsified Medicines Directive.

In the rare cases when medicinal products first become obliged to verification as a result of a change in legal requirements, in addition to marking the Verification mandatory according to Falsified Medicines Directive data field, the expiry date of the first batch subject to mandatory verification must be notified in the data field Verifiz Pflicht ab Verfall – Verification mandatory from expiry date onward. 

Generally, IFA GmbH transfers datas of PZN obliged to FMD when first publication happens at the time of their launch to ACS PharmaProtect GmbH. If the notification is done without a blocking period, data will be transferred 10 working days prior to the publication data (with blocking period: 5 working days). Only after a PZN has been announced in the ACS system it is possible to upload serial numbers.

If a longer timeframe is requested for uploading the serial numbers, an unpublished PZN (PZN pre-allocation) may be applied for in advance, and IFA GmbH may be instructed to forward this to ACS. Such a PZN pre-allocation is announced to ACS PharmaProtect GmbH 10 working days before the next publication date. Irrespective of this, requests for the first publication of the PZN in the IFA information services must be submitted as before.