FAQ

The two attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum in the IFA database help to determine medicinal products obliged to verification and to rule out so-called Bestandsware released packs for the market before the deadline 09.02.2019. Thus these attributes determine the unhindered release of Bestandsware.

Bestandsware (released prior to 09.02.2019) may have three versions:

• Type 1: without security features, thus no anti-temper device and no distinctive feature
• Type 2: with security features but without upload of data into PU system; serial numbers are unknown to the system
• Type 3: with security features and upload of data into PU system; the pack is FMD compliant

Both attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum must be notified to IFA GmbH for medicinal products obliged to verification. They are used to determine medicinal products' packs obliged to verification and rule out so-called Bestandsware (released packs from 09.02.2019).

With the attribute Verifizierung im Pflichtbetrieb ab Hochladedatum the pharmaceutical entrepreneur determins the medicinal product's obligation to verification. The pharmaceutical entrepreneur notifies the date of the first upload of packs obliged to verifications' serial numbers into the PU system. Typically this is the deadline 09.02.2019.

Per PZN this notification must be done once even if logically over time more and more serial numbers are uploaded into the PU system.

Information on how the notification should be done can be found in the FAQ:
How do I notify the attributes 'Verifizierung im Pflichtbetrieb ab Hochladedatum' and 'Verifizierung im Pflichtbetrieb ab Verfalldatum' for new publications after 15.02.2019?

The attribute Verifizierung im Pflichtbetrieb ab Verfalldatum depicts the shelf life of the first batch obliged to verification. It is used to distinguish dispensable so-called Bestandsware from packs obliged to verification.

If the expiry date in the pack's Data Matrix Code is before the notified date, Bestandsware is expected. If in doubt, the pharmaceutical entrepreneur notifies the latest possible expiry date: this is the deadline 09.02.2019 plus the medicinal product's shelf life added on top.

Information on how the notification should be done can be found in the FAQ:
How do I notify the attributes 'Verifizierung im Pflichtbetrieb ab Hochladedatum' and 'Verifizierung im Pflichtbetrieb ab Verfalldatum' for new publications after 15.02.2019?

First publications from 15.02.2019 have to if they:

1. were released by the pharmcaceutical entrepreneur / supplier from 09.02.2019 onwards and
2. are affected by the FMD, thus obliged to verification,

be produced FMD-compliant. I. e. packs bear the DMC according to the FMD. In those cases there is no Bestandsware. For those packs the verification attributes are to be notified as follows:

Attribute Verifizierung im Pflichtbetrieb ab Hochladedatum:
You will notify the deadline date of the FMD, 09.02.2019, because the reference to the deadline remains the same.
Thus the pharmaceutical entrepreneur / supplier determins the medicinal product as obliged to verification. All data uploads will be treated as obliged to verification by the so-called PU system.

Attribute Verifizierung im Pflichtbetrieb ab Verfalldatum:
By notifying this attribute, the pharmaceutical entrepreneur / supplier has the opportunity to prevent a third party from marketing non FMD compliant products suggesting that it would be Bestandsware. Thus the the pharmaceutical entrepreneur / supplier has to notify a date before the one stated on the DMC respectively affixed to the first batch's pack. I. e. the date 022019 can be notified.

EXCEPTION:
An exception is a first publication from 15.02.2019 onwards with the products already released by the pharmaceutical entrepreneur / supplier before 09.02.2019. I. e. you notify first publications of Bestandsware. The batches being released after 09.02.2019 must be produced FMD-compliant, bear a DMC. For those packs the attributes are to be notified as follows:

Attribute Verifizierung im Pflichtbetrieb ab Hochladedatum:
The pharmaceutical entrepreneur will notify the upload date of FMD-compliant serial numbers into the EU hub. I. e. the date may be after the 09.02.2019.  

Attribute Verifizierung im Pflichtbetrieb ab Verfalldatum:
The highest possible entry for this attirbute is the deadline date 09.02.2019 plus the shelf life of the affected medicinal product.

If the supplier fails to notify the attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum, logic check system processes in the market will act according to the data notified by the supplier. Incorrect or incomplete notifications may lead to packs that would be dispensable not being recognized as such and thus will not be dispensed. Notifying the above mentioned attributes is vital.

Yes, if it is actual Bestandsware released to the market prior to the 09.02.2019. For the systems to identify these packs as Bestandsware, the pharmaceutical entrepreneur must notify the attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum.

The attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum are used to identify medicinal products obliged to verification as well as to distinguish these from the so-called Bestandsware, packs released prior to 09.02.2019. Thus these attributes aid the dispense of Bestandsware.

Generally, IFA GmbH transfers datas of PZN obliged to FMD at the time of their launch and first publication to ACS PharmaProtect GmbH. If the notification is done without a blocking period, data will be transfered 10 working days prior to the publication data (with blocking period: 5 working days). Serial numbers may only be uploaded into ACS's system after their knowledge of the PZN.

If you need more time to upload serial numbers, you may, upon PZN pre-allocation, ask IFA GmbH to transfer the data to ACS. A PZN pre-allocation will be transferred 10 working days prior to the next possible publication date to ACS PharmaProtect GmbH. Note: you will have to notify the PZN's first publication with IFA GmbH for the desired publication date in order to publish the data in IFA's information services.

PNR (Nummer des Pharmazeutischen Unternehmers - number of the pharmaceutical entrepreneur, assigned by BfArM) is used for internal purposes in relation to implementing the FMD. It is not issued as part of the IFA Information Services.