FAQ
The following FAQ (Frequently Asked Questions) consist of recurring questions to IFA GmbH. They are grouped under a topic and followed by their answer. If your question is not mentioned, please do not hesitate to contact us directly.
The desired change affects one of the so-called artikelidentifizierendes Merkmal (product identifying characteric): Produktbezeichnung, Darreichungsform, Packungsgröße, Artikeltyp and the attribute Arzneimittel.
For the PZN to remain uniquely identifiable for the market participants at any time, product identifying characteristics must not be changed for published PZNs (cf Richtlinien für die Zuteilung von Pharmazentralnummern). In this case, a new PZN must be published.
Ärztemuster according to article 96 of the regulation 2001/83/EG must bear the security features according delegated act (EU) 2016/161 (article 2 and 41).
A frequent question is how the samples need to be treated. The pharmaceutical entrepreneur creates a serial number during the packaging process and uploads it into the European HUB. Before the pack is dispensed to a doctor, the pharmaceutical entrepreneur deactivates the serial number. Thus making sure that the pack may not be dispensed elsewehere. The PZN can remain the same for packs being used as physician samples during the production process. For packs that are used as physician samples exclusively, a PZN must be allocated.
No, Ärztemuster cannot be ordered by pharmacies or pharmaceutical wholesalers.
In general, notifying physician samples is not treated differently to medicinal products of the type standard. The following documents have to be submitted:
- Fachinformation (SPC)
- Proof of MA / registration
- completely filled in excel file Auftragstabelle für Neuaufnahmen
The following entries differ from a medicinal product with the product type standard:
- Artikeltyp: Ärztemuster gemäß AMG
- Preisinformationen: no entries; without VAT
- Packungsgrößenverordnung (PackungsV): nicht betroffen
- all Vertriebswege: nein
The PNR is the number of the pharmaceutical entrepreneur assigned to the entrepreneur upon its first application by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
It is used in IFA's Information Services within the scope of implementing the FMD. The PNR must only be notified to IFA GmbH if the supplier is not the pharmaceutical entrepreneur according to AMG. To submit the PNR with the address data of the pharmaceutical entrepreneur (address of the legal entiry) and add it to the PZN in concern, please email the PNR to ifa@ifaffm.de. The PNR will be transmitted to ACS PharmaProtect GmbH exclusively with IFA's Information Services.
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