FAQ

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 product type standard. The following product information/proofs have to be submitted:

• Summary of product characteristics (SmPC)
• Proof of MA – proof of registration (excerpt from AMIce database preferred)
  

   

The following notification channels are available:

• IFA portal
• IFA-Auftragstabelle B1 – First Publication Medicinal Product
  

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