Notification Order Documents

IFA-Excel files and IFA-Forms

You may submit your notification orders to IFA GmbH using either excel order files (XLSX format) or PDF forms. Please fill in a complete order and send it by email to ifa@ifaffm.de. Further information on how and when notifying an order as well as explanations to each order type and attribute can be found in the IFA glossary and the guidelines IFA-Richtlinien zur Meldung von Artikel- und Adressdaten (in German only).

 

PZN Pre-Allocation – no Publication of the PZN
Before the actual launch of a product, you might need a PZN pre-allocation to use in your catalogue/brochure etc. You may amend the data of the pre-allocated PZN until its publication. Pre-allocations remain in its status for up to 2 years before returning to IFA GmbH. IFA GmbH may use the returned PZNs for its own purpose.

Notification using an excel file:
Auftragstabelle für PZN-Zuteilungen (ZU) // Excel order file for PZN pre-allocation

or Notification using a PDF form:
Anlage A - PZN-Zuteilung

No further documents are needed to receive a pre-allocation.

 

First Publication of Product Data – PZN publication in the IFA Information Services
Upon launch of the product on the German pharmaceutical market, you notify a first publication of product data into the IFA Information Services.

Notification of medicinal products, medical devices and other pharmacy-typical products using:
Auftragstabelle für Neuaufnahmen // Excel order file for PZN first publication
please include product information/Fachinformation (summary of product characteristics, SPC) and if applicable Zulassungsnachweis (marketing authorisation, MA)

or Notification of medicinal products using PDF form:
Anlage B1 – Neuaufnahme Arzneimittel
please include product information/Fachinformation (SPC) and if applicable Zulassungsnachweis (MA)

Notification of other pharmacy-typical products using PDF form:
Anlage B2 - Neuaufnahme sonstiger, apothekenüblicher Artikel
please include product information

Notification of medical devices using PDF form:
Anlage B3 - Neuaufnahme Medizinprodukt
please include product information and CE-Marking

 

NOTE

Each product must be notified with its product information/Fachinformation (SPC).

Usually a Zulassungsnachweis (MA) is only necessary if the marketing authorisation took place within the last six months.

For other pharmacy-typical products, an appropriate product information can be the following documents: a Packungsbeilage, brochure, photo of the outer packaging/label, list of product’s ingredients/INCIs.

 

 

Changing product data and product deletion
You may change or add product data of published PZNs, do a supplier change or delete the PZN. Changing product identifying characteristics (product name, package size, pharmaceutical form, attribute medicinal product, product type) cannot be done whilst retaining the PZN. These changes call for a new PZN for your product.

Notification of a product change using an excel file (not suitable for deletions):
Anforderung einer aktuellen EAD-Datei request the current EAD file

or Notification of a product change, deletion or supplier change using a PDF form:
Anlage C – Änderungen von Artikeldaten product changes PDF

For a supplier change, we need two release forms from either supplier stating the concerned PZN.

 

First publication and change in address data
Detailed information can be found in the new customer section on our website Neukunden.

Notification of address data change using an excel file:
Excel order file for address data

or Notification of address data change using PDF form:
Anlage D – Adressdaten 

For changing a company’s name, we need a current copy of the trade registry excerpt of the company.

 

NOTE

Before completion, save the forms locally on your computer drive by selecting "Save As ... ". To view and complete the PDF documents, Adobe Acrobat Reader DC is required which is available free of charge from the Adobe website Adobe Acrobat Reader DC.

 

 

IFA Codingsystem
SecurPharm
Informationsstelle für Arzneispezialitäten – IFA GmbH