First Publication of Product Data

Upon launch of the product on the German pharmaceutical market, you notify a first publication of product data into the IFA Information Services.

Required order documents and further information by type of product:

Medicinal Product

IFA-Auftragstabelle B1 – First Publication Medicinal Product or
Anlage B1 – PZN First Publication Medicinal Product
Please include Summary of Product Characteristics (SPC) and if applicable Marketing Authorisation (MA)

Medicinal Device

IFA-Auftragstabelle B3 – First Publication Medical Device or
Anlage B3 – PZN First Publication Medical Device
Please include product information and CE marking

Other pharmacy-typical Product

IFA-Auftragstabelle B2 – First Publication Other Product or
Anlage B2 – PZN First Publication Other Product
Please include product information

All Types of Products

IFA-Auftragstabelle B – PZN First Publication
Please include Summary of Product Characteristics (SPC), Marketing Authorisation (MA) if applicable, product information and  CE marking if applicable

Hint

  • Each product must be notified with its product information or SPC.
  • 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.
  • Usually a Zulassungsnachweis (MA) is only necessary if the marketing authorisation took place within the last six months.
Note

Use of forms 

To view and complete the PDF documents, Adobe Acrobat Reader DC is required which is available free of charge from the Adobe website.

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