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:
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)
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
- 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.