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
Please include Summary of Product Characteristics (SmPC) and Marketing Authorisation (MA) – AMIce extract preferred
Medicinal Device
IFA-Auftragstabelle B3 – First Publication Medical Device
Please include product information and CE marking
Other pharmacy-typical Product
IFA-Auftragstabelle B2 – First Publication Other Product
Please include product information
Hint
- Depending on the type of product, the following documents must be enclosed with the order:
-
Medicinal products: Summary of product characteristics, extract from Medicinal Products Information System AMIce (or similar proof of marketing authorisation, marketing authorisation no., BfArM processing number (ENR))
-
Medical devices: Label and package leaflet with CE mark
-
Other pharmacy-typical products: Label and package leaflet
-
- For other pharmacy-typical products, an appropriate product information can be the following documents: Label and package leaflet, brochure, photo of the outer packaging / label, list of product’s ingredients / INCIs.
Document Finder