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 Marketing Authorisation (MA)
Please use one of the order documents listed below (either Excel Order File D2 or Form D2) for the notification of product-related address data (e.g. marketing authorisation holder or local representative):
IFA-Auftragstabelle D2 – Product-related Address Data or
Anlage D2 – Product-related Address Data
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), product information and CE marking if applicable
Hint
- Depending on the type of product, the following documents must be enclosed with the order:
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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))
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Medical devices: Label and package leaflet with CE mark
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Other pharmacy-typical products: Label and package leaflet
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- 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