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 (SmPC) and Marketing Authorisation (MA) – AMIce extract preferred
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.
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