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”What is the difference between a GTIN and an NTIN? | The NTIN is a specific type of GTIN where existing national numbers, such as for example the PZN, are encoded in a way to make it internationally unique. The difference lies in generating the GTIN. With the NTIN the“ ... more
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”Under what circumstances is an article no longer subject to verification? | If a product is no longer subject to prescription, the verification obligation is usually also not required. The manufacturer is obliged to recall the product with the affected safety features and“ ... more
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”I do not understand the charged manufacturer discounts. Which law regulates manufacturer discounts? | The manufacturer discounts are regulated in § 130a SGB V for medicinal products billed to the GKV, and in § 1 AMRabattG for medicinal products billed to the PKV“ ... more
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”Which documents and attributes do I have to submit for the first publication of physician samples into IFA’s Database? | In general, notifying physician samples is not treated differently to medicinal products of the type standard. The following documents have to be“ ... more
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”From what point in time do I need a UDI-DI for my medical device? | With the date of the MDR's application on 26.05.2021, a UDI-DI must be assigned to each medical device. For in vitro diagnostic medical devices, this goes from the application of the IVDR (delegated act“ ... more
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”What is a UDI-PI? Which elements need to be included? | Depending on the requirement for a medical device, the manufacturer determines the UDI-PI for his product and labels the packages accordingly. The UDI-PI can be the batch number, expiry date and, in certain cases,“ ... more
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”I am a manufacturer of medical devices that will be sold through pharmacies and chemists. What do I have to do if chemists and supermarkets possibly cannot scan the DMC? | Currently, these products usually bear an EAN code. The PZN is usually in clear print and“ ... more
HomeIFA for SuppliersNotification order documentsChange and deletion of product data
Change and deletion of product data
”You can use the following notification order documents to order product changes and deletions to product and address data that has been published already Change and addition of product data IFA portal orRequest a current EAD file or IFA Auftragstabelle C –“ ... more
HomeIFA Coding SystemEncoding of PZN in Code 39
Encoding of PZN in Code 39
”The Pharmazentralnummer PZN is the German tag according to § 300 SGB V which has to be affixed by the pharmaceutical entrepreneurs onto the outer pack of medicinal products in accordance with § 131 SGB V This can be done via Code 39 and the PZN in clear print“ ... more
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”What is to be considered when coding UDI? | The UDI-DI (PPN) and the manufacturer's determined UDI-PI have to be included in compliance with IFA's Coding System in the Data Matrix Code. Any other data elements may be, but are not obliged to be, included in the Data Matrix“ ... more