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”What should be considered when choosing the status discontinued? | A product is labelled as discontinued (AV), the item is removed from the market and will not be re-supplied. However, stock may be sold-off. These Products retain this distribution status until they are“ ... more

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”Of what does the unique identifier consist? | The unique identifier consists of: a) product numberb) individual serial numberc) batch numberd) expiry date It is used to check the medicinal product's authenticity and to identify individual packs. The data elements are“ ... more

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”How do I notify the attributes 'Verifizierung im Pflichtbetrieb ab Hochladedatum' and 'Verifizierung im Pflichtbetrieb ab Verfalldatum' for new publications after 15.02.2019? | First publications from 15.02.2019 have to if they: were released by the pharmcaceutical“ ... more

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”How do I notify the master data for German-Austrian multi market packs? | The pharmaceutical entrepreneur on the one hand notifies the determined product code with the Austrian PZN to the Austrian Apothekerverlag for data connection. On the other hand it notifies EMVO the“ ... more

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”I want so sell my product through pharmacies. Under which conditions can I receive a Pharmazentralnummer (PZN)? | Receiving PZN and their publication requires the signing of IFA's supplier contract outlining the buisiness relations.A PZN is issued while product data are“ ... more

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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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”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