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”Why do I have to include product information for first publication and for changes to certain legal information? | The product information is used i. a. to:The specifications in the software of for example pharmacies or pharmaceutical wholesalers shall match as closely as“ ... more
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Legal notice
”Informationsstelle für Arzneispezialitäten – IFA GmbH Hamburger Allee 26 – 2860486 Frankfurt am MainPhone: +49 69 979919-0Email: ifa@ifaffm.deInternet: https://www.ifaffm.de/enGeschäftsführer: André MaskeVorsitzender des“ ... more
HomeIFA for Data RecipientsData provisionEmail
”Delivery to an email inbox Provision You will receive an email with your individual Information Service The attachments contain your delivery files and the accompanying delivery information If the delivery exceeds a certain size we will pack it into a ZIP archive if“ ... 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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”Do physician sample packs have to bear a PZN in clear print or in a code (DMC or Code 39)? | Affixing a PZN in clear print or Code 39 to medicinal products dispensed as physician samples (product type Ärztemuster gemäß AMG in the IFA database) is legally“ ... more
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”Do all physician samples have to bear a PZN from 09.02.2019? | Ärztemuster according to article 96 of the regulation 2001/83/EG must bear the security features according delegated act (EU) 2016/161 (article 2 and 41).A frequent question is how the samples need to be“ ... more
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”What is a Generikaabschlag? | A Generikaabschlag (generics discount) is the manufacturer's discount according to § 130a paragraph 3b SGB V. Further information can be found in the Leitfaden Herstellerabschläge (Rahmenverträge zur Arzneimittelversorgung >“ ... more
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”What purpose serve the attributes cmr-Gefahrstoff and UN-Nr. for data users? | These attributes are used by pharmaceutical wholesalers, pharmacies and doctors to i. a. handle the products legally conform and to use them correctly – in general but also unexpected“ ... more
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”What happens if I do not notify the attributes for my medicinal products obliged to verification 'Verifizierung im Pflichtbetrieb ab Hochlade- / Verfalldatum'? | If the supplier fails to notify the attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and“ ... more
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”What clear print requirements are there for German-Austrian multi market packs? | As for single market packs, the four elements of the unique identifier (UI) must be affixed in clear print adding the nationally predefined label. Please pay attention to the requirments of“ ... more
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