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”What is UDI? | UDI (Unique Device Identification) is a system to uniquely identify medical devices worldwide according to Article 27 of the MDR (Regulation (EU) 2017/745 dated 05.04.2017). UDI is the broader term for a unique product identification consisting of the“ ... more

HomeIFA GmbHIFA current information

IFA current information

”15.05.2023 | Your IFA notifications - timely and efficient | "... recently we informed you in a German-speaking mailing about the new possibilities to comfortably view and edit your published product data via IFA portal. In the course of this innovation process, we would“ ... more

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”Is a specific format required for the expiry date? | Annex I, Chapter III No. 23.2. point i) MDR requires an unambiguous indication of the time limit for using the device safely. It includes at least the year and month, where this is relevant. In the code, the date format“ ... more

HomeIFA for SuppliersIFA information on PZN

IFA information on PZN

”Here you can find detailed information on the structure of the PZN and for encoding the PZN in code 39 Please note All IFA information are only available in German Pharmazentralnummer als Strichcode im Code 39 [DE]Information on creating PZN barcode in Code 39 and to“ ... more

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”Is a specific format required for the date of manufacture? | No, the manufacturer decides according to QM-specifications if he expresses the date of manufacture in days or months. In the code, the date format YYYYMMDD is provided.“ more

HomeIFA GmbHIFA current information

IFA current information

”14.03.2024 | Your IFA notifications for the ALBVVG data fields | "... as of 01.02.2024, the IFA database was expanded to include the requirements of the Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz (ALBVVG). The notification situation for“ ... more

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”What does notifying the attribute 'Verifizierung im Pflichtbetrieb ab Verfalldatum' mean – when and how do I notify it? | The attribute Verifizierung im Pflichtbetrieb ab Verfalldatum depicts the shelf life of the first batch obliged to verification. It is used to“ ... more

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”I'm a manufacturer of a product published in the IFA information services. Why can’t I change the data of my product without approval of the listed supplier? | Agreements between manufacturer and supplier can be very complex. It is impossible for the IFA GmbH to judge“ ... more

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”Why is a manufacturing / wholesale licence required? | A manufacturing authorization (Herstellungserlaubnis) according to § 13 of German Medicinal Products Act (Arzneimittelgesetz – AMG) is required by all entrepreneurs, that manufacture medicinal products“ ... more

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”What do the abbreviations mean in connection with the distribution channels? | The following abbreviations are used in the IFA documentation with the channels of distribution information: KVA / Krankenh.Apo. // VWeg KVA – distribution to hospital“ ... more