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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
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”How do I define the UDI-PI? | In accordance with the requirements regarding certain medical devices the manufacturer defines the characteristic(s) suitable for product traceability.“ more
HomeIFA for SuppliersNotification order documents
Notification order documents
”You may submit your notification orders to IFA GmbH using excel order files XLSX format Please fill in a complete order and send it by email to ifa@ifaffm de Further information on how and when notifying an order as well as explanations to each order type and“ ... more
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”I have reported my medical device in the IFA database. Do I also have to register it in EUDAMED? | Yes, because your product data will not be forwarded to EUDAMED by IFA GmbH.“ more
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”Where can I find information on the anti-tampering device? | The anti-tampering decive, preventing interferance with the product, makes the first opening of the pack evident. Further information on the different options can be found on the website of the Deutsches“ ... more
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”What does notifying the attribute 'Verifizierung im Pflichtbetrieb ab Hochladedatum' mean – when and how do I notify it? | With the attribute Verifizierung im Pflichtbetrieb ab Hochladedatum the pharmaceutical entrepreneur determins the medicinal product's obligation to“ ... more
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”What data elements may / must the data matrix code include for OTCs? | For packs not obliged to the falsified medicines directive (FMD), the Data Matrix Code may be used optionally according to the coding regulations. The DMC has to contain at least the product code in“ ... more