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”What is a UDI-DI? | The UDI-DI (UDI Device Identifier) is a unique product identifier, which is assigned to the product itself or its packaging. For the use of the IFA Coding System, the PPN is used as the UDI-DI. The PPN represents the PZN in an internationally“ ... more

HomeIFA for SuppliersNotification order documentsFirst publication of product data

First publication of product data

”Upon launch of the product on the German pharmaceutical market you notify a first publication of product data into the IFA Information Services Required order documents and further information by type of product Medicinal Product IFA Auftragstabelle B1 – First“ ... more

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”What purpose do the verification attributes have in the IFA database? | The two attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum in the IFA database help to determine medicinal products obliged to verification“ ... more

HomeIFA for Data RecipientsData provisionProvision dates

Provision dates

”Calendar for delivery or retrieval of the IFA Information Services In accordance with the updating of the IFA database on the 1st and 15th of each month the IFA information services are provided 5 working days before the effective date update or publication date “ ... more

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”How is the allocation of the product-specific address data to the PZN conducted and how do I notify product-related address data for the first time? | The allocation of the product-specific address data to the PZN is usually conducted when ordering the first publication“ ... more

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”Are there special requirements for me when I use my PPNs as UDI-DIs? | No, because IFA guidelines already concur with the MDR. Please note that Appendix VI of the MDR calls for special issuing rules for UDI-DIs.“ more

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”What is EUDAMED? | The EU Commission shall set up a central database (EUDAMED) for medical devices according to Article 28 MDR.“ more

HomeIFA for SuppliersNotification order documentsFirst publication and change in address data

First publication and change in address data

”Detailed information can be found in the new customer section on our website New Customers For changing a company’s name we need the Supplier Address Data Excel Order File D and a current copy of the trade registry excerpt of the company IFA Auftragstabelle D“ ... more

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”I will launch a medicinal product obliged to verification for the first time with a PZN. From what point in time can I upload serial numbers? | Generally, IFA GmbH transfers datas of PZN obliged to FMD at the time of their launch and first publication to ACS PharmaProtect“ ... more

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”Do I have to affix the serial number in clear print onto the pack? | Yes, the Delegated Regulation (EU) 2016/161 requires the serial number in clear print. An exception can be made for small packs (sum of two smallest sides < 10 cm).“ more