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”Where on the pack does the Data Matrix Code have to be affixed? | Positioning is neither regulated in the FMD 2011/62/EU nor the Delegated Regulation (EU) 2016/161. The pharmaceutical entrepreneur determins the positioning due to the pack's layout and printing“ ... more

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”Where can I find further information on implementing the FMD in the IFA database? | Information on implementing the Falsified Medicines Directive 2011/62/EU (FMD) and its Delegated Regulation (EU) 2016/161 (dVO) in the IFA database can be found in Guidelines for Notifying“ ... 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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”What purpose does the 'PNR' in the IFA Information Services have? | PNR (Nummer des Pharmazeutischen Unternehmers - number of the pharmaceutical entrepreneur, assigned by BfArM) is used for internal purposes in relation to implementing the FMD. It is not issued as part of“ ... more

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”How do I have to code multi market packs meant for the German and Austrian market? | Because the Austrian PZN is linked via the database with the pack's product code, it is not included in the product code of multi market packs. If the product code a GTIN given by the“ ... 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

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”What considerations are necessary during a PZN transfer to another supplier? | A PZN transfer to another supplier will only be processed, if both an order from the new supplier and the previous supplier's consent to the PZN transfer have been received. Both, already“ ... more

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”What happens to packs not bearing the security features? | Packs of medicinal products obliged to verification not bearing the security features made dispensable before 09.02.2019 remain as such until the end of their expiration date. Packs of medicinal products obliged“ ... more

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”Are there any security features? | The pack's security features of medicinal products obliged to verification are:a) anti-tampering deviceb) unique identifier, consisting of four data elements in the Data Matrix Code.“ more

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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