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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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”Unique Device Identifier (UDI) | PPN-Code Specification for Retail Packaging (2,1 MB) more

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”What considerations are necessary during a supplier change? | A supplier change will only be processed if there is an order from the new supplier and the approval of the old supplier are handed into the IFA. Both, already published as well as pre-allocated PZN´s can“ ... more

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”Since when is the Data Matrix Code mandatory? | According to the delegated act (EU) 2016/161, the deadline 09.02.2019 is mandatory for all medicinal products obliged to verification.“ more

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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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”Can a pack bear more than one Data Matrix Code? If so, how do I recognise the relevante code? | Yes, a pack may bear more than one Data Matrix Code. The relevant Data Matrix Code to the pharmacy system is marked with the emblem PPN. Scanning other codes will be recognised“ ... more

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”Does the Data Matrix Code have to bear the emblem PPN (or NTIN)? | Yes, the PPN (or NTIN) emblem must be affixed next to the Data Matrix Code in clear print. If the pack bears different codes, using the PPN indicates the relevant code for verification. Exceptions from“ ... 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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”IFA Coding System | Pharmazentralnummer als Strichcode im Code 39 [DE] (238 KB) more

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”May I omit the PZN in Code 39 on the outer pack upon changing to the Data Matrix Code? | Pharmaceutical entrepreneurs are obliged to affix PZN in clear print and Code 39 or as Data Matrix Code (DMC) on the outer pack according to the amended frame agreement § 131 SGB“ ... more