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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

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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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”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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”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

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”Can pharmacies or pharmaceutical wholesalers order Ärztemuster? | No, Ärztemuster cannot be ordered by pharmacies or pharmaceutical wholesalers.“ more

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”Why do I have to notify both attributes 'Verifizierung im Pflichtbetrieb ab Hochladedatum' and 'Verifizierung im Pflichtbetrieb ab Verfalldatum' to IFA GmbH? | The attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab“ ... more