Search

HomeFAQ

FAQ

”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

HomeFAQ

FAQ

”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

HomeFAQ

FAQ

”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

HomeFAQ

FAQ

”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

HomeFAQ

FAQ

”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

HomeDownloads

Downloads

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

HomeFAQ

FAQ

”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

HomeFAQ

FAQ

”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

HomeFAQ

FAQ

”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