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”What types of Bestandsware not obliged to verification are there in the transition period after 09.02.2019? | Bestandsware (released prior to 09.02.2019) may have three versions: Type 1: without security features, thus no anti-temper device and no distinctive“ ... more

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”Why do I need to send Zulassungsunterlagen (MA documents) with every first publication of a medicinal product? | Generally, only authorised (zugelassen or registriert) medicinal products may be marketed. Since the MA documents constitute proof of legitimate authorization“ ... 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

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Deletion of product data

”If a product is no longer distributed you can request the deletion of the product from the IFA database and thus from the information systems Deleted PZNs cannot be published again Deletion of medicinal products First the medicinal product must set Außer“ ... more

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”Why is raw data supplied and not software? | As a neutral and central service provider for standardised and quality-assured information in the health sector, IFA GmbH is committed to harmonising data and provides raw data. These offer data recipients the possibility to“ ... more

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”May I choose between PPN and NTIN as product code for coding? | Yes, you may choose between PPN and NTIN. The pharmaceutical entrepreneur chooses which product code to use for coding. Both follow the same ISO- standards and contain the embedded PZN. The difference is on“ ... more

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”Which products are obliged to verification and are there any exceptions? | Obliged to verification are all prescription-only medicinal products for human use that are not mentioned as an exception in the White List (i. a. some homoepathics). Furthermore, OTC medicinal“ ... more

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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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”May packs not bearing security features still be dispensed after 09.02.2019? | Yes, if it is actual Bestandsware released to the market prior to the 09.02.2019. For the systems to identify these packs as Bestandsware, the pharmaceutical entrepreneur must notify the“ ... more

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”How to notify the overruling of a manufacturer's discount in a reimbursement amount agreement? | You can notify this by entering the applicable value in the datafield Ablösung Abschlag § 130a SGB V – Overruled discount Section 130a SGB V. The notification“ ... more