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”I will launch a medicinal product obliged to verification for the first time with a PZN. From what point in time can I upload serial numbers? | Generally, IFA GmbH transfers datas of PZN obliged to FMD at the time of their launch and first publication to ACS PharmaProtect“ ... more
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”Why is a change in the attributes Produktbezeichnung, Darreichungsform, Packungsgröße (Menge u. Einheit), Artikeltyp and Arzneimittel not permitted? | The desired change affects one of the so-called artikelidentifizierendes Merkmal (product identifying characteric):“ ... more
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”How is the allocation of the product-specific address data to the PZN conducted and how do I notify product-related address data for the first time? | The allocation of the product-specific address data to the PZN is usually conducted when ordering the first publication“ ... 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
HomeIFA for Data RecipientsData provisionEmail
”Delivery to an email inbox Provision You will receive an email with your individual Information Service The attachments contain your delivery files and the accompanying delivery information If the delivery exceeds a certain size we will pack it into a ZIP archive if“ ... more
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”What is a UDI-PI? Which elements need to be included? | Depending on the requirement for a medical device, the manufacturer determines the UDI-PI for his product and labels the packages accordingly. The UDI-PI can be the batch number, expiry date and, in certain cases,“ ... 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
HomeIFA for SuppliersNotification order documentsFirst publication of product data
First publication of product data
”Upon launch of the product on the German pharmaceutical market you notify a first publication of product data into the IFA Information Services Required order documents and further information by type of product Medicinal Product IFA Auftragstabelle B1 – First“ ... more
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”Do all physician samples have to bear a PZN from 09.02.2019? | Ärztemuster according to article 96 of the regulation 2001/83/EG must bear the security features according delegated act (EU) 2016/161 (article 2 and 41).A frequent question is how the samples need to be“ ... more
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”What purpose serve the attributes cmr-Gefahrstoff and UN-Nr. for data users? | These attributes are used by pharmaceutical wholesalers, pharmacies and doctors to i. a. handle the products legally conform and to use them correctly – in general but also unexpected“ ... more
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