Source: https://www.ifaffm.de/en/glossary.html
Timestamp: 2020-02-19 21:55:28
Document Index: 484528576

Matched Legal Cases: ['§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 130', '§ 47', '§ 78', '§ 129', '§78', '§ 78', '§ 78', '§ 130', '§ 130', '§ 130', '§ 130', '§ 2', '§ 52', '§ 52', '§ 51', '§ 51', '§ 51', '§ 130', '§ 1', '§ 24', '§ 130', '§ 1', '§ 3', '§ 2', '§ 9', '§ 6', '§ 31', '§ 78', '§ 78', '§ 78', '§ 3', 'Art. 2', '§ 4', '§ 24', '§ 130', '§ 130', '§ 52', '§ 4', '§ 2', '§ 13', '§ 130', '§ 130', '§ 130', '§ 3', '§ 3', '§ 3', '§ 3', '§ 3', '§ 31', '§ 31', '§ 3', '§ 5', '§ 24', '§ 9', '§ 130', '§ 47', '§ 47', '§ 130', '§ 31', '§ 10', 'Art. 1', '§ 4', '§ 4', '§ 130', '§ 3', '§ 3']

Detailed information on IFA attributes can be found in the guidelines Richtlinien zur Meldung von Artikel- und Adressdaten.
You can find all IFA guidelines here. Please note that all information in the guidelines is given in German only.
The ABDA – Federal Union of German Associations of Pharmacists is the umbrella organisation of pharmacists in Germany. Its aim is combining and bringing forward the common interests of this healthcare profession.
ABDATA Pharma-Daten-Service, a business branch of Avoxa – Mediengruppe Deutscher Apotheker GmbH develops and produces medicinal product data for different areas of the health care industry.
Ablösung des Abschlags gemäß § 130a Abs. 1 SGB V
These IFA attributes are used to notify the overrule of deduction in accordance with § 130a Abs. 1 SGB V following an agreement according to § 130b Abs. 1 Satz 4 SGB V corresponding § 130a Abs. 8 SGB V resp. according to § 130a Abs. 1a SGB V following an agreement according to § 130b Abs. 1 Satz 4 SGB V corresponding § 130a Abs. 8 SGB V.
Abschlagsbefreiung | Exemption of Deduction
This IFA attribute is used to notify the level of exemption according to § 130a Abs. 4 SGB V of the medicinal product, provided it is claimed.
§ 130a Abs. 4 SGB V von den Abschlägen gemäß § 130a Abs. 3a SGB V:
This IFA attribute is used to notify the level of exemption according to § 130a Abs. 3a SGB V of the medicinal product, provided it is claimed.
§ 130a Abs. 9 SGB V von den Abschlägen gemäß § 130a Abs. 1 bzw. 1a SGB V:
This IFA attribute is used to notify the level of exemption according to § 130a Abs. 1 bzw. 1a SGB V of the medicinal product, provided it is claimed.
§ 130a Abs. 9 SGB V von den Abschlägen gemäß § 130a Abs. 3a SGB V:
ACS PharmaProtect GmbH has been made system operator by securPharm e. V. in the context of implementing the FMD. It is responsible for the contractual and technical connection of pharmaceutical entrepreneurs concerned in the German pharmaceutcial market (ACS-PU-System).
AEP PPU | Pharmacy Purchase Price PPU
The IFA attribute Apothekeneinkaufspreis des pharmazeutischen Unternehmers – AEP PPU is used to display the pharmacy purchase price of the pharmaceutical entrepreneur for medicinal products with reimbursement in accordance with § 130b SGB V.
For these medicinal products, the AEP PPU may vary from the AEP. It is calculated from its PPU in accordance with AMPreisV and does not contain VAT.
AEP | Pharmacy Purchase Price
The IFA attribute Apotehekneinkaufpreis – AEP is used to display the pharmacy purchase price. It does not include VAT.
Aerztemuster gemäß AMG | Physician Sample acc. to AMG
IFA's product type Ärztemuster gemäß AMG is used to notify a medicinal product that is dispensed as physician sample according to AMG. This product type can be used exclusively for medicinal products that are dispensed according to § 47 paragraph 3 and 4 AMG as physician samples.
Betäubungsmittel (Verordnung auf BtM-Rezept) and medicinal products with the active agents Lenalidomid, Pomalidomid and Thalidomid (Verordnung auf T-Rezept) are exempt.
Aktualisierungsfrequenz | Update Frequency
The IFA attribute Aktualisierungsfrequenz is the update frequency of IFA information services passed on to IFA data recipients per year.
AMG | Medicinal Products Act
The purpose of the German Arzneimittelgesetz – AMG is to ensure safety in the marketing of medicinal products, in particular for quality, effectiveness and harmlessness, in the interests of the proper supply to humans and animals.
AMK – Arzneimittelkommission der Deutschen Apotheker
Arzneimittelkommission der Deutschen Apotheker – AMK is an institution of ABDA. It gathers phamrmacists' suspicious transactions regarding medicinal products' quality and adverse drug reaction.
AMPreisV | Pharmaceutical Price Ordinance
The German Arzneimittelpreisverordnung – AMPreisV determins prices and price ranges in the trade of prescription-only medcinal products and veterinary medicinal products in Germany.
The IFA attribute AMPreisV AMG is used to display prices according to § 78 AMG for prescription-only medcinal products.
The IFA attribute AMPreisV SGB V is used to display prices according to § 129 Abs. 5a SGB V – respective AMPreisV effective 31.12.2003 – for pharmacy-only, not rescription-only, medcinal products.
Anbieter | Supplier
A supplier within the meaning of IFA GmbH is a company that markets pharmacy typical products in Germany. The supplier can be manufacturer, distributor, co-promoter, local representative, importer or designated wholesaler.
ANSG | Guarantee of Emergency Pharmacy Service Act
The Apothekennotdienstsicherstellungsgesetz – ANSG is an act to fund pharmacies to be open during night-time.
Anthroposophikum | Anthroposophic Medicine
The IFA attribute Anthroposophikum is used to notify registered or authorised medicinal products manufactured according to approved anthroposophic production techniques.
ApBetrO | Pharmacy Practice Ordinance
Apothekenbetriebsordnung – ApBetrO regulates a secure and good supply of medicinal products via pharmacies. This includes manufacturing, testing and storage of medicinal products but also its dispense, consulting and informing patients.
Apotheken, öffentliche | Pharmacies
This IFA distribution channel is used to notify products that are sold through pharmacies.
apothekenpflichtig | Pharmacy-only
This IFA attribute apothekenpflichtig is used to notify medicinal products or medical devices respectively that are pharmacy-only.
APU | Wholesale Price
The IFA attribute Abgabepreis des pharmazeutischen Unternehmers – APU is used to display the wholesale price. For other pharmacy typical products, the APU is the selling price of the supplier. It does not include VAT.
APU §78 3a S.1 AMG
This IFA attribute APU § 78 Abs. 3a Satz 1 AMG is used to display the wholesale price of the supplier according to § 78 Abs. 3a Satz 1 AMG of medicinal products with reimbursement.
This price matches the level of reimbursement according to § 130b SGB V of medicinal products and does not include VAT.
Artikel-Nr. – (Kunden-) | Product Number
The IFA attribute Artikel-Nr. is used to display a product number assigned to the product by the supplier.
Artikelidentifizierende Merkmale | Product Identify. Character.
A PZN's product identifying characteristics are Produktbezeichnung | shortened product name, Packungsgröße (Menge und Einheit) | packages size, Darreichungsform | pharmaceutical form, attribute Arzneimittel and Artikeltyp | product type. These attributes uniquely identify a product of a sepcific supplier.
Artikeltyp | Product Type
The IFA attribute Artikeltyp is used to differentiate between products with the same product identifying features:
- Standard | standard
- Klinikpackung | clinic pack
- Klinikbaustein | clinic pack component
- Pandemieartikel | pandemic product
- Schüttware | bulk product
- Ärztemuster gemäß AMG | physician sample according to AMG
Arzneimittel mit Erstattungsbetrag § 130b SGB V
The IFA attribute Arzneimittel mit Erstattungsbetrag § 130b SGB V is used to notify medicinal products with a reimbursement (§ 130b SGB V).
Arzneimittel | Medicinal Product
The IFA attribute Arzneimittel is used to notify medicinal products (Fertigarzneimittel) according to § 2 Abs. 1, Abs. 2 Nr. 1 AMG.
Ausgabe d. Zuteilung | Data transfer of pre-allocations (to ACS)
Asking IFA GmbH to transfer data of your pre-allocated PZNs of medicinal products obliged to the FMD to ACS prior to their planned launch into the market and the PZNs’ publication into IFA’s information services increases the time frame for the initial upload of serial numbers into the EU hub or to ACS PharmaProtect GmbH.
Ausnahme nach § 52b Abs. 2 S. 3 AMG
The IFA attribute Ausnahme nach § 52b Abs. 2 Satz 3 AMG – no dispense to pharmaceutical wholesalers – is used to notify medicinal products, that are exempt from the obligatory dispense to pharmaceutical wholesalers.
Ausnahmereg. § 51 AMG
The IFA attribute Ausnahmereg. § 51 AMG – exemption from dispense in travel trade – is used to notify not pharmacy-only medicinal products that are exempt from the prohibition according to § 51 AMG.
AV – außer Vertrieb | Discontinued
The IFA distributive state außer Vertrieb – AV is used to notify products that are marked permanently as discontinued by the supplier. These products will no longer be marketed, remaining quantities in the market may still be sold.
PZN/products marked as AV must not be reactivated.
AVP PPU | Pharmacy Retail Price PPU
The IFA attribute Apothekenverkaufspreis des pharmazeutischen Unternehmers – AVP PPU is used to display the pharmacy retail price of the pharmaceutical entrepreneur for medicinal products with reimbursement in accordance with § 130b SGB V.
For these medicinal products, the AVP PPU may vary from the AVP. It is calculated from its PPU in accordance with AMPreisV and contains VAT.
AVP | Pharmacy Retail Price
The IFA attribute Apothekenverkaufspreis – AVP is used to display the pharmacy retail price. It includes the VAT.
BAH – Bundesverband der Arzneimittel-Hersteller e. V.
BAH, with its over 420 members, is the leading trade organisation for the pharmaceutical industry in Germany. Due to the high level of professional competence and expert knowledge, BAH is a close contact partner for politicians, authorities and health institutions
BattG | Comp. Notification acc. to Batteries Act
The German BattG – batteries act aims to reduce the environmental impairments and regulates the distribution, return and disposal of batteries and accumulators. All batteries are affected; never mind their shape, size, mass, composition or usage and for those used in other products (§ 1 Abs. 1 BattG).
BattG/UBA | Comp. Notific. acc. to Batteries Act
The IFA attribute BattG/UBA is used to notify products that are subject to the compulsory notification according to BattG and thus notified to Umweltbundesamt – UBA.
bezugnehmende Zulassung als Generikum
The IFA attribute bezugnehmende Zulassung als Generikum is used to notify generic medicinal products according to § 24b Abs. 2 AMG.
BfArM | Federal Institute for Drugs and Medical Devices
BfArM is the federal institute within the ministry of health dealing with marketing authorisations and registrations of medicinal products.
Among other tasks, BfArM deals with pharmacovigilance, centralised risks gathering of medical devices, monitoring the legal marketing of BtM and advising the government.
BfArM-Eingangs-Nr. | BfArM Submission Number
The IFA attribute BfArM-Eingangs-Nr. is used to display the submission number issued by BfArM during the marketing authorisation process of a medicinal product.
Biologisches Arzneimittel | Biological Medicinal Products
The IFA attribute biologisches Arzneimittel is used to notify biological medicinal products within the meaning of the Leitfadens zur Definition des Generikaabschlages.
This notification is necessary to determine the compulsory deduction according to § 130a Abs. 3b SGB V, the so-called Generikaabschlag.
Biotechnol. hergestelltes Arzneimittel | Biotechnological Med.P.
The IFA attribute biotechnologisch hergestelltes Arzneimittel is used to notify medicinal products that are manufactured with one of the following procedures:
- Technology of recombined DNS;
- controlled expression to procaryotes and eukaryotes including transformed mammal cells, of genes that encode for biologically active proteins;
- procedure on the basis of hybridoma technology and Verfahren auf der Basis von Hybridomen und monoclonal antibodies.
Biozid | Biocidal Product
Tha IFA attribute Biozid is used to notify registered biocidal products.
Biocidal products are used for pest control or disinfection – thus products that are not applied to alive crop.
BOPST | Federal Opium Agency
The Bundesopiumstelle – BOPST is one of 13 departments at the BfArM (Federal Institute for Drugs and Medical Devices). It governs the marketing of narcotics on the basis of BtMG.
BOPST-Nr. | BOPST Number
This IFA attribute is used to display the BOPST-Nr. of narcotics. The number has 8-digits and is issued by the BOPST.
BPI is the German stakeholder for companies in the pharmaceutical industry.
BtM | Narcotic Drug
The IFA attribute Betäubungsmittel – BtM is used to notify narcotic drugs according to § 1 BtMG or ausgenommenen Zubereitungen according to § 3 in connection with § 2 BtMG.
BtMG | Narcotic Drugs Act
The German narcotic drugs act – BtMG regulates handling and external trade with BtM.
CE-Kennzeichnung | CE Marking
The IFA attribute CE-Kennzeichnung is used to notify that the product bears a CE marking in accordance with § 9 MPG. According to § 6 MPG, medical devices must bear a CE marking to be marketed.
cmr-Gefahrstoff | cmr Substance
The IFA attribute cmr-Gefahrstoff is used to notify products (including medicinal products) that contain one or more ingredients (including active agents) that are on their own or in combination cancerogenic, mutagenic or reprotoxic according to GefStoffV.
Darreichungsform | Pharmaceutical Form
The IFA attribute Darreichungsform is used to display the pharmaceutical form (technologisch-pharmazeutische Zubereitung) in which medicinal products or drug-similar products are dispensed such as pill. Medicinal product's pharmaceutical form is stated in section 3 of the SPC Fachinformation.
The pharmaceutical form of other pharmacy-typical products should match the one mentioned in the product information.
Datenbezieher | Data Recipients
Datenbezieher within the meaning of IFA GmbH are companies (i. e. pharmaceutical wholasalers, software providers) that receive and handle IFA Informations Services.
Datennutzer | Data Users
Datennutzer within the meaning of IFA GmbH are people, institutions and companies that analyse but not pass on IFA Information Services (i. e. pharmaceutical wholesalers, pharmacies, physicians).
Diätetikum | Dietary Supplement
The IFA attribute Diätetikum is used to notify dietary supplements either in accordance with § 31 Abs. 5 SGB V or other dietary supplements.
DiätV | Dietary Supplement Regulation
Dietary foods within the meaning of DiätV are food products for special medical purposes (bilanzierte Diäten).
Diff. PPU-APU § 78 Abs. 3a Satz 1 AMG
The IFA attribute Diff. PPU-APU § 78 Abs. 3a Satz 1 AMG additionally displays the difference between PPU and Abgabepreis gemäß § 78 AMG for medicinal products if both are notified.
Droge/Chemikalie | Drugs/Chemicals
The IFA attribute Droge/Chemikalie is used to notify substances within the meaning of § 3 AMG that are generally used to manufacture medicinal products.
EAD | Electronic Data Processing Order
EAD files are used to notify product data changes such as price changes or discontinuing a product (AV – außer Vertrieb) fast and easily. You may order different EAD files from our website Request the current EAD or Product Range File.
Information in German on working with EAD files can be found in our guidelines Richtlinien zur Meldung von Artikel- und Adressdaten.
The European Article Number is the former name of the Global Trade Item Number (GTIN). It provides an internationally unique product identification for commercial articles.
EG-Kosmetik-Verordnung | Cosmetics
The IFA attribute EG-Kosmetik-Verordnung is used to notify cosmetics that are subject to the EG-Kosmetikverordnung.
EG-Cosmetics-Regulation contains guidelines to protect human health referring i. a. to mark cosmetics, transportation and storage.
Eichung/Laufzeit der Eichung | Calibration
The IFA attribute Eichung is used to notify products that are subject to mandatory calibration. Laufzeit der Eichung is used to display the month until the product needs to be calibrated again.
Einzelhandel, sonstiger | Sales Information
The IFA attribute sonstiger Einzelhandel is used to notify that the product is sold through other retail trade such as Drogerien, Reformhäuser, Sanitätshäuser etc.
ElektroG | Electronics Act
ElektroG regulates the placing on the market, return and environmentally friendly disposal of electric appliances and electronics.
ElektroG/ear | Comp. Registration stiftung ear
The IFA attribute ElektroG/ear is used to notify products whose manufacturer is subject to compulsory registration with stiftung ear according to ElektroG.
ElektroStoffV | Regulation of Electric Devices
The IFA attribute ElektroStoffV is used to notify electronics and electric appliances according to ElektroStoffV. These products call for special marking and validation of the marking by the supplier.
ElektroStoffV describes which toxic substances to what concentration may be containted in electronics.
EMA is an EU agency that evaluates applications of medicinal products' marketing authorisations – so-called Zentrale Zulassungen – and working to achieve pharmacovigilance.
emvo – European Medicines Verification Organization
emvo's task within the scope of implementing the FMD is coordinating the verification on a European level. It hosts the European hub organising verification queries from European countries.
Erfassungsintervall | Acquisition Period
The Erfassungsintervall is the period in which data of publications or product changes are processed for one IFA information service.
EU-Bio-Siegel | EU-Organics-Seal
The IFA attribute EU-Bio-Siegel is used to notify products that are subject to the EG-Öko-Basisverordnung and thus bear an EU organics-seal.
Explosivgrundstoff | Explosives Precursors
The IFA attribute Explosivgrundstoff is used to notify products that are substances in accordance with the regulation's appendix to Art. 2 (EU) Nr. 98/2013.
Fertigarzneimittel | Finished Medicinal Product
According to § 4 (1) of the AMG, finished medicinal products are medicinal products which are produced in advance and are marketed in packs suitable for users or other medicinal products for users of which are manufactured in an industrial or, with the exception of pharmacies, commercial way. Finished medicinal products are not intermediates, which are intended for further processing by a manufacturer.
Feuchteempfindlichkeit | Moisture Sensitive
The IFA attribute Feuchteempfindlichkeit is used to notify products that need special storage due to their moisture sensitivity.
FMD – Falsified Medicines Directive 2011/62/EU
The EU predetermined measures to protect patients against falsified medicinal products in the legal supply chain.
Legal basis are FMD 2011/62/EU (Falsified Medicines Directive) and the delegated regulation (EU) 2016/161.
Since 09.02.2019, pharmaceutical entrepreneurs may market medicinal products obliged to verification only once they bear the two mandatory security features. Further information on implementing the FMD can be found here or in IFA GmbH's FAQ section.
GefStoffV | Ordinance on Hazardous Substances
The ordinance GefStoffV is in place to protect humans and the environment against hazardous substances.
It is also directed at marketing of hazardous substances and activities that may harm peoples' health or security by being exposed to substances, mixtures or products.
Generika | Generics
Generics are original medicinal products of the same type, active agent and pharmaceutical form but no longer subject to patent protection (cf. § 24b AMG).
Generikaabschlag | Generic Discount
A Generikaabschlag according to § 130a Abs. 3b SGB V is a manufacturer discount which legal warranty is regulated in § 130a SGB V.
The IFA attribute Gewicht is used to display the product's gross weight meaning the actual contents including its packing in gramme (rounded up to whole number).
Großhandelserlaubnis | Wholesaler Authorisation
All suppliers marketing medicinal products professionally must hold a Großhandelserlaubnis according to § 52a AMG. Marketing is trading, acquiring, storage and dispense or export of medicinal products according to § 4 Abs. 22 AMG.
GTIN | Global Trade Item Number
The IFA attribute GTIN – formerly EAN – is used for products that may be sold outside of pharmacies to display the code for the product. This 14-digit code is used globally to identify a product of a specific colour, size, etc.
Manufacturer of Nahrungsergänzungsmittel (food supplements) in the sense of IFA’s Guidelines are companies that manufacture food supplements and are responsible for the safety of these products. The manufacturer does not necessarily have to be the supplier of the PZN.
Herstellungserlaubnis | Manufacturing Authorisation
All pharmaceutical entrepreneurs manufacturing medicinal products in accordance with § 2 AMG must bear a Herstellungserlaubnis according to § 13 AMG. Manufacturing includes production, preparation and approval of medicinal products.
Hilfsmittel zum Verbrauch | Devices for Consumption
The IFA attribute HiMi z. Verb. is used to notify products that are Hilfsmittel zum Verbrauch according to SGB V. In contrast to Hilfsmitteln according to SGB V without further specification, Hilfsmittel zum Verbrauch are for onetime use only. This attribute is important for additional payments and thus affects patients directly. Further information on this topic can be found here.
Homöopathikum | Homeopathics
The IFA attribute Homöopathikum is used to notify registered or authorised medicinal products that are manufacturered according to approved homeopathic preparation methods.
IFA-Datenbank | IFA Database
The IFA database contains legal and logistic product data of medicinal products and other pharmacy typical products notified by the supplier.
These product data provide the requirements for the participants within the healthcare sector such as physicians, pharmacies, pharmaceutical wholesalers and health insurances to properly fulfil their tasks in the market in accordance to legal prerequisites.
IFA-Informationsdienst | IFA Information Service
IFA information service contains new and changed product data of the IFA database as raw data. They are provided to the data recipients usually 10 respectively 5 working days prior to the publication date.
Impfstoffabschlag – § 130a Abs. 2 SGB V
Impfstoffabschlag nach § 130a Abs. 2 SGB V (vaccine deduction) is one of the Herstellerabschläge, which legal guarantee is regulated in § 130a SGB V.
Import-AM – importiertes Arzneimittel lt. SGB V
The IFA attribute Import-AM is used to notify re- or parallel imported medicinal products with special regulations according to SBG V.
In-Vitro-Diagnostika-Klasse | IVD Class
The IFA attribute In-vitro-Diagnostika-Klasse is used to notify the classification of medical devices in accordance with § 3 MPG taking into account the Zweckbestimmung and connected risks. Classification is done in accordance with regulation (EU) 2017/746 in classes A, B, C or D.
IV – in Vertrieb | Active
Products with the distributive state im Vertrieb – IV are actively available in the pharmaceutical market and marketed by the supplier.
KHAEP | Hospital Pharmacy Purchase Price
The IFA attribute Krankenhausapothekeneinkaufspreis – KHAEP is used to display the hospital pharmacy purchase price. It does not include VAT.
Klinikbaustein | Product Type
The IFA product type Klinikbaustein is used to notify clinic components, the smallest unit of a clinic pack.
Klinikpackung | Product Type
The IFA product type Klinikpackung is used to notify clinic packs which are dispensed to hospitals exclusively.
The IFA attribute Kombinationspackung is used to notify combination packs of medicinal products consisting of more than one finished medicinal product.
Kontrazeptivum mit allein. Indik. | Contraceptive
The IFA attribute Kontrazeptivum is used to notify contraceptive medicinal products or medical devices used for borth control.
Kühlkette | Cold Chain
The IFA attribute Kühlkette is used to notify products very susceptible to temperature. These products must be kept in an uninterrupted cold chain during storage and transport.
KVA | Sales Information
The IFA attribute Krankenhausapotheken – KVA is used to notify that the product is sold through hospital pharmacies.
Lageemfindlichkeit | Position Sensitivity
The IFA attribute Lageempfindlichkeit is used to notify products that must be stored either upright or horizontal due to their position sensitivity.
Lagertemperatur min/max | Storage Temperature
The IFA attributes Lagerungstemperatur minimal and Lagerungstemperatur maximal are used to display minimal and maximal storage temperatures in degree Celsius meant for products with specific storage instructions.
Länge, Höhe, Breite | Length, Height, Width
These IFA attributes Länge, Höhe, Breite are used to display the product's package size in millimetre – including the outer pack.
Lebensmittel | Food Stuff
The IFA attribute Lebensmittel is used to notify Nahrungsergänzungsmittel, Diätetika or other food stuff marketed in accordance with LFGB.
LFGB | Food Stuff Act
German Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetz – LFGB act regulates consumer protection and food safety for both humans and animals.
Lichtempfindlichkeit | Light Sensitivity
The IFA attribute Lichtempfindlichkeit is used to notify products that must be stored specifically due to their sensitivity when exposed to sunlight or light.
Lifestyle Arzneimittel | Lifestyle Medicinal Products
The IFA attribute Lifestyle-AM is used to notify lifestyle medicinal products according to SGB V. Lifestyle mit Ausnahmeregelung might be reimbursed whereas Lifestyle ohne Ausnahmeregelung will not be reimbursed by the GKV.
LÖ – Löschung | Normal Product Deletion
The IFA distribution state Löschung – LÖ is used to notify products that were deleted from IFA Information Services by the supplier. The deletion will mark the product and its data as deleted or will delete it from all databases for IFA Data Recipients to identify.
Medizinprodukt gemäß § 3 MPG | Medical Device § 3 MPG
The IFA attribute Medizinprodukt gemäß § 3 MPG is used to notify medical devices in accordance with § 3 MPG.
Medizinprodukt gemäß § 31 Abs. 1 Satz 2 SGB V
The IFA attribute Medizinprodukt gemäß § 31 Abs. 1 Satz 2 SGB V is used to notify medical devices that are arzneimittelähnlich/stofflich according to SGB V.
Medizinprodukte-Klasse | Medical Devices Class
The IFA attribute Medizinprodukte-Klasse is used to notify medical device's classification according to § 3 MPG taking into account the Zweckbestimmung and connected risks. Classification is done in accordance with regulation (EU) 2017/745 in classes I, IIa, IIb and III.
Melderegister-Nr. UBA | Registration Number with UBA
The IFA attribute Melderegister-Nr. UBA is used to display the products registration number with UBA according to BattG. This 8-digit number indicates that the product has been lawfully notified with UBA.
Meldeschlusstermin | Notification Deadline
Processing a notification order for a desired publication date is subject to a complete order being submitted to IFA GmbH by the relevant notification deadline. The IFA Publication Calendar states all publication dates along with their notification dedalines.
Mindestbestellmenge | Minimum Order Quantity
The IFA attribute Mindestbestellmenge is used to notify the minimum order quantity for the PZN.
MPG | Medical Devices Act
MPG regulates the implementation of EU regulation 90/385/EWG for active implementable medical devices, 93/42/EWG for medical devices and 98/79/EG for in-vitro diagnostic products on a national basis.
MwSt – Mehrwertsteuer | VAT
The IFA attribute Mehrwertsteuer is used to display the percentage of VAT applicable to the product.
NEM – Nahrungsergänzungsmittel | Food Supplement
The IFA attribute Nahrungsergänzungsmittel – NEM is used to notify food supplements according to NemV.
NemV | Food Supplement Act
Nahrungsergänzungsmittelverordnung – NemV regulates which food stuff are defined as NEM and states approved substances. Moreover it provides specifications on notification and disposal of NEM.
Netzgesellschaft Deutscher Apotheker mbH – NGDA develops and runs the pharmacy server at pharmacists' and other market participants' disposal in reference to FMD 2011/62/EU and the delegated act (EU) 2016/161.
NTIN – National Trade Item Number
The IFA attribute NTIN is used for medicinal products to display the National Trade Item Number. This 14-digit number for medicinal products coats a German PZN.
NV – nicht verkehrsfähig | Non-Marketable
The IFA distributive state nicht verkehrsfähig – NV is used to notify products that have lost their marketability. They must not be marketed, remaining quantities in the market must not be sold.
Packungsgröße | Packaging Size
The IFA attribute Packungsgröße is used to display the product's packaging size with Menge und Einheit (quantitiy and unit). It refers to the so-called Verbrauchereinheit for which the PZN has been assigned to.
PackungsV – Packungsgrößenverordnung
The IFA attribute PackungsV is used to display to what extent pharmacy-only or prescriprion-only finished medicinal products are subject to the German Packungsgrößenverordnung.
Together with Allgemeine Verwaltungsvorschrift, PackungsV is used to determine and notify Packungsgrößen according to § 5 PackungsV along with the annex (especially annex 1) for medicinal products within panel doctors' care.
Pandemieartikel | Product Type
The IFA product type Pandemieartikel is used to notify products that are used in case of a pandemic possibly in co-operation with authorities.
PAngV | Price Indication Ordinance
The IFA attribute Preisangabenverordnung – PAngV is used to notify whether the product is subject to the price indication ordinance and thus a base price will be displayed.
The ordinance regulates that the total (price per unit according to PAngV) and base price will be displayed to the customer (i. e. the price of 100 g).
Patentablaufdatum des Originalarzneimittels
The IFA attribute Patentablaufdatum des Originalarzneimittels is used to display the date for medicinal products with bezugnehmender Zulassung als Generikum (generic medicinal products according to § 24b Abs. 2 AMG).
PEI – Paul-Ehrlich-Institut
PEI – Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel – is a federal institute within the health ministry promoting quality, effectiveness and security of biomedicinal products through research and examination.
Pflanzenschutzmittel | Plant Protections Products
The IFA attribute Pflanzenschutzmittel is used to notify approved plant protection products used to protect crops and their harvest.
PHAGRO is the stakeholder of pharmaceutical wholesalers in Germany.
pharm. Großhandel | Sales Information
The IFA attribute pharm. Großhandel is used to notify that the product is sold through pharmaceutical wholesalers.
Phytopharmakon | Phytopharmaceutical Product
The IFA attribute Phytopharmakon is used to notify registered or approved plant-based medicinal products containing as active agent(s) herbal extracts/preparations only.
PNR – Pharmazeutische Unternehmernummer
The IFA attribute Pharmazeutische Unternehmernummer – PNR is used to display the number of the pharmaceutical entrepreneurs according to AMG if he/she is not the medicinal product's supplier at the same time.
PPN | Pharmacy Product Number
The IFA attribute PPN is used to display the Pharmacy Product Number enabling the worldwide one-to-one use of the PZN or any other national product number.
The 12-digit PPN begins with the 2-digit PRA-Code followed by the 8-digit PZN and a 2-digit check sum.
Thus, the PPN serves implementing the FMD. Further information on the PPN can be found here: IFA CODING SYSTEM.
PPU | Wholesale Price PPU
The IFA attribute Preis des pharmazeutischen Unternehmers – PPU is used by the pharmaceutical entrepreneur/supplier of a prescription-only medicinal product to display the individually fixed price if it does not equal the agreed/assigned level of reimbursement. In this case it is notified as APU. PPU does not contain VAT.
PRA Code | Product Registration Agency Code
As Issuing Agency, IFA issues a PRA-Code for each national numbering system operating in the pharmaceutical sector.
Pro Generika e. V. is a German generics and biosimilar companies' association. It aims at an affordable and sustainable supply of medicinal products.
The IFA attribute Produktbezeichnung is used to display the product name with maximal 26 characters including spaces. It corresponds with the product name and contains - if necessary - abbreviations. The Produktbezeichnung is displayed in capital letters without special characters or umlaut.
The IFA attribute Produktname is used to display the product name with maximal 50 characters. It corresponds with the detailed name and is oriented at the SPC/MA or product information.
PU | Pharmaceutical Entrepreneur
For medicinal products requiring a marketing authorisation or registration, the pharmaceutical entrepreneur is the holder of the marketing authorisation or registration. The pharmaceutical entrepreneur is also any person who places medicinal products by parallel distribution or otherwise on the market under his/her own name, with the exception of the cases provided for in Section 9 sub-section 1, sentence 2 AMG (German Drug Law).
PZN der Klinikpackung | Reference
The IFA attribute PZN der Klinikpackung is used to display the PZN of the clinic pack when notifying a component so that a reference between the two PZNs will be visible.
PZN des Originals | Reference
The IFA attribute PZN des Originals is used to display the PZN of the original product when notifying re- or parallel imported medicinal products so that a reference between the two PZNs will be visible.
PZN des Voranbieters | Reference
The IFA attribute PZN des Voranbieters is used to display the PZN of the medicinal product with the same marketing authorisation of the former supplier so that a reference between the two PZNs will be visible.
PZN des Vorgängers/Nachfolgers | Reference
The IFA attribute PZN des Vorgängers/Nachfolgers is used to display the PZN of a published successor product when notifying predecessor. If the predecessor PZN is marked as discontinued, a reference between the two PZNs will be visible.
PZN – Pharmazentralnummer
The Pharmazentralnummer – PZN is a one-to-one id key within the German pharmaceutical market for medicinal products, medical devices and other health products (equivalent to the so-called pharmacy-typical goods).
It identifies a product (commercial form) with specific product identifying features of a supplier.
The PZN is used for internal and external communication such as i. a. supply chain, accounting of trading partners and the organisations within the healthcare sector.
PZN-Übertrag | Supplier Change
If a new supplier takes over the marketing of a product, product data may be passed on to the new supplier whilst retaining the PZN. This so-called PZN-Übertrag from one to another supplier is also called Anbieterwechsel.
The IFA attribute Registrierung gemäß § 9 Abs. 1 VerpackG is used to notify the number assigned to the supplier by Stiftung Zentrale Stelle Verpackungsregister. This 15-digit number indicates thats the manufacturer is registered with Zentrale Stelle Verpackungsregister according to Verpackungsgesetz (VerpackG) prior to marketing the packaging.
Schüttware | Product Type
The product type Schüttware is used to notify bulky packed goods, so-called Dosenware. It is used for manufacturing patient individual secundary blisters.
SDB | Safety Data Sheet
The IFA attribute Sicherheitsdatenblatt – SDB erforderlich is used to notify products for which a safety data sheet for hazardous substances is required or exists.
securPharm e. V. is a unique initiative to prevent falsified medicinal products from entering the legal supply chain. The initiative is sponsored by all major players in the pharmaceutical distribution chain in Germany and is responsible for developing a system to check the authenticity of medicinal products in Germany.
SGB V – Sozialgesetzbuch Fünftes Buch
Sozialgesetzbuch Fünftes Buch – SGB V contains provisions to health insurance (GKV). It regulates i. a. the organisation and services of the GKV.
The GKV as regulated in SGB V is described as community of solidarity whose aim it is to retain its members' health, restore or improve it.
Solitäres Fertigarzneimittel | Unique Finished Med. Prod.
The IFA attribute solitäres Fertigarzneimittel is used to notify medicinal products that are unique finished medicinal products according to the Leitfaden zur Definition des Generikaabschlags.
The notification is important to calculate the generic discount according to § 130a Abs. 3b SGB V (so-called Generikaabschlag).
Sperrfrist | Blocking Period
The IFA attribute Sperrfrist is used to determine the date of receiving data for data recipients and pharmaceutical wholesalers - ohne Sperrfrist (without blocking period) normally 10 respectively mit Sperrfrist (with blocking period) normally 5 working days prior to the publication date.
Standard | Product Type
The IFA product type Standard is used to notify products for which all other product types do not apply (i. e. Klinikpackung, Ärztemuster gemäß AMG).
steril | sterile
The IFA attribute steril is used to notify products that are free from viable microorganisms. Sterile products are marked as such on their outer packaging.
stiftung ear – stiftung elektro-altgeräte register
stiftung ear is the national register for waste electric equipment and was founded by manufacturers as their Clearing House for the purposes of the Electrical and Electronic Equipment Act (ElektroG). Entrusted with sovereign rights by the UBA, stiftung ear registers the producers of electrical and electronic equipment and coordinates the provision of containers for public exchange facilities and the pick-up of electrical and electronic waste equipment at the örE (public waste disposal authorities) in Germany.
T-Rezept-Arzneimittel | T-Prescription Med. Prod.
The IFA attribute T-Rezept-Arzneimittel is used to notify medicinal products that are may only be prescribed with a numeric two-piece form, a so-called T-Rezept, by BfArM in accordance with Arzneimittelverschreibungsverordnung (AMVV).
TFG – Transfusionsgesetz | German Transfusion Act
The IFA attribute dokumentationspfl. TFG is used to notify medicinal products that are subject to obligatory documentation according to TFG.
TFG regulates transfusion in general including extraction of blood, blood chemistry and blood products and their administration during blood transfusion in humans.
Tierarzneimittel | Veterinary Med. Prod.
The IFA attribute Tierarzneimittel is used to notify products that are meant for usage in or on animals only. Veterinary medicinal products are authorised finished medicinal products for animals according to AMG.
Tierarzneimittel-Abgabemengen-Register – § 47 Abs. 1c AMG
The IFA attribute § 47 Abs. 1c AMG is used to notify veterinary medicinal products that are subject to compulsory registration according to this article in AMG.
Pharmaceutical entrepreneurs and pharmaceutical wholesalers are obliged to notify medicinal products subject to this regulation that are dispensed to veterinarians.
Umweltbundesamt – UBA is the central authority for the environment, watching and evaluating the environment from different specialist disciplines.
UDI-DI – Unique Device Identifier
UN-Nr. | UN Number
The IFA attribute UN-Nummer is used to display the UN number for hazardous substances that are also hazardous goods (Gefahrgut).
Unterlagenschutz | Data Exclusivity
The IFA attribute Unterlagenschutz is used to notify medicinal products which underlie data exclusivity according to the Leitfadens zur Definition des Generikaabschlags.
This information is necessary to determine the level of reimbursement in accordance with § 130a Abs. 3b SGB V (so-called Generikaabschlag).
UVP | Recommended Retail Price
The IFA attribute UVP is used to display the recommended retail price (RRP). The price includes VAT.
Verbandmittel | Surgical Dressings
The IFA attribute Verbandmittel is used to notidy surgical dressings according to § 31 Abs. 1a SGB V. Thus surgical dressings are products including fixing material which main purpose it is to cover damaged surface areas of the body or to absorbing bodily liquids or both.
Verfalldatum und Laufzeit | Expiry Date
The IFA attribute Laufzeit is used to notify products with the sell-by date printed onto them or the outer pack (medicinal products cf. § 10 AMG).
The IFA attribute Verfall is used to display the storage life in months of the product from its production.
The IFA attribute Verifiz Pflicht ab Hochlade is used to display the date for prescription-only medicinal products that are subject to verification:
This gives the cutoff date from which the serial number for this medicinal product (PZN) marketed from the deadline 09.02.2019 according to FMD being uploaded into the system of ACS PharmaProtect GmbH (so-called Hochladedatum).
The IFA attribute Verifiz Pflicht ab Verfall is used to display the date for medicinal products subject to verification:
Sell-by date stating the batch separating the (first) obligatory verification goods from regular stock.
The IFA database contains different attributes in the scope of implementing the FMD and DVO to display information to identify medicinal products obliged to verification. These attributes are:
- Verifizierung im Pflichtbetrieb ab Hochladedatum
- Verifizierung im Pflichtbetrieb ab Verfalldatum
Verkehrsfähigkeitsstatus | Marketability
The IFA attribute Verkehrsfähigkeit is used to notify whether a product is marketable.
Veröffentlichungsdatum | Publication Date
The IFA attribute Veröffentlichungsdatum is used to display the publication date of the product in the systems of data users and data recipients. Publications may be on each 1st or 15th of the month (IFA-Redaktionskalender).
The purpose of the German Verpackungsgesetz – VerpackG is to prevent environmental consequences from packaging during its marketing, redemption and high-quality disposal.
Verpackungsart | Package Type
The IFA attribute Verpackungsart is used to describe the outer packaging of the consumable unit for which a PZN has been assigned to.
verschreibungspflichtig | Prescription-only
The IFA attribute verschreibungspflichtig is used to notify medicinal products or medical devices respectively that are prescription-only.
VfA is an economic association of the researching pharmaceutical companies in Germany.
WEEE-Reg.-Nr. DE | Reg. Nr. of stiftung ear
The IFA attribute WEEE-Reg.-Nr. DE is used to display the registation number of stiftung ear in accordance with ElektroG. This 8-digit number proves and with which number a manufacturer of an electric device, for which a PZN has been assigned to, is registered in Germany and thus the disposal of the device is taken care of.
Wirkstoff | Agent
The IFA attribute Wirkstoff is used to notify products that are active agents according to EU regulation 2001/83/EG Art. 1 Nr. 3a respectively § 4 Abs. 19 AMG.
Wirkstoffpatent | Active Substance Patent
The IFA attribute Wirkstoffpatent is used to notify medicinal products subject to an active substance patent in accordance with Leitfadens zur Definition des Generikaabschlags.
Zerbrechlichkeit | Fragility
The IFA attribute Zerbrechlichkeit is used to notify products that are fragile and call for special precaution during storage.
ZG – zurückgezogen | Withdrawn
The IFA distributive state zurückgezogen – ZG is used to notify medicinal products that were withdrawn from the German market by the pharmaceutical entrepreneur/supplier in reference to § 4 Abs. 7 of the currently valid Rahmenvereinbarung according to § 130b Abs. 9 SGB V. These medicinal products are permanently not available in the German market, remaining quantities in the market must not be sold.
ZU | Pre-Allocation
A pre-allocation may be done if the PZN is needed prior to the product data being published (i. e. to include it in brochures). Pre-allocated PZNs will not be published in the IFA Information Services.
Zulassung | Marketing Authorisation
The Zulassung in accordance with pharmaceutical legislation refers to finished medicinal products. It is the equivalent to an approval by authority and is the prerequisite to marketing of a finished medicinal product.
Zulassungs-/Registrierungs-Nr.
The IFA attribute Zulassungs-/Registrierungs-Nr. is used to display the medicinal product's registration number.
Zusammensetzung nach Art und Menge
The IFA attribute Zusammensetzung nach Art und Menge is used to notify the description of qualitative and quantitative information regarding the composition of medical devices (according to § 3 MPG) according to regulations (EU) 2017/745 and 2017/746.
The IFA attribute Zweckbestimmung is used to notify the description of the purpose of a medical device (according to § 3MPG) according to regulations (EU) 2017/745 and 2017/746.