FAQ

As central service provider in the German pharmaceutical market and neutral clearing agency, IFA GmbH supports suppliers of medicinal products, medical devices and other pharmacy-typical products in complying with legal specifications. This includes complying with national and European specifications especially those according to § 131 paragraph 4 SGB V.

Against this background, the given information to IFA is the prerequisite for especially doctors, pharmacies, pharmaceutical wholesalers and health insurers to handle, use and bill the product correctly.

Thus each supplier aids a safe patient care and correct billing.

The regular deadline applies to the publication of medicinal products obliged to marketing authorisation or mandatory registration into IFA's Database. IFA's Publication Calendar states all deadlines for their equivalent publication date.

In individual cases, the necessary marketing authorisation or registration of medicinal products may be handed in by the deadline for product changes.

If the documents are not handed in in time, the publication of the medicinal product into IFA's Database is impossible.

No, the information maintained in the IFA database is economic, legal and logistical data on pharmaceuticals, medical devices and other pharmacy-typical goods. They do not contain image data.

IFA's supplier contract may be terminated by either side with a time limit of three months to the end of each calendar year in written form to the other partner: form for termination of the IFA supplier contract

The desired change affects one of the so-called artikelidentifizierendes Merkmal (product identifying characteric): Produktbezeichnung, Darreichungsform, Packungsgröße, Artikeltyp and the attribute Arzneimittel.

For the PZN to remain uniquely identifiable for the market participants at any time, product identifying characteristics must not be changed for published PZNs (cf Richtlinien für die Zuteilung von Pharmazentralnummern). In this case, a new PZN must be published.

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 treated. The pharmaceutical entrepreneur creates a serial number during the packaging process and uploads it into the European HUB. Before the pack is dispensed to a doctor, the pharmaceutical entrepreneur deactivates the serial number. Thus making sure that the pack may not be dispensed elsewehere. The PZN can remain the same for packs being used as physician samples during the production process. For packs that are used as physician samples exclusively, a PZN must be allocated.

No, Ärztemuster cannot be ordered by pharmacies or pharmaceutical wholesalers.

In general, notifying physician samples is not treated differently to medicinal products of the product type standard. The following product information/proofs have to be submitted:

• Summary of product characteristics (SmPC)
• Proof of MA – proof of registration (excerpt from AMIce database preferred)
  

   

The following notification channels are available:

• IFA portal
• IFA-Auftragstabelle B1 – First Publication Medicinal Product
  

The following entries differ from a medicinal product with the product type standard:

• Artikeltyp: Ärztemuster gemäß AMG
• Preisinformationen: no entries; without VAT
• Packungsgrößenverordnung (PackungsV): nicht betroffen
• all Vertriebswege: nein

Clinic packs are dispensed to hospital pharmacies or pharmacies supplying to hospitals exclusively. Thus notifying the KHAEP for medicinal products with the product type Klinikpackung suffices.

For clinic packs with a reimbursement Erstattungsbetrag nach § 130b SGB V notifying the APU § 78 (3a) 1 AMG is mandatory. Additionally, prices for APU and PPU may be notified. AEP, AVP, AEP PPU and AVP PPU remain without entry.

Medicinal products that are not apothekenpflichtig and other pharmacy-typical products are not subject to price regulations. For those, the prices KHAEP, APU, AEP and / or UVP may be calculated freely and notified as to the liking of the supplier. Notifiying the AVP is not allowed due to the fact that it is linked to the AMPreisV or a different price regulation.

Generally, only authorised (zugelassen or registriert) medicinal products may be marketed. Since the MA documents constitute proof of legitimate authorization or registration, they constitute the prerequisite for the marketing of a medicinal product. Thus the MA documents must be submitted with each first publication into IFA's Database of medicinal products obliged to authoristaion or registration.

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 possible the ones on the pack. This aids linking the product itself to its entry in the software and especially concerns specifications such as Produktnamen, Darreichungsform and Menge und Einheit (Packungsgröße).

The product information is also used to correctly classify the product for example Medical Device, Food Supplement, Biocidal Product etc.

For data changes regarding the legal classification or the attribute apothekenpflichtig, the product information must be added to the order for further inspection.

According to DIN 58953-8:2010-05, sterile medical devices should be delivered, transported and stored in a so-called packaging system, consisting of a primary (sterile barrier system) and an additional (non-sterile) outer secondary packaging (protective packaging).

This means that there are only two possibilities for the assignment of the PZN as follows:

1. PZN assignment for a single sterile medical device that is properly packed in a sterile barrier system and protective outer packaging.
2. PZN assignment for a protective package. The protection packing (e.g. the pack size 10 pieces) contains several sterile medical devices without individual protective packaging. The PZN should only be applied to the protective packaging, as the individually packaged sterile medical devices have no specific protective packaging.

Consequently, the PZN may not be used for sterile medical devices in a sterile barrier system without protective packaging.

Stating the producer's address for Nahrungsergänzungsmittel is used for a transparent country of origin.

Please notify your product’s Battery registration number by stiftung ear for publication in the IFA database if the following applies:

• You are supplier of a product with a registration obligation according to Batteriegesetz (BattG).
• You received an 8-digit Melderegister number upon registration obligation from stiftung-elektro-altgeräte register (stiftung ear).
• The product was marketed for the first time in Germany by you or a different supplier.

Batteries and accumulators are obliged under Batteriegesetzes (BattG) and not under Elektro- und Elektronikgerätegesetz (ElektroG).

Yes, please notify stiftung ear’s number (WEEE-Reg.-Nr. DE) in the following cases, so that it can be published in  IFA's Database:

• You are supplier of a product whose producer underlies the mandatory registration by stiftung elektro-altgeräte register (stiftung ear) according to Elektro- und Elektronikgerätegesetz (ElektroG).
• The product received an 8-digit WEEE-Reg.-Nr. DE by stiftung ear (www.stiftung-ear.de).
• You or another supplier (both underlying the mandatory registration) launch the product in Germany for the first time.

Yes, all products listed with “ja” in the following attributes should be registered with a Registrierungsnummer:

• ElektroStoffV: yes underlies regulation Elektro- und Elektronikgeräte-Stoff-Verordnung
• stiftung ear: yes, the manufacturer of the product underlies the obligatory registration with stiftung elektro-altgeräte register (stiftung ear) according to Elektro- und Elektronikgerätegesetz (ElektroG)

Participants of the pharmaceutical market can gather information from the attribute WEEE-Reg.-Nr. DE (Registry number of stiftung ear according to ElektroG) such as the number itself under which the producer of electronics, for which the PZN has been assigned to, is registered in Germany. And thus the return of the device is regulated.

Verbandmittel gemäß § 31 Abs. 1a SGB V may be prescribed or billed to the health insurer. Thus the correct notification is important to the supplier's interests.

§ 31 paragraph 1a SGB V defines a Verbandmittel. Further information on Verbandmittel and their circumscription to other wound care products is regulated through the Gemeinsame Bundesausschuss.

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 cases such as for example an accident.

Relevant people are obliged to obey hazardous substances legislation and technical regulations and to fulfil their vigilance obligation for hazardous substances. Upon receipt of the products, certain information must be available and recognisable in the data.

The UN-Nummer is stated on the Sicherheitsdatenblätter (safety data sheet) for products with hazardous substances.

Yes, if the product is a hazardous substance.

The attribute solitäres Fertigarzneimittel (solitary proprietary medicinal product) is used to notify packs of medicinal products that are excempt from the manufacturer's discount according to § 130a paragraph 3b SGB V (so-called Generikaabschlag). Further information can be found in the consensus guideline between relevant manufacturers' associations and the GKV-Spitzenverband.

A Generikaabschlag (generics discount) is the manufacturer's discount according to § 130a paragraph 3b SGB V. Further information can be found in the consensus guideline between relevant manufacturers' associations and the GKV-Spitzenverband. To identify packs of medicinal products affected by the Generikaabschlag, information from the notified attributes Wirkstoffpatent, Unterlagenschutz, biologisches Arzneimittel and solitäres Fertigarzneimittel.

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 of this change can be done in the IFA portal or in an EAD file EAD total. 

If value 1 is notified, the Datum, ab dem die Ablösung des Abschlags § 130a SGB V gilt must also be stated.

The manufacturer discount according to § 130a SGB V is calculated by ABDATA Pharma-Daten-Service with exception to the discount of vaccines. If and to what amount the generic discount applies, depends on the provided information (see IFA-Auftragstabelle B1 – First Publication Medicinal Product > Rechtsinformationen). Thus when in doubt about calculating the manufacturer's discount, these attributes should be checked first. For further questions on the calculation please contact your manufacturing association directly.

Please note that marking your medicinal product as generic according to § 10 (1) of Directive 2001/83/EC (German: Bezugnehmende Zulassung Generikum) does not result in a generic discount for the product.

The manufacturer discounts are regulated in § 130a SGB V for medicinal products billed to the GKV, and in § 1 AMRabattG for medicinal products billed to the PKV or civil services. You can find an overview to facilitate reading the paragraphes of § 130a SGB V:

Paragraph 1 manufacturer discount

• 7% discount for medicinal products
• 6% for generics and off-patent medicinal products
• 7% for OTC
• 7% for finished medicinal products in parenteral preparations
• 7% for outpatient treatment in hospitals

Paragraph 2 discount for vaccines

Paragraph 3 no manufacturer / vaccine discount for reference-priced medicinal products

Paragraph 3a price freeze

• No price freeze for reference-priced medicinal products
• Discount resulting from the price freeze will be charged in addition to the manufacturer discount and generic discount

Paragraph 3b generic discount

• 10% discount for generic and off-patent medicinal products
• Price cuts reduce the generic discount
• Generic discount does not apply to medicinal products 30% below reference price

(in addition to this please see faq What is a Generikaabschlag?)
...

Paragraph 8 discount contracts

• Manufacturer / vaccine discount can be credited on discount contracts
• Manufacturer / vaccine discount can also be credited on arrangements for a refund according to § 130 b paragraph 1 sentence 4 SGB V

The following abbreviations are used in the IFA documentation with the channels of distribution information: 

• KVA / Krankenh.Apo. // VWeg KVA – distribution to hospital pharmacies
• pharm. Großhandel // VWeg GH – distribution to pharmaceutical wholesale trade
• Apotheken // VWeg APO – distribution to pharmacies
• Einzelhandel // VWeg sonst. EH – distribution to other retail trade

A product is labelled as Außer Vertrieb – Marketing ceased (AV), the product is removed from the market and will not be re-supplied. However, stock may be sold-off. These products retain this distribution status until they are deleted and cannot be reactivated (see Richtlinien zu Artikelstatus und Statuswechsel and Change of product data).

Products with a temporary delivery discontinuation or inability to deliver should remain on the market unless the production has ceased.

Agreements between manufacturer and supplier can be very complex. It is impossible for the IFA GmbH to judge who possesses the rights in each and every case. Thus we only allow order forms from the currently listed supplier. In the case of a change in the distribution law, this must be made known to the IFA GmbH immediately from both sides ( PZN transfer to another supplier). If there are disagreements between the manufacturer and distributor, it is up to both to resolve them and inform the IFA GmbH accordingly. In both cases, the IFA GmbH requires consensual letters to take change orders in the future.

A PZN transfer to another supplier will only be processed, if both an order from the new supplier and the previous supplier's consent to the PZN transfer have been received. Both, already published as well as pre-allocated PZN can be switched. If individual PZNs are to be transferred, they must be named explicitly (see Change of product data).

A manufacturing authorization (Herstellungserlaubnis) according to § 13 of German Medicinal Products Act (Arzneimittelgesetz – AMG) is required by all entrepreneurs, that manufacture medicinal products commercially or professionally within the meaning of § 2 AMG. Manufacturing here includes the production, extraction, preparation and offering of medicinal products. This requirement applies to any company that is involved in any step of the production of medicinal products. This applies regardless of whether the company also acts as a pharmaceutical entrepreneur pursuant to § 4 (18) AMG - or as holder of the authorization or markets medicinal products under his name. Contract manufacturers which perform certain manufacturing steps on behalf of the pharmaceutical company, are also required to have a manufacturing authorization. A manufacturing license is required for the production of medicinal products which are not yet approved - e.g. for medicinal products that are used in a clinical trial (so-called investigational medicinal products) or other medicinal products which do not require approval. If you hold a Herstellungserlaubnis according to § 13 AMG, please send a copy thereof to us. For more information see: § 13 AMG.

A wholesale license according to § 52a AMG is required by all companies which trade in medicinal products either professionally or commercially. According to § 4 (22) AMG, trading involves the procurement, storage and sale or export of medicinal products. The transfer of medicinal products to clinicians, veterinarians or hospitals is exempted from this rule. Exceptions to this permit requirement are in the travel industry, gases for medicinal purposes, in the normal course of operation of pharmacies as well as in the context of purchasing groups. If you hold a Großhandelserlaubnis according to § 52a AMG, please send a copy thereof to us. For more information see: § 52a AMG.

No, the distributor cannot be named. The phone number, fax number and email address of the distributor can be stored.

The IFA information services include economic, legal and logistical data on medicinal products, medical devices and other pharmacy products. It does not include pharmaceutical information such as active ingredients, indications or ATC codes.

The data is output in ASCII format. Given that it is raw data, it first requires programming of the data.

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 adapt the data to their specific needs and requirements and to implement it, for example, in enterprise resource planning systems.

No, due to the fact that the PZN (including check digit) is an 8-digit number.

A PZN as barcode in Code 39 bears a PZN in clear print underneath the barcode: PZN - 12345678. The minus sign in front of the PZN is used as identifier and causes the reader to interpret the digits as PZN.

Receiving PZN and their publication requires the signing of IFA's supplier contract outlining the buisiness relations.

A PZN is issued while product data are being published in IFA's database. At the bottom of all this are IFA's guidelines that are aimed at the primary purpose - identifying products within the healthcare sector. IFA's guidelines IFA-Richtlinien für die Zuteilung von Pharmazentralnummern  line out the conditions for the publication of product data in IFA's database.

No, due to the fact that the PZN is a neutral identification key. It is generated automatically.

Notifying a product deletion leads to the product and its data being deleted from IFA's database and the systems of data recipients. A new publication of a deleted PZN is impossible.

Information on implementing the Falsified Medicines Directive 2011/62/EU (FMD) and its Delegated Regulation (EU) 2016/161 (dVO) in the IFA database can be found in Guidelines for Notifying Product and Address Data.

Legal background to verificationcan can be found here:

• Falsified Medicines Directive 2011/62/EU (FMD)
• Delegated Regulation (EU) 2016/161 (dVO)

Further information can be found here:

• FAQ of the EU Commission on Delegated Regulation
  
• Website of EU measures to protect patients against falsified medicinal products in the legeal distribution chain
• BfArM's and PEI's notice on anti-tamper device

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 products mentioned in the Black List are obliged to verification (currently medicinal products with the active agent omeprazole in two potencies). White and Black List can be found in the appendix of the Delegated Regulation (EU) 2016/161.

Yes, clinic packs of medicinal products obliged to verification must be verified.

No, clinic components (smallest unit of a clinic pack) may not be verified. Clinic packs of medicinal products obliged to verification, hoewever, need to be verified.

Yes, physician samples according to AMG are, if the medicinal product itself is obliged to verification, also obliged to verification. They must be serialised just like any other sales pack. All four data elements must be uploaded into the PU system. Prior to dispense, the physician sample must be checked out by the pharmaceutical entrepreneur. Thus OTC, non-prescription-only, physician samples do not have to be verified unless they are stated in the Black List.

There are three variants of physician samples for pharmaceutical entrepreneurs:
a) smallest sales pack with additional marking as physician sample (physician sample bears PZN of sales pack)

b) physician sample in unique pack (physician sample bears own PZN); package size equals the smallest sales pack

c) physician sample in unique pack (physician sample bears own PZN); package size smaller than smallest sales pack

For variants b) and c), product types physician sample will be published in the IFA Database with their own PZNs.

If a product is no longer subject to prescription, the verification obligation is usually also not required. The manufacturer is obliged to recall the product with the affected safety features and simultaneously inform IFA GmbH that the prescription obligation and the verification data have to be changed or deleted.

Only changing these attributes allows for smooth-selling of the OTC packages in the pharmacy. The simultaneous sale of products with and without safety features under the same PZN is not possible.

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 not obliged. However, physician samples obliged to verification must be affixed with the DMC including the 4 data elements (product code, serial number, expiry date, batch number) and their clear print information. Generally it is recommended to print the PZN in clear print since this eases usage and documentation in physician practice.

From the FMD's effective date 09.02.219, pharmaceutical entrepreneurs may only market medicinal products obliged to verification when the packs bear the two necessary security features. These packs are only dispensable after their successful verification.

The pack's security features of medicinal products obliged to verification are:
a) anti-tampering device
b) unique identifier, consisting of four data elements in the Data Matrix Code.

The unique identifier consists of:

a) product number
b) individual serial number
c) batch number
d) expiry date

It is used to check the medicinal product's authenticity and to identify individual packs. The data elements are printed onto the pack in a Data Matrix Code and generally in plain text. This information is uploaded by the pharmaceutcial entrepreneur into the PU system.

The anti-tampering decive, preventing interferance with the product, makes the first opening of the pack evident. Further information on the different options can be found on the website of the Deutsches Institut für Normung and the Europäisches Komitee für Normung (DIN EN 16679:2015-03).

Packs of medicinal products obliged to verification not bearing the security features made dispensable before 09.02.2019 remain as such until the end of their expiration date.

Packs of medicinal products obliged to verification marketed from 09.02.2019 onwards are only dispensable when bearing the necessary security features.

securPharm e. V., a non-profit-orientated organisation, as so-called National Medicines Verification Organisation, NMVO is responsible for the setup of the system to validate medicinal products in Germany. Pharmaceutical entrepreneurs must join securPharm's system in order to meet the legal obligation to notify the necessary data into the national database.

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 pharmaceutical market (PU system). In order to connect to their system, pharmaceutical entrepreneurs have to contact ACS PharmaProtect GmbH directly via email info@pharmaprotect.de or telephone +49 30 577037-900.

European Medicines Verification Organisation - 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. Pharmaceutical entrepreneurs affected by the FMD and registered with ACS PharmaProtect GmbH must also register with EMVO.

NGDA (Netzgesellschaft Deutscher Apotheker mbH) runs the pharmacy server aiding pharmacists and other market participants medicinal products' verification. Scanning each pack before its dispense verifies the authenticity of the pack through data exchange.

Yes, the Delegated Regulation (EU) 2016/161 requires randomising serial numbers. Pharmaceutical entrepreneurs are responsible for its technical realisation. securPharm coding regulations must be followed.

Yes, the Delegated Regulation (EU) 2016/161 requires the serial number in clear print. An exception can be made for small packs (sum of two smallest sides < 10 cm).

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 affixing the emblem may be found in securPharm's coding regulations for pharmaceutical companies.

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 and ignored by the system.

Medicinal products participating in the trial period affix PZN and Code 39 and a Data Matrix Code. Prior to 09.02.2019, the Delegated Regulation does not apply which is why it is at the pharmaceutical entrepreneur's discretion to affix clear print and the anti-temper device on packs in the trial period. The pack layout must be updated no later than 09.02.2019, so that all packs marketed from this date onwards bear the correct features.

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 V. The barcode, Code 39, must be affixed additionally at least until 09.02.2019.

If Code 39 is omitted from 09.02.2019, the PZN must be affixed with the label "PZN: " in clear print.

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 cirmumstances.

According to the delegated act (EU) 2016/161, the deadline 09.02.2019 is mandatory for all medicinal products obliged to verification.

Yes, even if the pack bears the product code as PPN or NTIN, the PZN is mandatory in clear print with the label "PZN: " since 09.02.2019.

Generally the PZN may be affixed anywhere on the pack. For centrally authorised medicinal products, the PZN must be placed in the blue box.

The delegated act (EU) 2016/161 (dVO) calls for a national reimbursement number or a national number (NN) to identify the medicinal product as unique identifier (UI) if demanded by the member state. For medicinal products in Germany, the legislation does not demand this in a UI. Thus the request in the so-called fifth element (NN) is not needed. In accordance with dVO, it suffices if the Data Matrix Code contains product code, serial number, expiry date and batch number.

Please note that legal regulations such as Arzneimittelgesetz (AMG), frame agreement accodring to § 131 SGB V, QRD templates and EU guidelines remain untouched.

No, since the PZN is embedded in both PPN and NTIN, there is no need in Germany to encode it as further (fifth) element. Multi country packs are a specialty because they do not contain the PZN within the product code. For those packs, the PZN must be included in the Data Matrix Code as fifth element.

Single Market Packs (SMP) without Blue Box:
According to dVO, the product code must be affixed close to the Data Matrix Codes. Germany permits PPN or NTIN as product codes. Both contain the embedded PZN. Printing the PZN as fifth element of the Data Matrix Code and in clear print with the label "NN: " is not necessary. According to the frame agreement according to § 131 SGB V, the PZN has to be included in the DMC and affixed in clear print with the label "PZN: " on the outer pack since 09.02.2019.

Packs with Blue Box:
The dVO does not state specific indications. Since the unique identifier (UI) cannot be linked to a country, the UI cannot be part of the blue box (neither Data Matrix Code nor clear print). The frame agreement according to § 131 SGB V calls for PZN identification in accordance with the "BLUE BOX" requirements within the box "Deutschland". PZN is to be affixed without "NN: " since it it not part of the UI (CMDh/201 - OUTER PACKAGING - #18 refers to the UI).

Multi Market Packs (MMP) with Blue Box:
The pharmaceutical entrepreneur determins which internationally unique product code to use to verify the pack. The product code and serial number are outside the blue box. For identifying further markets and reimbursement purposes, a nationally used product number is used. It may be affixed onto the pack or linked via tha database. If it is stated on the pack, "BLUE BOX" requirements apply.

Because the Austrian PZN is linked via the database with the pack's product code, it is not included in the product code of multi market packs. If the product code a GTIN given by the pharmaceutical entrepreneur, the German PZN must be encoded as fith element. This may be omitted if the pharmaceutical entrepreneur uses the NTIN as product code due to the embedded German PZN in the NTIN itself.

As for single market packs, the four elements of the unique identifier (UI) must be affixed in clear print adding the nationally predefined label. Please pay attention to the requirments of the QRD template "BLUE – BOX REQUIREMENTS" containing the national specifications. Thus the following applies for:

Germany:
PZN is to be affixed in clear print with the label "PZN: ".

Austria:
EAN code may be affixed.
Note: "EAN code" is equivalent to the GTIN containing the Austrian PZN (may be referred to as NTIN-AT).

The pharmaceutical entrepreneur on the one hand notifies the determined product code with the Austrian PZN to the Austrian Apothekerverlag for data connection. On the other hand it notifies EMVO the German PZN and the Austrian PZN with the product code for identification.

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 the technical level of coding which is explained in securPharm's coding regulations. When using the NTIN, the pharmaceutical entrepreneur must follow licence requirements of GS1. Using the PPN (additionally to the PZN) does not generate further costs.

The NTIN is a specific type of GTIN where existing national numbers, such as for example the PZN, are encoded in a way to make it internationally unique. The difference lies in generating the GTIN. With the NTIN the right of assigning lies with the issuing agency and not with the pharmaceutical entrepreneur. Using the NTIN does not create any difference. Since the NTIN is a full GTIN and does not technically differ, the application identifier (AI) "01" is used.

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 the form of PPN or NTIN. Additionally, the batch number and expiry date may be included. FMD does not allow to affix a serial number.

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 and to rule out so-called Bestandsware released packs for the market before the deadline 09.02.2019. Thus these attributes determine the unhindered release of Bestandsware.

Bestandsware (released prior to 09.02.2019) may have three versions:

• Type 1: without security features, thus no anti-temper device and no distinctive feature
• Type 2: with security features but without upload of data into PU system; serial numbers are unknown to the system
• Type 3: with security features and upload of data into PU system; the pack is FMD compliant

Both attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum must be notified to IFA GmbH for medicinal products obliged to verification. They are used to determine medicinal products' packs obliged to verification and rule out so-called Bestandsware (released packs from 09.02.2019).

With the attribute Verifizierung im Pflichtbetrieb ab Hochladedatum the pharmaceutical entrepreneur determins the medicinal product's obligation to verification. The pharmaceutical entrepreneur notifies the date of the first upload of packs obliged to verifications' serial numbers into the PU system. Typically this is the deadline 09.02.2019.

Per PZN this notification must be done once even if logically over time more and more serial numbers are uploaded into the PU system.

Information on how the notification should be done can be found in the FAQ:
How do I notify the attributes 'Verifizierung im Pflichtbetrieb ab Hochladedatum' and 'Verifizierung im Pflichtbetrieb ab Verfalldatum' for new publications after 15.02.2019?

The attribute Verifizierung im Pflichtbetrieb ab Verfalldatum depicts the shelf life of the first batch obliged to verification. It is used to distinguish dispensable so-called Bestandsware from packs obliged to verification.

If the expiry date in the pack's Data Matrix Code is before the notified date, Bestandsware is expected. If in doubt, the pharmaceutical entrepreneur notifies the latest possible expiry date: this is the deadline 09.02.2019 plus the medicinal product's shelf life added on top.

Information on how the notification should be done can be found in the FAQ:
How do I notify the attributes 'Verifizierung im Pflichtbetrieb ab Hochladedatum' and 'Verifizierung im Pflichtbetrieb ab Verfalldatum' for new publications after 15.02.2019?

First publications from 15.02.2019 have to if they:

1. were released by the pharmcaceutical entrepreneur / supplier from 09.02.2019 onwards and
2. are affected by the FMD, thus obliged to verification,

be produced FMD-compliant. I. e. packs bear the DMC according to the FMD. In those cases there is no Bestandsware. For those packs the verification attributes are to be notified as follows:

Attribute Verifizierung im Pflichtbetrieb ab Hochladedatum:
You will notify the deadline date of the FMD, 09.02.2019, because the reference to the deadline remains the same.
Thus the pharmaceutical entrepreneur / supplier determins the medicinal product as obliged to verification. All data uploads will be treated as obliged to verification by the so-called PU system.

Attribute Verifizierung im Pflichtbetrieb ab Verfalldatum:
By notifying this attribute, the pharmaceutical entrepreneur / supplier has the opportunity to prevent a third party from marketing non FMD compliant products suggesting that it would be Bestandsware. Thus the the pharmaceutical entrepreneur / supplier has to notify a date before the one stated on the DMC respectively affixed to the first batch's pack. I. e. the date 022019 can be notified.

EXCEPTION:
An exception is a first publication from 15.02.2019 onwards with the products already released by the pharmaceutical entrepreneur / supplier before 09.02.2019. I. e. you notify first publications of Bestandsware. The batches being released after 09.02.2019 must be produced FMD-compliant, bear a DMC. For those packs the attributes are to be notified as follows:

Attribute Verifizierung im Pflichtbetrieb ab Hochladedatum:
The pharmaceutical entrepreneur will notify the upload date of FMD-compliant serial numbers into the EU hub. I. e. the date may be after the 09.02.2019.  

Attribute Verifizierung im Pflichtbetrieb ab Verfalldatum:
The highest possible entry for this attirbute is the deadline date 09.02.2019 plus the shelf life of the affected medicinal product.

If the supplier fails to notify the attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum, logic check system processes in the market will act according to the data notified by the supplier. Incorrect or incomplete notifications may lead to packs that would be dispensable not being recognized as such and thus will not be dispensed. Notifying the above mentioned attributes is vital.

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 attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum.

The attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum are used to identify medicinal products obliged to verification as well as to distinguish these from the so-called Bestandsware, packs released prior to 09.02.2019. Thus these attributes aid the dispense of Bestandsware.

Generally, IFA GmbH transfers datas of PZN obliged to FMD at the time of their launch and first publication to ACS PharmaProtect GmbH. If the notification is done without a blocking period, data will be transfered 10 working days prior to the publication data (with blocking period: 5 working days). Serial numbers may only be uploaded into ACS's system after their knowledge of the PZN.

If you need more time to upload serial numbers, you may, upon PZN pre-allocation, ask IFA GmbH to transfer the data to ACS. A PZN pre-allocation will be transferred 10 working days prior to the next possible publication date to ACS PharmaProtect GmbH. Note: you will have to notify the PZN's first publication with IFA GmbH for the desired publication date in order to publish the data in IFA's information services.

PNR (Nummer des Pharmazeutischen Unternehmers - number of the pharmaceutical entrepreneur, assigned by BfArM) is used for internal purposes in relation to implementing the FMD. It is not issued as part of the IFA Information Services.

UDI (Unique Device Identification) is a system to uniquely identify medical devices worldwide according to Article 27 of the MDR (Regulation (EU) 2017/745 dated 05.04.2017). UDI is the broader term for a unique product identification consisting of the Device Identifier (UDI-DI) and the Production Identifier (UDI-PI). These items are described in Annex VI, part C of the MDR.

The basic UDI (BUDI) is the main key for grouping those products of a manufacturer that have the same properties. According to the guideline “MDCG 2018-1 Guidance on BASIC UDI-DI and changes to UDI-DI”, these properties include the intended purpose, risk class, essential design and manufacturing characteristics. With the help of the basic UDI and EUDAMED, the joint reference to the products with regard to the documentation, specifically to the certificates, is to be created.

In principle, the basic UDI is composed of the following four elements (substring elements):

• Issuing Agency Code (IAC)
• Manufacturer Code
• Device Group Code
• Check Digit

The basic UDI is generated by the manufacturer itself. For this purpose, the manufacturer forms product groups according to the above mentioned MDCG 2018-1 Guidance and denotes the Device Group Code for them. The method and further elements are described in the Specification Unique Device Identification (UDI). IFA GmbH provides the manufacturer with a BUDI Generator to calculate the check digit.
 
The basic UDI is not applied to the package and is not stored in the IFA database.

The UDI-DI (UDI Device Identifier) is a unique product identifier, which is assigned to the product itself or its packaging. For the use of the IFA Coding System, the PPN is used as the UDI-DI. The PPN represents the PZN in an internationally unambiguous format. When issuing a PZN, IFA also issues the PPN at the same time.

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, also the production date or a serial number assigned by the manufacturer. This applies also for reusable medical devices that are to be refurbished. For these common data elements, the internationally standardised data identifiers in accordance with the international standard ANSI MH 10.8.2 can be used. The IFA Coding System references this standard.

The EU Commission shall set up a central database (EUDAMED) for medical devices according to Article 28 MDR.

A published or pre-allocated PZN can be used uniquely identifying worldwide in the form of the PPN as UDI-DI. This way, the PZN is eligible for registration in EUDAMED.

In accordance with the requirements regarding certain medical devices the manufacturer defines the characteristic(s) suitable for product traceability.

The EU Commission informs on its website that the various modules for voluntary use will be made available step by step. Current information can be found here: https://ec.europa.eu/health/md_eudamed/overview_en. Date of application of the MDR remains 26.05.2021.

IFA GmbH has implemented a data field in which to report an UDI-DI. The UDI-DI of a different issuing entity can also be entered there.

No, because IFA guidelines already concur with the MDR. Please note that Appendix VI of the MDR calls for special issuing rules for UDI-DIs.

Yes, because your product data will not be forwarded to EUDAMED by IFA GmbH.

The UDI-DI (PPN) and the manufacturer's determined UDI-PI have to be included in compliance with IFA's Coding System in the Data Matrix Code. Any other data elements may be, but are not obliged to be, included in the Data Matrix Code.

No, the Basic-UDI does not appear in plain text or in the code. It is used in EUDAMED, certificates and documentation as a key for grouping products.

The manufacturer has to contact one of the issuing entities named by the European Commission. IFA GmbH is one of these issuing entities.

The manufacturer assigns the UDI-PI in accordance with the requirements of the MDR regarding traceability (cf. IFA Specification UDI).

Annex I, Chapter III No. 23.2. point i) MDR requires an unambiguous indication of the time limit for using the device safely. It includes at least the year and month, where this is relevant. In the code, the date format YYMMDD is provided.

No, the manufacturer decides according to QM-specifications if he expresses the date of manufacture in days or months. In the code, the date format YYYYMMDD is provided.