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FAQ

The following FAQ (Frequently Asked Questions) consist of recurring questions to IFA GmbH. They are grouped under a topic and followed by their answer. If your question is not mentioned, please do not hesitate to contact us directly.



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Information on Notification Order Documents

When do I need a cover sheet for my order?
A cover sheet is needed for orders submitted via fax or postal mail to IFA GmbH.
Why do I have to fill in so many attributes when I only wish to receive a PZN for my product?
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 specifiactions. 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 are 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.
May I hand in 'Zulassungs-/Registrierungsunterlagen' late?
The regular deadline applies to the publication of medicnal 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.
Does IFA GmbH provide photos of the products' packs for pharmacy software providers?
No, the information from IFA's Database are on economical, legal and logistical attributes of medicinal products and pharmacy-typical goods and do not contain any photos.
To which date can I terminate my contract with IFA GmbH?
IFA's Supplier Contract may be terminated by either side with a time limit of thee months to the end of each calendar year in written form to the other partner.

Basic Data

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): 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.
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 treated. The pharmaceutical entrepreneur creates a serial number during the packaging process and uploads it into the databank system of the pharmaceutical industry of ACS PharmaProtect GmbH. 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.

Further information on verification can be found in the FAQ on IFA Coding System.
Can pharmacies or pharmaceutical wholesalers order Ärztemuster?
No, Ärztemuster cannot be ordered by pharmacies or pharmaceutical wholesalers.
Which documents and attributes do I have to submit for the first publication of physician samples into IFA’s Database?
In general, notifying physician samples is not treated differently to medicinal products of the type standard. The following documents have to be submitted:

- Fachinformation (SPC)
- Proof of MA/registration (if date is within the last six months of notifying the product)
- completely filled in excel file Auftragstabelle für Neuaufnahmen or
form B1 – Neuaufnahme ArzneimittelThe 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
What is the PNR and which role does it play in IFA's Information Services?
The PNR is the number of the pharmaceutical entrepreneur assigned to the entrepreneur upon its first application by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

It is used in IFA's Information Services within the scope of implementing the FMD. The PNR must only be notified to IFA GmbH if the supplier is not the pharmaceutical entrepreneur according to AMG. To submit the PNR with the address data of the pharmaceutical entrepreneur (address of the legal entiry) and add it to the PZN in concern, please email the PNR to ifa@ifaffm.de. The PNR will be transmitted to ACS PharmaProtect GmbH exclusively with IFA's Information Services.

Price Information

Do I need to pay extra attention to prices of clinic packs?
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.
Are there any regulations regarding prices of other pharmacy-typical products?
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.

Legal Information

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 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.

Additionally, MA documents are used to legitimate the notifying supplier.
Why do I have to include product information when notifiying orders of
The product information is used i. a. to:

The specifiactions 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 specifiactions 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 Apothekenpflicht, the product information must be added to the order for further inspection.
What special rules apply to the marketing of sterile medical devices?
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.
For what purpose can I state the producer of Nahrungsergänzungsmittel, if it is not the supplier?
Stating the producer's address for Nahrungsergänzungsmittel is used for a transparent country of origin.
Does the supplier need to notify the Melderegister number of the UBA to IFA?
Please notify your product’s Melderegisternummer of the UBA for publication in the IFA database if the following applies:

 You are supplier of a product with a compulsory notification according to Batteriegesetz (BattG).
 You received an 8-digit Melderegister number upon compulsory notification from the Umweltbundesamt (UBA).
The product was marketed for the first time in Germany by you or a different supplier.
Which law regulates the return of batteries and accumulators?
Batteries and accumulators are obliged under Batteriegesetzes (BattG) and not under Elektro- und Elektronikgerätegesetz (ElektroG).
Do I need to notify the WEEE-Reg.-Nr. DE number to IFA GmbH?
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.
Should I register a stiftung ear Registrierungsnummer (WEEE-Reg.-Nr. DE) for all electric appliances?
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
- ElektroG/ear: yes, the manufacturer of the product underlies the obligatory registration with stiftung elektro-altgeräte register (stiftung ear) according to Elektro- und Elektronikgerätegesetz (ElektroG)
What is the purpose of the attribute WEEE-Reg.-Nr. DE in the IFA Database?
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.
What purpose serves the attribute Verbandmittel gemäß § 31 Abs. 1a SGB V for data users?
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.
Where can I find information on whether my product is a Verbandmittel gemäß § 31 Abs. 1a SGB V?
§ 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.
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 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.
Where can I find the UN-Nummer for my product?
The UN-Nummer is stated on the Sicherheitsdatenblätter (safety data sheet) for products with hazardous substances.
Can I notify a UN-Nummer for my product even though it does not have a Sicherheitsdatenblatt (safety data sheet)?
Yes, if the product is a hazardous substance.

Generic and Manufacturer Discount

What is a solitäres Fertigarzneimittel?
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.
What is a Generikaabschlag?
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.
How do I notify if the manufacturer discount is credited by AMNOG agreement according to § 130 b paragraph 1 sentence 4 of SGB V?
You can notify this by entering the value 1 for "yes" into column "Ablösung § 130a (1/8) SGB V“ of the EAD complete file.

An incorrect manufacturer discount has been charged for my medicinal products. How do I change that?
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 form B1, > 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 ABDATA 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.
I do not understand the charged manufacturer discounts. Which law regulates manufacturer discounts?
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

Sales Information

What do the abbreviations mean in connection with the distribution channels?
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
What should be considered when choosing the status discontinued?
A product is labelled as discontinued (AV), the item is removed from the market and will not be re-supplied. However, stock may be sold-off. The discontinued status is permanent and irreversible.

Products with a temporary delivery discontinuation or inability to deliver should remain on the market unless the production has ceased.
I'm a manufacturer of a product published in the IFA information services. Why can’t I change the data of my product without approval of the listed supplier?
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 (supplier change). 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.
What considerations are necessary during a supplier change?
A supplier change will only be processed if there is an order from the new supplier and the approval of the old supplier are handed into the IFA. Both, already published as well as pre-allocated PZN´s can be switched. It is also possible to switch only a number of PZN´s.
Why is a manufacturing/wholesale licence required?
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.
Can the distributor be named?
No, the distributor cannot be named. The phone number, fax number and email address of the distributor can be stored.

Data Recipients

Which information is provided from the IFA information services?
We maintain additional information for each PZN. A broad overview is offered in forms – please check website Notification Order Documents. If you need further information, send an email to IFA GmbH.
Which data format does IFA GmbH use to supply data?
You receive the data in ASCII-Format.
Can the IFA data be processed directly?
No, IFA supplies raw data.  They must first be processed using software programming.
Do the IFA data contain information about ingredients and use?
No, this information is contained within the ABDATA data.
How is the data subscription cost calculated?
If and under what conditions the data delivery is available depends on the business type and the nature of the intended data use.
How do I extract ZIP files?
ZIP files can be zipped/extracted with the aid of zipping programmes.

Both Windows and Mac OS X have their own zipping programmes. Alternatively, zipping programmes can be found online.

Pharmazentralnummer – PZN

May a PZN's leading zero be omitted?
No, due to the fact that the PZN (including check digit) is an 8-digit number.
How can a confusion between a PZN barcode and an encoded 8-digit GTIN (EAN-8) be ruled out?
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.
I want so sell my product through pharmacies. Under which conditions can I receive a Pharmazentralnummer (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.
Can I choose a PZN?
No, due to the fact that the PZN is a neutral identification key. It is generated automatically.
Is it possible to reactivate a deleted PZN?
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.

Counterfeit Protection (FMD) | IFA Coding System

L E G A L B A C K G R O U N D
 
Where can I find further information on implementing the FMD in the IFA database?
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 here: Informationen zur Umsetzung der FMD in der IFA-Datenbank.
Where can I find the legal background on verification?
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 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.
Do clinic packs need to be verified?
Yes, clinic packs of medicinal products obliged to verification must be verified.
Do clinic components need to 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.
Are physician samples obliged to FMD?
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.
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 not obliged. However, physician samples obliged to verification must be affixed with the DMC including the 4 data elements
(produkt 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.
What consequences does the effective date 09.02.2019 have for pharmaceutical entrepreneurs and other groups affected?
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.
Are there any security features?
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.
Of what does the unique identifier consist?
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.
Where can I find information on the anti-tampering device?
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).
What happens to packs not bearing the security features?
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.
What is securPharm e. V.?
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.
What is ACS PharmaProtect GmbH?
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.
What is EMVO?
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.
What is NGDA?
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.
 
I F A C O D I N G S Y S T E M
 
Does the serial number have to be randomised?
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.
Do I have to affix the serial number in clear print onto the pack?
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).
Does the Data Matrix Code have to bear the emblem PPN (or NTIN)?
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.
Can a pack bear more than one Data Matrix Code? If so, how do I recognise the relevante code?
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.
Does the trial period's pack layout differ from the later layout?
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.
May I omit the PZN in Code 39 on the outer pack upon changing to the Data Matrix Code?
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.
Where on the pack does the Data Matrix Code have to be affixed?
Positioning is neither regulated in the FMD 2011/62/EU nor the Delegated Regulation (EU) 2016/161. The pharmaceutical entrepreneur determins the positioning due to the pack's layout and printing cirmumstances.
Since when is the Data Matrix Code mandatory?
According to the delegated act (EU) 2016/161, the deadline 09.02.2019 is mandatory for all medicinal products obliged to verification.
Does the PZN have to be affixed onto the pack?
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.
Where on the pack does the PZN have to be affixed?
Generally the PZN may be affixed anywhere on the pack. For centrally authorised medicinal products, the PZN must be placed in the blue box.
Does the pack of medicinal products have to bear a national reimbursement number?
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.
Does the PZN have to be in the Data Matrix Code as fifth element?
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.
How do single market packs and multi market packs have to be marked with and without blue box?
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.
How do I have to code multi market packs meant for the German and Austrian market?
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.
What clear print requirements are there for German-Austrian multi market packs?
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).
How do I notify the master data for German-Austrian multi market packs?
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.
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 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.
What is the difference between a GTIN and an NTIN?
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.
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 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.
 
I F A N O T I F I C A T I O N
 
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 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.
Where do I find the MAH-ID needed for applying to ACS PharmaProtect GmbH or EMVO respectively?
The MAH-ID is the 5-digit IFA-Adress-Nummer (IFA address number). It is not to be confused with the IFA-Kunden-Nummer (IFA Customer ID), which is used for communication between IFA and suppliers exclusively. Your company's IFA-Adress-Nummer can be found in the supplier's address data.
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 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
Which attributes must be notified to IFA GmbH regarding the implemented FMD on medicinal products obliged to verification and from what point in time is it possible to do so?
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).
What does notifying the attribute 'Verifizierung im Pflichtbetrieb ab Hochladedatum' mean – when and how do I notify it?
With the attribute Verifizierung im Pflichtbetrieb ab Hochladedatum the pharmaceutical entrepreneur determins the medicinal product's obligation to 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?
What does notifying the attribute 'Verifizierung im Pflichtbetrieb ab Verfalldatum' mean – when and how do I notify it?
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?
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 or ACS. 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.
What happens if I do not notify the attributes for my medicinal products obliged to verification 'Verifizierung im Pflichtbetrieb ab Hochlade-/Verfalldatum'?
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.
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 attributes Verifizierung im Pflichtbetrieb ab Hochladedatum and Verifizierung im Pflichtbetrieb ab Verfalldatum.
Why do I have to notify both attributes 'Verifizierung im Pflichtbetrieb ab Hochladedatum' and 'Verifizierung im Pflichtbetrieb ab Verfalldatum' to IFA GmbH?
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.
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 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.
What purpose does the 'PNR' in the IFA Information Services have?
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.

Unique Device Identification (UDI)

What is UDI?
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.
What is a basic UDI (BUDI)?
A Basic UDI-DI (BUDI) is a key for grouping medical devices of a manufacturer that show the same specific features. These features include in accordance with "MDCG 2018-1 v2 Guidance on BASIC UDI-DI and changes to UDI-DI" their intended purpose, risk classification, basic structure and manufacturing properties. With the help of the Basic UDI-DI and via the databases, the joint reference to the products with regard to the documentation, specifically to the certificates, is to be created.

In principle, the Basic UDI-DI is composed of the following four elements (substring elements):
- Issuing Agency Code (IAC)
- Manufacturer Code
- Device Group Code
- Check Digits

To generate the Basic UDI-DI, the manufacturer assigns the code for the product group. IFA provides the manufacturer with the method and the additional elements.
What is a UDI-DI?
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.
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, 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.
What is EUDAMED?
The EU Commission shall set up a central database (EUDAMED) for medical devices according to Article 28 MDR.
Why should I register UDI data in EUDAMED?
According to the MDR, a basic UDI must be assigned to all medical devices except custom-made and performance study/investigational devices and added into EUDAMED with a UDI-DI and UDI-PI of all devices according to Article 29 paragraph 1, 4 MDR before placing it on the market.
From what point in time do I need a UDI-DI for my medical device?
With the date of the MDR's application on 26.05.2020, a UDI-DI must be assigned to each medical device. For in vitro diagnostic medical devices, this goes from the application of the IVDR (delegated act (EU) 2017/746 for in vitro diagnostics dated 05.04.2017) on 26.05.2022. An exception to this are custom-made devises and investigational devices. IFA, designated by the EU Commission as UDI-issuing entity on 06.06.2019, enables you to use PPNs as UDI-DIs. IFA's Specification UDI Use of the IFA Coding System for MD and PPN-Code Specification for Retail Packaging describe how the PPN serves as product identification called for by the MDR.
From what point in time do I need to mark my medical device with a UDI-DI?
Depending on the class of the medical devices, the UDI carriers must be placed on the label within one to 5 years from 26.05.2020 according to Article 123 (3) point f MDR. See FAQ No 6. of EC's document "Unique Device Identification (UDI) System under the EU Medical Device Regulations 2017/745 and 2017/746" for details. IFA's Specification UDI Use of the IFA Coding System for MD and PPN-Code Specification for Retail Packaging describe how the IFA Coding System serves as product identification called for by the MDR.
How can I use the PZN in order to place the UDI on the label?
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.
How do I define the UDI-PI?
In accordance with the requirements regarding certain medical devices the manufacturer defines the characteristic(s) suitable for product traceability.
From what date do I have to register UDI data in EUDAMED?
On 30.10.2019, the European Commission has stated on its website that it will only be possible to make EUDAMED operational once all EUDAMED modules achieved full functionality. EUDAMED’s joint launch for medical devices and in vitro diagnostics shall be incorporated from May 2022. The commission’s statement can be found here under the headline: What is the state of play of the implementation of EUDAMED? The date of the MDR’s application remains unchanged 26.05.2020.
From what point in time do I have to a notify UDI-DI with IFA?
IFA will introduce, depending on EUDAMED's functionality, UDI attributes and notify you in advance accordingly.
Are there special requirements for me when I use my PPNs as UDI-DIs?
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.
I have notified my medical device with IFA already. Do I have to register additionally with EUDAMED?
Yes, due to IFA currently not forwarding data to EUDAMED.
What is to be considered when coding UDI?
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.
Is the Basic-UDI-DI required on the label?
No, the Basic UDI-DI does neither appear in clear text nor in the Data Matrix Code. It is only used in EUDAMED as a key to product groups.
Who assigns the UDI-DI?
The manufacturer has to contact one of the issuing entities named by the European Commission. IFA GmbH is one of these issuing entities. By pre-allocating a PZN by IFA, the UDI-DI in the form of a PPN is automatically assigned to the device. This does not cause any further licence fee.
Who assigns the UDI-PI?
The manufacturer assigns the UDI-PI in accordance with the requirements of the MDR regarding traceability (cf. IFA Specification UDI).
Is a specific format required for the expiry date?
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.
Is a specific format required for the date of manufacture?
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.
I am a manufacturer of medical devices that will be sold through pharmacies and chemists. What do I have to do if chemists and supermarkets possibly cannot scan the DMC?
Currently, these products usually bear an EAN code. The PZN is usually in clear print and additionally encoded in Code 39. For MDR conformity, these products must bear the DMC in accordance with IFA's specifications for retail packs.
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