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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 ist 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.
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.
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Informationsstelle für Arzneispezialitäten – IFA GmbH