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