FAQ

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.

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. 

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.

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

Single Market Packs (SMP) without Blue Box:
According to DR, 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 DR 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 the database. If it is stated on the pack, "BLUE BOX" requirements apply.

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.