Changing the product codes
According the Falsified Medicines Regulation, the 2-dimensional code should be introduced by 9th February 2019. It is, however, still not agreed upon whether the current linear barcode should not be allowed from the same date. This is an ongoing discussion with the Norwegian authorities.
When switching from the linear barcode to the 2-dimensional code, it is further recommended to change the product code from National Trade Item Number (NTIN) to GTIN (Global Trade Item Number). The GTIN is the preferred product code as it is a lot more flexible than NTIN. If you stick with NTIN, you are at risk of having to change the commodity number (Vnr) whenever you are making a change to the pack.
Both the NTIN and the GTIN can refer to the same six digit Vnr. Currently, in 2017, the wholesaler and pharmacy systems can only recognise either an NTIN to a Vnr, or a GTIN to a Vnr. A system update on 1 Jan 2018 will allow the system to recognise that several NTIN or GTINs relate to the same Vnr, and this is important for the implementation of GTIN. The system will recognise the so called 1:n relation (one-to-many relation).
When the system recognises that a NTIN refers to one Vnr as a different GTIN, it will be allowed to have the product code as a NTIN in the linear barcode, and a GTIN in the 2-dimensional code. Again, this is only allowed from 1 Jan 2018.
It is important to note that this combination of NTIN/GTIN is not allowed in Sweden and Finland, so for packs shared with these countries, the linear barcode could be switched to GTIN when introducing the 2-dimensional code, or you should remove the linear barcode as you introduce the 2-dimensional code on 9 Feb 2019.
The Norwegian Medicines Agency (NOMA), has published a Q&A document saying that the linear barcode is not allowed on the pack after 9 Feb 2019. Senior Advisor Inge Johansen in the Association of Pharmaceutical Industries in Norway (LMI) says that this poses a big challenge for the industry, particularly for manufacturers with many packs. It is an enormous task to coordinate the removal of the linear code over night for the industry, and we are in talks with the agency to see if this requirement could be leveraged, says Johansen.
For ease of use, Nomvec has prepared visual graphics (one pager) of this information available for download.
– If the requirements from the Norwegian agency changes, Nomvec will change the visual representation as well, says Johansen.