Following the implementation of the European Directive 2011/62-UE concerning security devices on the packaging of medicines for human use, there is a wide range of regulations that are still coming out and which are affecting the pharmaceutical market.
What is certain is that each regulation has its own requirements that differ from previous regulations: usually, they use other codes, the information to be included in the codes is different from one country to another, they have different grading requirements, and in some cases, they have durability requests, etc …
Code printing technology has also evolved dramatically, together with the different requirements that have been appearing in different markets. At the beginning, for expiration date and batch printing, thermal printing or embossing was sufficient. Subsequently, the inkjet, the technology widely used across the pharmaceutical industry, allowed medicines to be codified with Datamatrix. After that, the Chinese market came out with the implementation of 1D codes. Initially, this new method seemed simpler, however it was later found out that the technology used on the market was not the best option.
Nowadays, codes have become far more difficult, as they have to be more complex to be more secure. In the meantime, laboratories have to deal with the technology initially implemented to code their products for markets, all with very different requirements.
Therefore, now that the codification for the Chinese market has completely taken over the industry (some with more difficulty than others), the Russian Federal Law No. 425-FZ comes into force this year, and with just as many requirements than the previous ones.
The law was actually intended to be implemented in 2019, but due to its complexity, its implementation has been postponed until 2020. Unlike the FMD of the European Union, Russian federal law requires the unique identification of all medicines, including OTC (Over The Counter) and also includes other special requirements for aggregation and batch separation, which means a second Datamatrix in the packaging.
The Russian government has decided that the identification code must be a 2D Datamatrix that meets the standards of ISO / IEC 16022-2008, with an error correction of ECC-200.
One of the most important characteristics regarding the printing of the 2D codes of this legislation is the inclusion of encrypted data, which multiplies the information to be included in the code and makes printing more complex, with a high grading, particularly when it relates to laser printing on packaging. In this case, as in the case of the Chinese 1D code, the coding technologies that are implemented in the packaging lines of laboratories are not the most suitable for achieving the degree of readability required in the regulations. (This has been set to C in accordance with ISO / IEC 15415-2012). This is one of the reasons why the pre-serialisation of the folding carton is one of the most optimal solutions.
In addition, another argument to outsource serialisation to the supplier is that the printing of Russian codes on the packaging lines also reduces dramatically the packaging speed and therefore the efficiency on the lines. On the other hand, batches for the Russian market are usually not as large as, for example, those for China. Therefore, changes in the line and set-up of the packaging equipment to print this code takes up time that only impacts a few units, which significantly impacts the production ratios.
From our experience, there is no single solution for the codification of the different markets. The complexity provided by the different regulations affects the efficiency of the packaging lines and ultimately, it is about finding the balance between efficiency, complexity and cost. If you need more information about the pre-serialisation of your products, do not hesitate to contact us, we will be happy to help you!