11/12 March 2020
The introduction of a Europe-wide serialization system (often simplified to "Track & Trace") has brought great challenges to pharmaceutical manufacturing companies. Since February 9, 2019, serialization has been mandatory for certain human medicinal products (essentially prescription medicinal products and a few OTCs) throughout Europe. Nevertheless, there are still problems in many countries. Indeed, a number of pharmaceutical companies and also certain EU countries haven't yet been able to establish the necessary infrastructure (IT systems, hubs, etc.).
In addition, many countries outside Europe are preparing serialisation systems. In the USA, China, India and many other countries, initiatives have been launched with different time scenarios and implementation procedures. Internationally speaking, Russia is already very far advanced. Unfortunately, the requirements and the ways of implementation are very different in the various countries. For this reason, the ICRMA has published recommendations on the implementation of Track&Trace for medicinal products.
On 25 December 2018, Federal Law No. 488-FZ was adopted. The Russian legislator had already published various documents and launched a pilot programme on "Track&Trace". Federal Law 488-FZ came into force on 1 January 2019 already. Requirements for certain "important medicinal products" have been in force since 1 January 2019, and from 2020 these requirements are to be extended to all medicinal products. Russia would thus establish a standard that is more comprehensive than in that of the EU, since not all human medicinal products in Europe have to be identified with the 2D matrix code.
In Russia, as in many other countries, the implementation is still facing major problems. However, the pressure from the legislator is very strong. In Russia, one wants to establish a system (often abbreviated to "FSIS DCM") which is technically demanding. Thus, as in Europe, a data matrix code is to be used for identification. Nevertheless, in Russia, unlike in the EU, a so-called crypto code is planned, which requires considerable technical implementation.
In Russia, the new crypto code will pursue several goals at once. Of course, counterfeit cases (which have also significantly increased on the Russian market) have to be contained. Many serialization systems have this goal. However, the serialisation system in Russia goes much further than in other countries. The government is hoping for extensive monitoring of the pharmaceutical market and supply chain. In this way, the system should make prices for medicinal products transparent. This will make it possible, for example, to monitor price limits for certain medicinal products. Unlike the systems in many other countries, Russia has to monitor the entire flow of goods.
All companies that manufacture medicinal products for the Russian market must adapt to the new requirements. The legal requirements for Track&Trace in Russia are available in English on the website of the Chestny Znack (National Track & Trace Digital System). You will also find FAQs as well as further information and contact details.
Learn more about the implementation phase and the experiences since February 9, 2019 of Track&Trace in the EU as well as about Track&Trace in other countries such as Russia at the ECA Academy conference Track&Tace in Prague.