Anyone offering medicinal products in Russia faces complicated challenges. So-called serialisation and aggregation regulations come into force in October. Before then, METTLER TOLEDO wants to provide further assistance at a free practical forum.
A lot has changed in the Russian legal landscape since the beginning of the year: The Deadline for the entry into force of the recently announced regulations on 1 January 2020 was pharmaceutical manufacturers already known. However, at the end of 2018, the Russian government published a revised version of Federal Law No. 488-FZ. This update provides for an earlier entry into force of the provisions for medicinal products for the treatment of rare diseases (12 nosologies) as early as 1 October 2019.
METTLER TOLEDO informs on 9 July in Heppenheim on a free practical forum entitled „Russia Serialisation“ on the forthcoming law on drug safety and presents track & trace solutions that pharmaceutical manufacturers can use to ensure the safety of their products. Reliable serialisation and aggregation in the shortest possible time. During a subsequent evening event, participants and speakers will be able to exchange ideas and discuss open questions. Here for more information about this forum.
Russian requirements are particularly complex
The Difference The difference between the Russian requirements and serialisation regulations such as the EU Falsified Medicines Directive (FMD) or the US DSCSA is the complexity of the Russian requirements. Pharmaceutical manufacturers have to serialise every single with a crypto key and an individual cryptocode, which must be requested from the Russian authorities for each serial number via a web service or encryption hardware. The crypto code increases the security of the Data Matrix Code. printing data volume clearly.
The new law also requires the complete aggregation of all units, as well as a comprehensive documentation and reporting obligation for all logistical processes in the life cycle of packaging.
„Pharmaceutical manufacturers are facing rapidly approaching compliance deadlines and highly complex legal frameworks as the legislation is updated. In contrast to the EU regulations, which mainly apply to prescription medicines, the Russian regulations also affect a much broader range of pharmaceutical products, including over-the-counter medicines.“
Minthia from Wiarda, International Marketing Manager at METTLER TOLEDO
Source: METTLER TOLEDO
