Russian Federal Law No. 425-FZ, the law requiring serialization in Russia, gives pharmaceutical companies until January 1, 2020 to be fully compliant. This means pharmaceutical companies have less than a year and a half to comply with the most complex serialization requirements to date – without the Russia Serialization requirements fully established and written.
What We Do Know:
While it is unknown how the requirements for serialization in Russia may change over the next year, pharma companies who wish to sell their products in Russian markets cannot rely on there being another delay for the deadline. To ensure they can sell in Russia, companies must start to prepare for Russia serialization now.
The requirements that have been put forth by the Russian government are some of the most complex serialization requirements yet. Currently, companies who wish to sell their products in Russia after January 1, 2020, need to make sure their products are traceable at a unit and a batch level from the creation and packaging of the product to the dispensing of the product. Beyond unit-level traceability, Russia has many requirements surrounding the aggregation of a product. Russia will require special reporting and documentation surrounding the disaggregation and aggregation of units and batches.
While many serialization requirements for other regions – such as the EU FMD or the USA DSCSA – require only prescription medication to be serialized and traceable, Russia’s regulation requires all medication to be serialized and traceable, including over-the-counter medications. This is a major departure from the global status quo, and a departure that producers of over-the-counter medications are not prepared for.
What Pharma Companies Need to Do:
Companies that have not started preparing for Russia serialization need to start immediately. The uncertainty surrounding the final regulations means that pharma companies need to be prepared for anything – their serialization solution needs to be agile and flexible.
Due to the comprehensiveness and complexity of the serialization requirements, companies need to be able to produce the type of data Russia will require, as well as be able to produce serialization data for all of their products, including over-the-counter products. Companies that have not yet started converting their production lines need to do so immediately if they wish to sell in Russia.
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To learn more about Russian Pharma Compliance click here.
