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February 26, 2019
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April 2, 2019

Russia regulations: the next major pharma journey

The EU-FMD deadline has just passed and instead of time to take a breath and review existing practices, our industry now faces a new challenge with the introduction of the Russian regulations due to come into force in the very short timeframe of January 2020 (October 2019 for some products). Major changes will be required by all within the pharma supply chain – this includes processes and production – if you want to continue to sell products to Russia from next year.   

Russia: the detail

While the legislation in Russia has some similarities with the EU-FMD and other regions there are also some substantial differences. These differences, including item level coding using a cryptocode, full aggregation and a complex reporting system, mean that adapting existing serialization practice for these requirements will not be as easy as they seem from first glance.

In our recent webinar, we discussed Russia in detail, focusing on how companies will need to adapt existing processes further compared to the provision already in place for other traceability regulations. For instance, if coding is aligned to the requirements for European compliance, but Russia also requests additional elements such as the implementation of a cryptocode.

We also discussed additional requirements such as the data exchange mechanism in detail and the timescale for implementation, as this is tight for all businesses across the supply chain. During the webinar, we discussed the option of a two-step approach, both tactical and strategic, that would prepare pharmaceutical companies for future scenarios. This is a future-proofed tactic to efficiently adapt existing implementation to other markets that may introduce similar regulations in the future.

Excellis: we can be your guide

We take a holistic approach to all serialization challenges. Excellis Health has the right experience and expertise in the Russian market, including a strategic partnership with Russian-based services consultant.

If you missed our webinar, don’t worry.

Utilise our expertise through our webinar that we have released for access in our knowledge base. It talks, in more detail, about what these regulations mean in a practical sense for pharma companies. Access this recording of our webinar to understand more about the artwork changes, IT infrastructure, key production line improvements and reporting methods that will be key to success in Russia.

The tight deadline and clear scale of change needed across your production line and supply chain means that it is vital to understand your position and begin actioning changes today. We will be your guide access our webinar recording or email today.

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