For years the OTC medication manufacturers got to look on from the sidelines as prescription pharmaceutical companies scrambled to meet DSCSA and other global requirements for pharmaceutical legistlation. In hushed corners of rooms, deep down there may have been concern that these regulations would bleed out into other arenas, but it wasn’t until early 2017 that the concern became a reality.
As with most news in 2017 – it was about Russia.
Russia’s announcement was similar in look and feel to most other legislation, except that it included 100% of medicines. Yes, that includes OTC – previously untouched by any track and trace legislation globally. It also mandated that it be completed by 1/1/2019 – or only two months later than the enforcement date of DSCSA legislation. That is going to require a Herculean effort for OTC manufacturers – many of whom were blindsided by the announcement, and still may be in a bit of denial to its reality.
Since the initial announcement, Russia has gotten a bit more realistic and changed the date to January 2020 – but that still is less than two years, and as any prescription pharma company can tell you – that isn’t a lot of time; especially when many of them are still vying for the attention of Optel, Antares, Adents, Bell & Howell, and others to become compliant themselves.
There isn’t a lot of time. If you’re an OTC and you ship into Russia, you must change. It’s that simple. What won’t be simple is how. Vision systems, product handling evaluations, equipment upgrades, and even packaging changes are all in your future.
The good news is – we’ve been there before. Domino is the preferred vendor for Serialized Pharmaceutical Marking and Coding, and we have a wealth of knowledge that’s available to you, and we are happy to share it. If your concern is carton board composition, we can help. If you want to know marking and coding options for labels, we can help. If you have a round bottle that needs a helper code, we can help with that too.
And if you don’t manufacture for Russia – our products are great for non-serialized codes, as well.
This news about Russia isn’t fake – but it shouldn’t be scary either. Let us help show you that.
Sector Manager – Life Sciences
Domino North America