Pharmaceutical companies in India, China, and Asia-Pacific Economic Cooperation (APEC) countries are already complying with serialization and traceability laws that mandate serialization and traceability. Most notable are the U.S. Drug Supply Chain Security Act (DSCSA) and the EU’s Falsified Medicines Directive (FMD).
Soon, however, Asian companies that want to do business in Russia will have to comply with that country’s new serialization requirements, which will be the most comprehensive in the world. The complex regulations go into effect on January 1, 2020, so companies that have not begun preparing need to start now.
To be compliant by the deadline, Asian pharma companies must do three things: assemble a dedicated project team, design and conduct a pilot phase, and find a trustworthy technology partner to help navigate the process.
Assemble a Dedicated Team
The road to compliance can be demanding, so it’s essential to have a dedicated team in place to maintain momentum and keep your plans on track.
Your team should be led by a project manager who is well-versed in the Russian regulatory landscape. They should also be skilled in appointing and managing a team that understands the importance of serialization. Your project team must have a comprehensive understanding of drug supply chains, including where ownership is passed from one party to another.
You must also have a clear vision of your IT landscape and data flow, and assign team members to be responsible for these facets of the process.
Design and Conduct a Pilot Phase
Conducting a pilot is crucial to make sure formal implementation goes smoothly. A pilot can uncover potential setbacks and provides a chance to discuss the functional requirements of being compliant. Importantly, Asian companies must ensure they have all the necessary equipment for labeling. For example, look at the needs for Data Matrix Codes and Electronic Data Interchange (EDI) labels, and assess if you’ll need an Electronic Document Management System (EDMS).
To launch a pilot phase properly, it’s also vital to have the right scanning equipment, cash software, and accounting systems, as well as a sophisticated IT solution. You should review what type of cash register and related software you’re using and verify how — and if — it will work with Russia’s new marking requirements.
Find the Right Technology Partner
When deciding on a technology partner to help meet regulation deadlines, be sure to choose one that has your best interests in mind. They must also be willing to work collaboratively to ensure flexibility to meet the final details of the Russia regulations, which have yet to be announced.
Your partner should be an experienced service provider that can adhere to tight timeframes, keep you in the loop about changing global regulations, and work with you to customize solutions that adapt to changes in the industry. Proactive, two-way communication is also a priority, and technical jargon should be kept to a minimum. It’s also important that your technology partner is committed to cybersecurity and data management, as you will be sharing large amounts of data.
Some Asian pharma companies may think it will be difficult to be ready for Russia’s serialization requirements (or any new pharma regulations). However, it’s a worthwhile investment in time and resources.
Russia’s pharmaceutical market is expected to reach $38 billion by 2021. Not complying with the new regulations would be disastrous for any Asian company’s bottom line, as they would be denied access to this lucrative market.
If you haven’t begun, there’s still time to be ready by January 2020. But you need to act now. Start by building your team, planning a pilot, and finding your technology partner. rfxcel can help you take the first critical steps. We have an experienced team in Russia, so contact us today to get started!