Serialization in Small and Medium Pharma: How to get ready for European FMD

//Serialization in Small and Medium Pharma: How to get ready for European FMD

In less than a year, Europe’s Falsified Medicines Directive (FMD) will come into full effect, starting on 9th February 2019. This definitely implies a massive challenge for those entities in the small and medium side of the industry. But what does this really mean for the companies in pharma distribution?

Smaller and medium-sized companies in the Pharma Industry will have the choice to apply the needed serialization processes through an outsourced partner. To be sure that everything will comply with the FMD rulings, the partner will have to go thru a technical onboarding by the EMVO and passes through a series of steps involving documentation and verification checks. This process, however, can take several months, so taking action promptly is recommended to be able to market these products before the directive comes into place.

“Small and medium sized Pharma Companies needs agility and cost-effective solutions to remain competitive without compromises in their operation. That’s a big challenge when the countdown is running.” concludes Ariel Romero Diaz, Verifarma Head of Sales for EMEA.

One of the main issues for this part of the industry is the master data management and data exchange with contract manufacturing organizations (CMOs). For them, a solution familiar with a lower volume of production and specific target markets makes way for a quicker solution to sort through aspects such as traceability and FMD compliance.

Manufacturers should also be aware that delays in their serialization process without proper professional guidance could result in direct effect to the lines or production, from packaging lines to warehouses in pharma distribution. Many of them assume that the practice impacts only the first ones, but it demands many changes in automation and data handling that cannot be changed in such short notice, affecting several aspects in departments such as IT, engineering and logistics, among others.

Acquiring a specialized and previously authorized partner for managing your products’ EMVO data is extremely recommended as it will have enough time to process, therefore successfully avoiding any future issues in your production lines or track and trace solutions. To be sure to get enough time, the best choice is to go through a partner with working knowledge of both track and trace and FMD compliance, which will make the serialization of your products a quick and painless procedure to adjust your products to the new EU measures.

About Verifarma
Verifarma is a comprehensive and flexible Track & Trace solution for the pharmaceutical industry with more than 10 years of experience, optimized deployment processes and an unbeatable price. Our know-how on regulation is key to help you meet legal compliance on time and achieve prompt adaptation to regulatory changes while applying best practices and industry standards. Verifarma is an active member of Open SCS Working Group.
With active deployments in 15 countries, over 2,000 companies in the pharmaceutical industry rely on Verifarma for Serialization Levels 3, 4 and 5. Among leading Pharmaceuticals, Distributors, 3PLs, Pharmacies and Health Care Centers.