Brazil Compliance: 5 Best Practices for Success in Phase 1 and Beyond

If you do business in Brazil, there are just seven months left before you must comply with this year’s Phase 1 deadline. For Phase 1, manufacturers must serialize at least three batches of product, work with wholesale distributors and dispensers to track it through the supply chain, and then report on all movements by December 10. Here are 5 best practices to insure success for Phase 1 but also for the long-term.

#1: Look towards the full Brazil requirements to inform your short-term plan

Think of Phase One as the first step towards the long-term compliance requirements, and not just a pilot or proof of concept. There isn't enough time between phases to do things in 2015 that are not scalable in the future: the Phase 2 deadline is just 12 months later. That includes your solution architecture. Settle now on the system you will use for this year, next year, and years to come.

#2: Leverage existing facilities

When you begin phase one product selection, consider any facilities investments you may have already made. If you can choose a product that's already on a packaging line with serialization capabilities, that will reduce initial work.

#3: Minimize quantity

Pick products for which you can do a minimum commercial quantity batch. While you cannot just do a special quantity one batch, you do have flexibility to select products with smaller batch sizes and shorter production times.

#4: Shorten your supply chain

Assess your network and try to find a product for which you can minimize the number of product movements. Can you pick a drug that ships in large quantity to a wholesale distributor, and then find a pharmacy chain or a hospital chain that will, in turn, take a large amount? The end goal is to minimize the number of partners that you have to engage with in order to complete the full cycle in time.

#5: Ship product in July to be ready for December

In order for product to move through the supply chain to the dispenser and be ready for government reporting by December, it needs to be serialized and shipped in the July timeframe.