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Although we live in a global economy, international regulations are not uniform. Navigating the constantly shifting environment of new markets requires knowledge, contacts and a fresh approach to product registration.
Determining Your Next Market
If we had a crystal ball we wouldn’t have to guess which markets to expand into. However, not knowing what the future holds makes it difficult to know where to allocate the resources for global expansion. Although we cannot predict the future, we can make smart decisions based on available information.
Distributor leaders often help to indicate expansion opportunities by expressing interest in new markets. Your distributor demographics are a strong indicator for where your business is headed. In addition, the DSA publishes an annual report on industry sales, providing a strong feasibility indicator of the markets in which your business can be successful.
Because registration costs are less difficult to control than the time to obtain the registration, it is advisable to start the process early. I have never been criticized for beating expectations. So, with these things in mind, identify future markets quickly, put together a list of potential in-country consultants, and book your flight.
Finding the Right Consultant
In the race to open a new market, time is of the essence, which makes selecting the right consultant critical. But what should you do when you have no knowledge of the markets or any contacts on the ground? The good news is that we are in an industry that is often open to helping one another.
The DSA has been a go-to source for first contacts in new markets for 4Life® in many instances. A recent experience with former DSA President Neil Offen illustrates my point. While Neil was visiting our office, I expressed frustration at the slow progress we were making on the product registration front in a particular country. Without hesitation he provided me with a lead that resulted in a number of capable contacts. Finding a consultant that has worked with companies who have products on the ground is proof of their competency.
Other industry associations have also proven to be valuable, not only in recommending registration consultants, but also in educating 4Life on changing regulations in that market. Being at the forefront of changing regulations and legislation can lead to a change in product registration strategy, saving months, if not years, in lost time and efforts.
For example, as a result of a regulation change in one country that allowed for a simplified notification process for certain categories of food, 4Life shifted its strategy for product introduction in that market, allowing us to take fewer risks up front and speed up the process.
Being at the forefront of changing regulations and legislation can lead to a change in product registration strategy, saving months, if not years, in lost time and efforts.
Consultants who offer solutions to obstacles as opposed to giving simple “allowed” or “not allowed” responses provide real value for direct selling companies. This ability to offer critical insight based upon current rules and regulations requires an intimate knowledge of the marketplace. A seasoned consultant will suggest proven alternatives or point you in a direction that is likely to result in an approval.
Big Firm or Boutique Shop?
Many times, legal advisors who start a new entity can also provide suggestions on product registration or may even offer that service themselves, but using a law firm to handle product registration is not our preferred approach. Although having a reputable law firm represent your company in other corporate aspects is advisable, we have found much success in employing former government officials and/or specialists to assist in the registration of products internationally.
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Not surprisingly, most ministry officials have a background in the sciences, (e.g., biology, chemistry, pharmacology and others) and prefer to work with others in their field. We have found that the common backgrounds get the process moving at a much faster rate. Put a chemist in front of another chemist and just sit back and watch—it is like reuniting long lost friends.
Bottom line: Know your audience and work accordingly.
Finding the Right Formula
More often than not, a company has to adapt to local regulations by adjusting a current product formula in order to gain approval. A commonsense approach that can improve operational efficiencies when attempting to launch a new product into multiple markets at once is to develop a formula that will work in as many countries as possible without compromising the integrity of the product. Creating a matrix with the formula components on one axis and the countries in question on the other will provide an at-a-glance view for a product development team of where to go next with product formulation. After a bit of research and some conversations with consultants, you will arrive at a formula that is likely to be accepted in multiple countries.
One misconception is to assume that because a certain product has been approved in one country, that a neighboring country is likely to approve it in the same manner. In most instances each country will require its own review and assessment. Even in cases where trade agreements exist or regulation harmonization is supposedly in place, we have rarely had a case where we were able to either register the exact same formula or use the same label.
Waiting Patiently, Albeit Aggressively
There is often a balancing act between respecting the timeline of a government agency’s response to a registration application and pushing to get a response. One cannot assume that because all of the required paperwork has been submitted that this means the file is being actively reviewed. Asking for expected timelines and holding officials to those timelines is not unreasonable. I firmly believe that if we did not follow up on certain registration submissions, they would not have been addressed for several months, if even addressed at all.
In the case of one market we have entered, a team member made several trips to simply sit at the Ministry of Health and wait for our files to receive review. As a result, ministry officials came to know her personally and saw that 4Life was serious about getting established in their country. It is difficult for anyone to ignore the sincere determination of a consistent and professional approach.
We have often seen results come simply as a consequence of making an appointment to meet with a ministry official or consultant. There is something compelling about knowing someone is traveling thousands of miles to check up on things. At times, the embarrassment of having to say that nothing has happened in the last number of months is more daunting to officials than simply approving the registration.
Getting to Know You
The overarching purpose of an official in any ministry of health is to protect the health and well-being of the people. With that in mind, familiarizing them with your company and products is the key to success. We have found that a regulator’s comfort level only increases after a face-to-face meeting. They want to know you and the company you represent. If they trust you, they trust the company. If they trust the company, they trust the products the company manufactures and distributes. While visiting the official in charge of reviewing your file should not be done in all cases, you should never rule it out as an option—meaning that at 4Life, there’s always a cost-of-travel that we associate with international product registration.
In the end, whether talking about field development, employee retention or product registration, this is a business focused on relationships. Relationships drive results—and results are what matter. We consistently see the best results coming from the people with whom we have the best relationships. Having solid relationships in place will enable a proactive approach to product registration, speeding up entry to market and allowing increased growth.
Danny Lee has been Chief Operations Officer at 4Life since 2008.
