3PL & Importation: Supporting your product commercialization through Importation
Whether you are looking for a partner to act as your Importer of Record, require support for a Drug Establishment License submission or adding your product to Innomar's DEL, or quality assurance support, Innomar Strategies can help you to gain access to the Canadian market.
Over the last 5 years as Innomar has expanded our 3PL service offering we've become the Importer of Record for over 15 companies. We've added dozens of site to our establishment license and those sites range from narcotics, biologics, controlled substances, as well as even natural health products. So it really covers a broad range, and those also range from countries that are mutual recognition countries, and those that are non-mutual recognition countries. So we have a lot of experience and a vast wealth of knowledge in terms of doing that onboarding.
The timeline considerations for adding a client to our establishment license really starts off by depending on whether the foreign site is in a mutual recognition country, or non-mutual recognition country. Canada – Health Canada does have agreements with certain countries, and if the foreign site exists in that country the timeline can be as quick as 180 days. If it's a non-mutual recognition country it's going to be a little bit longer, anywhere up to 250 days.
When we're onboarding a client or onboarding these sites onto our DEL (Drug Establishment License) often times we need to get all of the documentation together and do our initial application. Once we do that Health Canada has a 20-day screening period by which they look at all of the documentation. If everything checks out they will give us a file number. That file number becomes very important to you, because you must wait 90 days before you can then do your new drug submission, and you must cite that file number. So there is a real sequence of events that needs to happen and it all starts with the DEL application.
So yes, customers can choose to switch to their own DEL after initially using Innomar as their importer. They can use Innomar as their importer in the early stages to gain early access to the Canadian market, but then after their business grows they might decide to obtain their own DEL.