When we receive a proposal to import a foreign supply, we always review it very carefully for the safety, quality and efficacy of the drug. That involves reviewing the instructions for use, the dosing and frequency, and understanding the formulation and the ingredients that are used, because although you may have the same active pharmaceutical ingredient, it may be packaged at different dosage levels, and the other ingredients that go into making a drug may also be different. The excipients may include dyes that are not normally used. In this case I'm thinking about children's analgesics in cherry flavour, for example, or grape flavour. We really need to understand those differences and make it clear what those differences are for parents and caregivers so they know those differences and can dose at the appropriate level for the age and weight of their children and take into account any allergies that their children may have before administering the drug.
The other thing that we look at is the manufacturing conditions used in the formulation and the manufacturing and fabrication of the drug. As Dr. Sharma referred to earlier, there is an international standard called “good manufacturing practices for drugs” that we adhere to, and we make sure that any drug that is placed on the market in Canada is produced under those conditions. That is everything end to end, from how manufacturers are storing the active pharmaceutical ingredients to the training of the employees they have on the production line, as well as how they clean the equipment, the credentials of the quality assurance person who is signing off on the batches before they are released to the market, right down through to the distribution chain, making sure that any requirements related to temperature, for example, are observed and that those drugs are in full compliance with all of the requirements needed for the market here.
Maybe Linsey will want to add to that.