There is a small legal interpretation that suggests that the authority that currently exists should be expanded to cover the biologics manufacturing centre production capacity, which, once operational, will be up to two million vaccine doses per month. The interpretation is that even though there's not a specific quantity threshold tied to the current authority, the two million doses per month is sufficiently large that it would be above a typical threshold for clinical trials, for example.
On May 17th, 2021. See this statement in context.