- The AstraZeneca didn't sought approval of the Halix plant, approval seems to be a fast process.
- They seem to be meant for export.
Which makes me wonder if maybe all of the Halix plant production is meant for export (speculation 1) and if maybe they intentionally didn't seek approval of the plant because of reasons like this making all vaccines produced there "not valid for consumption in EU" and (maybe, speculation 2) "not neccessary to be listed when reporting to the EU" and (maybe, speculation 3) "not affected by any export controls because they are not valid vaccines".
Be aware that I think speculation 1 is likely but 2 and 3 get increasingly less likely. It can be as simple as saving a buck by avoiding regulative control on a plant which isn't meant to produce for the countries doing the regulation anyway.