The European Union: Medicines Law and Space
How would EU medicines law treat a product made partly in orbit?
Chapter summary
with difficulty.
Key takeaways
- 1
EU good manufacturing practice assumes manufacturing within defined national territory, under human supervision and subject to inspection by the competent authority of a member state.
- 2
An analysis by the International Bar Association notes that orbital automation, limited human access and remote maintenance make these requirements hard to meet.
- 3
A product with an orbital step would need a manufacturing authorisation linked to a member state, a qualified person to release batches and an inspection approach for a site no inspector can visit.
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