The international customers need to consider the risks, which are region-specific and mitigate them.
Regulatory & timeline risk
The timelines of registration despite having a powerful regulator (ANMAT), the registration dossier response can be unpredictable; local tests, dossier inquiries, inspections can postpone launching.
Currency/Inflation & FX risk
Argentina has a history of working during the periods of inflation and FX shock; the cost of imports, pricing and repatriation of profits can fluctuate.
- Price pressure and competitive local players.
Domestic companies control most of the segments that have good relationships; price controls narrow profit margins of premium products.
- Supply-chain/logistics risk
Production/ export can be hindered by import delays, the process of custom and bottlenecks in infrastructure and export logistics.
- IP and market access risk
In Argentina, although there is IP framework, this may not be actively enforced; international companies introducing biologics have to take into account biosimilar competition and biosimilar regulatory working-off licences.