Health Authority seeks simplification of procedures

19 Apr 2016

The Argentine Health Authority (ANMAT) has launched a public consultation aimed at simplifying the registration of almost 30 pharmaceutical active ingredients. The list includes both nonprescription, referred to as “over-the-counter” (OTC), and prescription medicines.

The goal of the project is the unification of the technical assessment and the first batch authorization, so both requirements are performed in only one procedure. Please click here to see the project (only Spanish version available).

ANMAT estimates that, if the project is approved, the assessment time for some procedures would be reduced by 85 percent.

The rules proposed in the project would affect products containing the following active ingredients: amoxicillin, atenolol, cephalexin, ciprofloxacin, dexamethasone, enalapril, ibuprofen, metformin, paracetamol, salbutamol, acyclovir and ranitidine, among others.

The consultation is open to everyone. Should you require any further information, please contact us.




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