- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
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*With our services, marketing authorizations are achieved in the countries where we operate, we provide regulatory services, we do not manufacture products
The technical-scientific entity in charge of evaluating the sanitary registries of medicines in Chile is the Public Health Institute of Chile (ISP), through the National Medicines Agency (ANAMED) department.
All pharmaceutical products imported or manufactured in Chile, to be distributed or used for any reason in the national territory, must previously have a sanitary registry.
The sanitary registry of a pharmaceutical specialty consists of a process of evaluation and systematic study of its pharmaceutical, pharmacological, toxicological and clinical properties, aimed at verifying its quality, safety and efficacy, which translates into a registration in a special role with correlative numbering. maintained by the Institute, which enables and authorizes its distribution and use in the country.
Pharmaceutical specialties, according to their nature, are classified as:
To request a health registration in Chile, it is required that you be a natural or legal person residing in Chile.
At Aruna Asesores we have local allies who can provide Holder services and local professionals who are experts in regulatory affairs who accompany those interested in entering the Chilean market in the formulation of strategies and process management to achieve the commercialization of the products.
Check with our professionals online or get frequent questions about registration processes in different countries
Check with our professionals online or get frequent questions about registration processes in different countries
