ORBIS Compliance

Chile's Antimicrobial Medicines under new regulations: ISP imposes requirements to combat antimicrobial resistance

Published /Effective /Chile

The revised document corresponds to Exempt Resolution of the Chilean Institute of Public Health (ISP), which approves the technical document entitled "Updating the Labeling and Information Leaflets for Professionals and Patients on Antimicrobial Pharmaceutical Products as Part of the Antimicrobial Optimization Program (PROA)."

This regulatory instrument aims to strengthen the rational use of antimicrobials in the country and is part of a comprehensive strategy to address the spread of antimicrobial resistance.

The basis for this resolution is the growing threat posed by antimicrobial resistance, a phenomenon that impedes the effective treatment of multiple infections.

WHOM DOES IT IMPACT?

The direct impact is felt by manufacturers, importers, distributors, healthcare institutions, healthcare professionals, and patients.

CONCLUSION:

Exempt Resolution No. 646 represents a high-impact regulatory change in Chilean health policy, aimed at directly addressing antimicrobial resistance through mandatory regulatory measures that transform the way these medications are reported, prescribed, and administered.

Regulatory Authority

ISP

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Chile Quick Facts

Regulatory AgencySubsecretaría de Telecomunicaciones (SUBTEL)
Certification TypeMandatory
License ValidityIndefinite
Application LanguageSpanish
Legal License HolderNot required
In-country Testing RequirementNo testing required

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