Blog
New requirements for the labeling of high-risk medications
On January 19, 2024, the Chilean Public Health Institute (ISP) issued exempt resolution No. 459 approving guidelines and requirements for the labeling of high-risk medications. ...
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Security Update for DENOSUMAB Information
On November 7, 2023, the Public Health Institute of Chile (ISP) issued the exempt resolution No. 5855 instructing the update of information leaflets for healthcare ...
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Suspension of “Export Pharmaceutical Product Registration.”
On July 6, 2023, the Chilean Institute of Public Health (ISP) issued decree No. 1932, wherein the health authority suspends service code 44112130 “Export Pharmaceutical ...
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Technical guide of recommendations on labeling of cosmetic products
On April 21, 2023, the Chilean Public Health Institute (ISP) issued Resolution No. 1020 authorizing the “Technical guide of recommendations on labeling of cosmetic products”. ...
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Technical guide of requirements for the sanitary registration of allergens
On February 20, 2023, the Institute of Public Health has published the “Technical guide of requirements for the sanitary registry of allergens”. In this document, ...
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Guide to Good Manufacturing Practices (GMP) for medical devices in Chile
Through exempt resolution No. 106, dated January 17, 2023, the Chilean Institute of Public Health through the Department of the National Agency for Medical Devices, ...
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Obligations for license holders of oral contraceptive products
On November 30, 2022, the Institute of Public Health has issued resolution No. 5250 that complements resolution No. 2198/2022 that established the obligations addressed to ...
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Modifies the exempt resolution No. 395/2022, of the ISP, incorporating a term to make the labeling required to be updated in the renewal of the sanitary registration of pharmaceutical products.
Modifies the exempt resolution No. 395/2022, of the ISP, incorporating a term to make the labeling required to be updated in the renewal of the ...
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New requirements for oral contraceptives
Considering the alerts issued by the health authority regarding contraceptives, on June 6th, 2022, resolution No. 2198 (May 19, 2022) was published in the official ...
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Update of the list of reference products for demonstration of biosimilarity
On November 16, 2021, the Ministry of Health has issued the Exempt Decree No. 62 that modifies the exempt decree No. 945 that approves the ...
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Alignment in relation to the condition of sale and graphic labeling of medicines
Exempt Resolution N°395 On March 8, 2022, the Institute of Public Health has issued exempt resolution No. 395, instructing the Department of the National Medicines ...
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New Form for Reporting Events Supposedly Attributable to Vaccination or Immunization (ESAVI)
Exempt Resolution N° 521 On March 18, 2022, the Public Health Institute has issued exempt resolution No. 521, approving the ESAVI notification form based on ...
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