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The Public Health Institute of Chile (ISP) has published Exempt Resolution No. 1889, which amends the “Guideline for the Regulation of Labeling and Packaging of Narcotic and Psychotropic Pharmaceutical Products,” originally approved in May 2024. This amendment responds to concerns raised by the Industrial Association of Pharmaceutical Laboratories (ASILFA) regarding the applicability of certain requirements …

Amendment to the Guideline on the Labeling of Narcotic and Psychotropic Drugs to Clarify Packaging Requirements Read More »

The Chilean Public Health Institute (ISP) has issued Resolution Exenta No. E679/2025, establishing an internal procedure for the application of a reliance mechanism in the granting of marketing authorizations for biological pharmaceutical products. This mechanism will allow products approved by at least two high-surveillance regulatory agencies (such as the FDA, EMA, MHRA, among others) to …

New Procedure for the Granting of Marketing Authorizations for Biological Products Read More »

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. In the document, the authority instructs holders of sanitary registration for parenteral solutions of large volume, small volume, and injectables used in anesthesia, intensive therapy, and individual hospital emergencies as …

New requirements for the labeling of high-risk medications Read More »

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 professionals and patients regarding pharmaceutical products containing DENOSUMAB as the active ingredient in their composition. In the update required by the ISP, the incorporation of safety information regarding the possibility …

Security Update for DENOSUMAB Information Read More »

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 Product Registration.” The context for the suspension of this service is framed within the opinion No. E272988 of the General Comptroller of the Republic, in which the oversight entity states …

Suspension of “Export Pharmaceutical Product Registration.” Read More »

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, the Chilean health authority provides the guidelines regarding the background information required for allergenic products in order to facilitate the correct presentation, ensuring that applicants provide complete and updated information …

Technical guide of requirements for the sanitary registration of allergens Read More »

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 holders of oral contraceptive products, consisting of active tablets and placebos. Initially, Resolution No. 2198/2022 established that oral contraceptives consisting of active tablets and placebos must be made up of …

Obligations for license holders of oral contraceptive products Read More »

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. On July 26, 2022, the ISP has issued the exempt resolution No. 3292 that modifies resolution No. 395, incorporating a term of 1 year from …

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. Read More »