Pharmaceutical

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 …

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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 …

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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 …

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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 …

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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 …

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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. 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 »

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 gazette, which instructs marketing authorization holders of oral contraceptives submit to the Institute of Public Health (ISP) a proposal that complies with differentiating by color between active and placebos tablets. …

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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 Agency, ANAMED, to consider rules regarding the graphic labeling of medicines.  Avoid legends related to the type of establishment that can market the product.  The approved sales conditions must be …

Alignment in relation to the condition of sale and graphic labeling of medicines Read More »