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 on these products, taking into account the provisions in article 10 of Supreme Decree No. 3 in which it classifies pharmaceutical specialties according to their nature, specifically within biological products, in letter g) of article 12 where allergens are indicated as: “a biological product, intended to identify or elicit a specific and acquired modification of the immune response to an allergizing agent.”
According to the nature of these products, the authority points out that the application must be entered through the ordinary procedure since this is the correct one for biological products.
You can review the complete guide by clicking here.
Source: www.ispch.cl
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