The Guide to the Regulation of Labeling and Packaging of Pharmaceutical Products aims to improve the understanding of the specific regulation.
On june 28, 2024, the “Regulatory Guide for labeling and packaging of narcotic and psychotropic pharmaceutical products” was published in the Official Gazette by the Institute of Public Health (ISP). The purpose of the initiative is to generate a technical document that provides guidelines for a better understanding of the specific regulation.
This guide addresses the following aspects:
- General regulatory framework for narcotic drugs, psychotropic products and other substances that produce similar effects.
- The specific regulatory framework for each product.
- Recommendations and guidelines to the graphic requirements for these products.
This manual not only unifies the requirements for the labeling and packaging of these products, but also clarifies certain concepts and common doubts of users, incorporating new requirements.
An example of the latter are the labels on the containers of narcotic products, which must now state the condition of sale of the product and the legend in black letters on a white background.
In terms of recommendations, the minimum size of certain symbols, legends and colors are addressed, as well as the areas of respite in the packaging, among others.
Another example is the case of star colors. There are now three suggestions for the red star and four for the green star, and for the star itself, the minimum size it should have in relation to the package is indicated.
In conclusion, this guide provides information for the correct use of pharmaceutical products for both the patient and the personnel in charge.
If you have any questions, please contact our Public Law and Regulated Markets group:
Antonio Rubilar | Partner | arubilar@az.cl
Dafne Guerra | Life Science and Competition Director | dguerra@az.cl
Francisco Alarcón | Associate | falarcon@az.cl
Claudia Delgado | Associate | cdelgado@az.cl
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