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 to primary packaging, which is often difficult to label—such as ampoules, vials, and blisters.
Specifically, the new resolution clarifies that the requirement to include the statement “Subject to Control of Narcotics/Psychotropics” and the five-pointed star (red or green, depending on the type of product) must be applied mandatorily to secondary packaging. However, these graphic elements may also be included on primary packaging when its design allows it.
These changes aim to ensure proper interpretation of the graphic requirements established in Article 19 of the relevant regulations, thereby aligning the Guideline with current legislation. This clarification is particularly important for stakeholders in the pharmaceutical industry, as it avoids ambiguous interpretations regarding the type of packaging to which these requirements apply.
You can access the full document at the following link.
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