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 that, according to article 101 of Supreme Decree No. 3/10, products intended for export are exempt from general requirements related to packaging, information, and labeling, and that export registration requests must evaluate all aspects of quality, safety, and efficacy of the drug, without restricting to a limited examination of aspects.
Given the above, products seeking registration for the sole purpose of export must therefore undergo an ordinary or simplified registration procedure, the latter procedure being valid only “…when dealing with a product manufactured in the country for the exclusive purpose of being exported, which, according to Chilean regulations, is considered a pharmaceutical product and can demonstrate that it is considered a food product in the destination country, the submission of information related to safety and efficacy may be omitted…” as indicated in article 52, No. 4, of Decree No. 3/10.
You can find Decree No. 1932 at the following link.
You can find the Comptroller’s opinion at the following link.
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