On September 30, 2022, Exempt Decree No. 60.2022, of the Ministry of Health was published, which amends Decree No. 500, of 2012, which approved technical standard No. 136, “Standard that determines the active ingredients contained in pharmaceutical products that must demonstrate their therapeutic equivalence and list of pharmaceutical products that serve as reference thereof”, and Decree No. 27, of 2012, which approved technical standard No. 131, which “Defines the criteria intended to establish therapeutic equivalence in pharmaceutical products in Chile”, both of the Ministry of Health.
The modifications made by the Exempt Decree are as follows:
1. Regarding Technical Standard N°136, the following products were added to the “List of Reference Products for Therapeutic Equivalence Studies”:
2. A time period was granted until March 31, 2024, to comply with the requirement to submit therapeutic equivalence studies to the ISP for the following pharmaceutical products containing Active Ingredients or Association, under the form of release indicated in the Exempt Decree.
3. A “List of Products that without losing their Bioequivalent status in Chile, may be used as reference products for Therapeutic Equivalence studies” was added:
Regarding technical standard N°131, a series of “active ingredients or associations” with their solid pharmaceutical form, oral administration type of release, were added to the “List of non-new (mature) active ingredients with long experience of use”.