On September 30, 2020, Exempt Resolution No. 3422, dated August 25, 2020, of the Institute of Public Health (“ISP”) was published, which instructs holders of health registrations, and applicants for such registrations, to declare the plant species of the starch used as an excipient in the pharmaceutical products containing it in their formulation.
As of that date, the qualitative and quantitative formula expressions of all the pharmaceutical products applying for a health registration, which contain starch in their formulation, must expressly state the vegetable species from which the starch comes, and also state the byproducts that come from modified starch. All this, in the special form indicated by the resolution.
Likewise, in the case of products already registered, the holders of such registrations shall have until September 30, 2021, to comply with the aforementioned, and shall submit to the PSI the information of the vegetable species from which the starch comes, in the special form indicated by the resolution, including the starch by-products that are indicated.