On December 23, 2022, Exempt Resolution No. 2748 of December 2, 2022 was published in the Official Gazette, approving the technical guide of requirements for the sanitary registration of phytopharmaceuticals (hereinafter the “Technical Guide”).
This Technical Guide has its origin in the need to regulate the sanitary registration of phytopharmaceuticals, in view of the particularities of this type of pharmaceutical products and their differences with products of chemical origin.
The substantive content of the Technical Guide is as follows:
1. It provides a glossary of fundamental definitions to understand phytopharmaceuticals.
2. It explains the way in which the generic denomination and formula expression of phytopharmaceuticals should be carried out.
3. It specifies the way in which the antecedents must be presented to obtain the sanitary registration. The different information modules that must be complied with are explained:
a. Module 1: Administrative information.
b. Module II: General summary.
c. Module 3: Quality. The products must comply with the Regulation of the National System of Control of Pharmaceutical Products for Human Use, specifically with Article 32 of the same.
d. Module 4: Non-clinical information.
e. Module 5: Clinical information.
Since this is a Technical Guide published in the Official Gazette, it is fully in force for the industry, so it is pertinent that companies working with phytopharmaceuticals and especially those seeking to register such products in Chile pay special attention to the requirements and formalities of the same.