Anvisa approves regulatory process proposal to extend the validity of the resolution on importation of radiopharmaceuticals
1 diciembre 2021


On December 1, the Collegiate Board of the National Health Surveillance Agency (ANVISA in Portuguese) approved the proposal for a regulatory process to extend the validity of the Resolution that establishes the criteria and temporary procedures for the importation of industrialized radiopharmaceuticals.

The regulation establishes that the products listed in the Normative Instruction, among which are various types of radiopharmaceuticals, and their updates, may be imported on an exceptional and temporary basis by public agencies and entities and by legal entities under private law, including health facilities and services.

It should be noted that the Resolution that provides for temporary criteria for the import of imported radiopharmaceuticals is still in force until December 31, 2021. What was approved today by the Collegiate Board is the proposal to open the regulatory process and study whether it is possible to extend the validity of such resolution.