Evaluation of biological products
Through resolution N° 19/2013 ANMAT has announced that the evolution and resolution of the procedures involving products that contain active pharmaceutical ingredients from biological origin, as well as the ones classified as radiopharmaceuticals or radiopharmaceutical preparations will be responsibility of the Department of Biological Products of INAME. This department will also be in charge of the evaluation and resolution of the applications of manufacturing sites (located in Argentina and abroad)in the abovementioned products.
For proper and effective implementation of the provisions, the Department of Biological products of INAME will carry out certain changes in processes, and will also implement new internal operational instructions and procedures, together with adequate training of the staff involved.
Furthermore; new documentation such as application forms, guidelines and external instructions will be drawn up in order to be able to fulfill the new resolution.