The Brazilian Health Regulatory Agency (ANVISA) postponed the deadline of two public consultations, regarding sanitary control of pharmaceutical services and technical requirements on clinical laboratory activities. They seek to improve regulatory quality.
The Brazilian Health Regulatory Agency (ANVISA) postponed the deadline of two public consultations regarding amending proposals on health services, covered in the last Regulatory Report edition. They are presented as follows:
Public Consultation n. 911/2020 presents an altering proposal to RDC n. 44/2009, related to Good Pharmaceutical Practices for the sanitary control of pharmaceutical services (operation, dispensation and commercialization). The main goal is to update and uniform regulatory provisions, covering topics such as terminology, notification systems and removal of method restrictions. The public consultation also presents an AIR. More information is available here (in Portuguese).
Public Consultation n. 912/2020 aims at expending the role of RDC n. 302/2005, which regulates clinical laboratories, in order to incorporate technical requirements on activities related to Clinical Analysis Tests (TAC, in the Portuguese acronym) and Diagnostic and Therapeutic Support Services (SADT, in the Portuguese acronym). The amending proposal provides the inclusion of activities and updates on quality control requirements. An AIR is also presented. More information is available here (in Portuguese).
Contributions to PC n. 911/2020 can be submitted through this digital form (in Portuguese) and those to PC n. 912/2020 through this digital form (in Portuguese). The new deadline is December 07.
