Medicines

Draft Resolution 552, 3 September 2018 (8 page(s), in Portuguese)

This Draft Resolution 552/2018 establishes the content of the Periodic Report of Evaluation of Risk-Benefit provided by the medicine registration holder.

The Periodic Report of Evaluation of Risk-Benefit:

·         applies to all the registered medicines in national territory (Brazil);

·         is a technical document prepared by the medicine registration holder and must be presented to Anvisa on specific periods according to the active principal;

·         consists of the update of the national and international safety information and the analysis of the risk/benefit relation;

·         must provide information about indications, pharmaceutical formulation and posology by active principle;

·         shall be used by the holders to conduct systematical analysis in order to previously identify problems and propose interventions;

The product registration holder is responsible for the Report elaboration and submission to Anvisa. The medicine registration holder must have its own Reference Document on Medicine Security containing the consolidated information about medicine safety to provide a practical, efficient and consistent approach of the risk/benefit evaluation.

The compulsory utilization of the Medical Dictionary for Regulatory Activities (MedDRA) is established. The Reports submitted to Anvisa must follow the format and content established on the updated version of the E2C Guide of the International Conference on Harmonization (ICH).