This Draft Resolution proposes the implantation of the National Medicine Control System (NMCS) and the mechanisms and procedures for medicine track and tracing, besides other measures.

These mechanisms and procedures for medicine track and tracing is applicable throughout the national territory. 

The provisions of this proposal apply to all medicines registered at the Brazilian Health Regulatory Agency (ANVISA) . It is not applicable to serum and vaccines that are part of the National Immunization Program; radiopharmaceuticals; non-prescription medicaments; medicines included on the Programs of medicines for free distribution and individualized delivery control of the Ministry of Health; specific medicines and phytomedicines; free samples.

Medicine track and tracing system establishes mechanisms and procedures that allow to recovery the medicine history, identify its current location and the last known destination.

The bidimensional bar code is the technology used to capture, store and comunicate events related to medicine track and tracing on the NMCS and the DATAMIX is the adopted standard as established on ISO/IEC 16022:2006. The owner of the medicine marketing authorization is responsible for the generation and inclusion of the Datamix on the comercial package, including data of the Unique Medicine Identificiation (UMI) and other provisions established at RDC Nº 71 from 22 December 2009 (available at http://bvsms.saude.gov.br/bvs/...) and modified by the RDC Nº 26 from 16 June 2011 (available at http://bvsms.saude.gov.br/bvs/...) .

Every transport package, from expedition at the marketing authorization owner, should have a unique identification code that allows identify the UMI inside it.

Imported medicines may have the Datamix and serial code printed by the manufacture on the country of origin or by the owner of the authorization in Brazil. The option adopted should be informed to Anvisa at the process for the Import Licence.

Each member at the medicine supply chain should store and transmit electronically the data regarding the events of the medicine under its responsibility.

The technological specifications related to the NMCS procedures will be published as Normative Instruction before the end of the fourth month after the date of publishing of this technical regulation.

This proposal revokes the Resolution RDC Nº 54 from 10 December 2013 (available at http://bvsms.saude.gov.br/bvs/...) and the RDC Nº 114 from 29 September 2016 (available at http://portal.anvisa.gov.br/do...)