ANVISA RELEASES NEW REGULATION ON THE NATIONAL MEDICINES CONTROL SYSTEM
On February 17th, the National Health Surveillance Agency (“ANVISA”) released the Public Consultation No 311/2017 on the implementation of the National Medicines Control System (“SNCM”), proposing mechanisms and procedures for the traceability of medicines. With this Public Consultation ANVISA submits to the regulated sector a proposal of Resolution to substitute Resolution RDC No 54/2013 which is currently in effect.
The SNCM was created by Law No 11,903/2009 and aims to assure the traceability of medicines as a means to fight the counterfeit and theft of medicines, as well as to bring more effectiveness to recall processes.
Due to the great difficulties and resistances faced during its regulatory process, on last September, ANVISA decided to indefinitely suspend the implementation of the SNCM. However, as a result of Law No 13,410/2016, enacted on December 28, 2016, ANVISA received a four-months term to regulate the SNCM and a three-years term to fully implement it, which led to the release of the Public Consultation.
Among other aspects, the proposed Resolution provides for the obligation of the marketing authorization holder to identify every medicine unit with an individual number and a two-dimensional barcode (DataMatrix). Additionally, according to the proposed text, all members of the supply chain will be required to feed a central databank with information regarding all operations related to every medicine unit.
Contributions can be sent to ANVISA until March 17, 2017, through an electronic form available at the following website: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=30286
The Life Sciences Department of Kestener, Granja & Vieira Advogados is available to provide any further information required on this subject.
This article is intended exclusively to provide information and does not contain any opinion, recommendation or legal advice from KGV Advogados in relation to the matters herein addressed. Copyrights are reserved to Kestener, Granja & Vieira Advogados.
