ANVISA – Traceability/Serialization

After ten years of extensive debate, since the enactment of Law 11.903 / 2009, on November 13th, RDC nº 319 was published, which deals with the implementation phase of the National Drug Control System (SNCM). Anvisa also opened a public consultation (CP 747), which establishes the deadlines for the commencement of data transmission and definitions for implementation of the SNCM with a deadline of 2 January 2020 for submission of contributions.

The traceability performed by SNCM is contained in the Brazilian’s law since 2009 and benefits the safety of patients and professionals with the monitoring of medicines throughout their production chain. It also helps manufacturers gain greater control over production and logistics by making it easier to maintain regulatory standards.

Count on Vita to assist your company in developing drug product registration and post-registration projects in Latin America.

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