Anvisa's Serialization Plan

*UPDATE*

In a SETRM event on 11/03/2021, Anvisa clarifies that the delivery date for the Serialization Plan is still to be made official. The platform will go through a testing period and its launch will be widely communicated. From this communication on, the deadline of 30 days to deliver the Serialization Plan will be valid, as per Normative Instruction IN 100/21.

ANVISA EXIGE ENTREGA DE UM PLANO DE SERIALIZAÇÃO

Normative Instruction No. 100/2021 (IN100) lays down the requirement to submit a serialization plan in relation to the implementation of traceability for prescribed drugs in Brazil. All registration holders must make the serialization plan available through the National Drug Control System (Sistema Nacional de Controle de Medicamentos, SNCM). If a registration holder has more than one manufacturing unit, the head office must complete a single plan and provide the information for all its units. Where applicable, outsourced or foreign plants must also be included in the same plan.

WHAT INFORMATION HAS TO BE ON THE SERIALIZATION PLAN?

In IN100, Anvisa requires that the plan must cover all production lines; be formally documented and approved by the Pharmaceutical Quality Management System and ratified by the company’s directors; be continually updated; contain information and data on the drugs, sites, production lines and stages involved; and provide implementation percentages until production lines are completely serialized. In the plan available on the SNCM platform, Anvisa asks for:

• Information about the plan (plan version, date it was set out, person responsible, etc.)
• General Details (number of plants, lines, distribution centers, etc.)
• Details of the plants and lines (name, whether outsourced, corporate tax ID (CNPJ), etc.)
• Details of distribution centers (name, type, CNPJ, etc.)
• Stages in the plan (mapping, approval, procurement, validation, integration, etc.)

To facilitate internal monitoring of what will be submitted to Anvisa, we have created an Excel document with the information to be submitted, so you can easily collect and distribute the information internally.

WHAT IS THE DEADLINE FOR SUBMITTING THE SERIALIZATION PLAN?

The serialization plan must be made available via the SNCM portal within thirty (30) days following the platform’s launch. 

WILL THE IMPLEMENTATION OF SERIALIZATION BE PHASED IN?

There will be no phasing in for the implementation of traceability in Brazil. IN No. 100/2021 reiterates the date of April 28, 2022 as the deadline in such a way that all registration holders must complete serialization by then and start notifying the registration of product activation and issuance events from April 28, 2022. 

You can get access to the system and to documents to guide registration holders in submitting and updating plans for implementing serialization and notifying