IS DRUG TRACEABILITY MANDATORY IN BRAZIL?

Drug traceability is not yet mandatory in Brazil, but regulations are in place that require pharmaceutical companies to deploy the technology for a group of drugs by April 2022. This will be done through a new platform that Anvisa has created, named the National Drug Control System (Sistema Nacional de Controle de Medicamentos, SNCM).

LAW ON TRACEABILITY

The law that makes drug traceability mandatory in Brazil is Law 13.140 of December 2016. In addition to this law on traceability, there is also RDC 319/19 and IN100/21, which make up the directives on the implementation of traceability.

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WHAT DRUGS HAVE TO BE INCLUDED IN THE NATIONAL DRUG CONTROL SYSTEM?

All drugs except those that are:

  • exempt from prescription;
  • specific, herbal and dynamized;
  • radiopharmaceuticals;
  • injectable contrast media;
  • medical gases;
  • parenteral solutions of 50ml and above;
  • serums, vaccines and drugs for government use; and
  • free samples.
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WHAT WILL BE THE NEXT STEPS ON THE WAY TO 2022?

According to IN 100/21, registration holders have to send a Serialization Plan to Anvisa. This is a simple document, but it has to ensure that the sector progresses in its implementation of traceability.

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WILL THE IMPLEMENTATION OF TRACEABILITY BE DIVIDED INTO STAGES?

Some countries have adopted regulations that divide the timescale for implementing traceability into serialization and aggregation stages. This is not the case in Brazil. Anvisa’s Questions and Answers says that IN 100/2021 reiterates the date of April 28, 2022 as the deadline for full SNCM implementation in such a way that all registration holders must complete serialization by that date and then start to notify the registration of product activation and issuance events. In spite of that, the market expects that Anvisa will show a degree of flexibility on the process as a whole.

HOW DO I START A DRUG TRACEABILITY PROJECT?

  1. Before doing anything else, it is important to bring together staff from the different departments that will be impacted by the traceability project
  2. Once your internal traceability team has been defined, establish which packaging lines will need to be equipped for serialization and aggregation.
  3. Next, you will need to gather together layout plans of the lines, showing the physical space constraints and other production information, so that a solution can be sketched out.
  4. Invite suppliers for a technical visit in order to sketch out a solution.
  5. This information will guide you in developing a User Requirement Specification (URS), which is an important step in determining what capabilities a solution needs to have in order to meet the company’s needs.

Steps in Implementing Traceability

WHAT CAN OPTEL OFFER THE PHARMACEUTICAL INDUSTRY?

Dedicated to pharmaceutical customers for over 30 years, OPTEL has become a global leader in traceability technology. OPTEL has the ideal solution for complying with the regulations or optimizing your supply chain. Watch a traceability solution in practice:

 

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