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SNCM – The Brazilian Pharmaceutical Control System
Pharmaceutical traceability in Brazil started with the SNCM’s announcement of law 11.903 in 2009, which defines the national pharmaceutical track and trace system. The project has done several changes with law 13.410 in 2016. The Brazilian Health Regulatory Agency (ANVISA) aims to prevent counterfeit medicines and pharmaceutical trafficking that are very common in the market by implementing the SNCM across the country.
The SNCM strengthened after the successful completion and the publication of its report in 2019 of the pilot project under the control of ANVISA, the SNCM project implementer in Brazil. ANVISA wanted the pharmaceutical industry to make the required preparations for pharmaceutical traceability in Brazil by April 2022.
The pharmaceutical traceability system implemented by SNCM includes concepts that the pharmaceutical industry is not very familiar with, such as registration of drugs at every stop in the supply chain, serialization, and aggregation of pharmaceuticals. This article was prepared by VISIOTT experts to help you accurately and easily integrate your business into the processes of the pharmaceutical traceability project, which will be implemented in Brazil in April 2022. Experts will respond as soon as possible if you leave a question or comment in the section at the bottom of the page.
Basic Concepts of SNCM
The primary function of SNCM is collecting data in the supply chain in a central database and ensuring this data can be queried by authorized stakeholders (drug manufacturer, warehouse, pharmacy, hospital, etc.). To fulfill this function, SNCM defines new concepts for the industry in many operations, from manufacturing to supply chain. We try to explain these concepts below to clarify SNCM.
GS1 Standards and Registration Procedures
GS1 has expanded its range of applications in recent years and has done standard studies on traceability and published these standards so that all industries can use them. Only GS1 Datamatrix is used in ANVISA’S SNCM project from these standards. You can click on this link for details of the standard. You can also get your GTIN (Global Trade Item Number) and GLN (Global Location Number) information from the GS1 office in Brazil, which is managed by the GS1 organization.
Serialization Application with SNCM
Serialization is the name given to the operation of applying 2D code (GS1 Datamatrix) containing different information to each carton. The application can be done by direct writing or scraping on the carton. The method of affixing a 2D code-printed label onto the carton is also often used for imported drugs.
The 2D code of the GS1 Datamatrix type used in the SNCM project contains a singular ANVISA registration number beginning with the number 713, unlike serialization applications in the world. When this number is added in accordance with GS1 Standards, 2D code can easily be created for SNCM.
Verifying the quality of the 2D code applied to the drug and rejecting (taking out it from the line) the poor quality 2D code applied to the pharmaceutical is part of the serialization process. Serialization can be integrated into the drug packaging line as well as done manually. More detailed information about this topic can be found on the link.
Aggregation Application with SNCM
After the drugs are manufactured or ready for sale, a barcode label is affixed to the transport units (bundle, case, pallet, etc.) pointing to the data of the Data Matrix. When the barcode on this label is read, the data of all the DataMatrix in the transport unit must be accessible. The hierarchical data obtained as a result of aggregation is transferred to ANVISA’s system. Stakeholders can use data on this system to accept and sell drugs without slowing down the supply chain.
More detailed information about this topic can be found on the link.
The Design of Processes in The Supply Chain
As we mentioned earlier, SNCM aims to record the entire life-cycle of the drug. Once a drug has been manufactured or imported, it passes through two or three stops until it reaches the pharmacy. These points are usually pharmaceutical warehouses and value-added logistics providers. In the pharmaceutical traceability systems defined as SNCM, at all these points, the drugs are first accepted and taken ownership, then transferred to another point by return or sale process.
In order to achieve traceability in the supply chain, the processes listed below need to be redesigned.
- Production
- Release
- Storage
- Picking
- Shipping
- Return
- Destruction
Transmission of Traceability Data to ANVISA
At the end of each process defined by the SNCM, data emerges. Data consisting of a predefined XML format is used to track the drug in the supply chain. In order to ensure tracking, the resulting data must be transferred to ANVISA’s servers via the internet. You must have a valid digital certificate to access SNCM servers. All data is transferred to servers using web services via the secure SOAP interface. The significant notifications found in the SNCM system are named as:
- Activation (Ativação)
- Expedition (Expedição)
- Receivement (Recebimento)
- Completion (Finalização)
- Replacement (Substituição)
- Revocation (Revogação)
You can reach more detailed information from the SNCM document.
Integration with Third-Party Software
Data integrations with third-party software may be necessary to establish accurate traceability in the supply chain. These integrations may be third-party traceability software, or ERP, WMS, or MAS software that does not have traceability fiction. Integrations often become a requirement when traceability projects are completed and processes are understood by administrators. Testing and validation of these integrations, which usually require customer-specific software development, must be done. Otherwise, these integrations may cause irreversible errors in your traceability process.
VISIOTT TPS has been providing solutions to the pharmaceutical industry on pharmaceutical traceability since 2008. It has designed, developed and engaged the solutions it offers according to the requirements of the industry. Please click here to review VISIOTT TPS software and hardware solutions for serialization and aggregation.
VISIOTT TPS also has a website in Portuguese in which specific solutions are shown for the Brazilian market. So as to review our traceability solutions for Brazil click here.
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Concise and to the point !
Thanks for this informative article. Simple, clear but also a detailed expression.
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Keep up the Good Work!!
Thanks for a good article. Rumors says that implementation date of 28. April 2022 might be postponed. Is this something you can confirm or reject? Thanks.
Thank you for this great article! Is Aggregation mandatory or optional for manufacturers?
The Board of Directors (DICOL) of ANVISA approved during its meeting of 20th August the Normative Instructions establishing the SNCM.
The deadline for implementation remains 28 April 2022.
https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/acompanhe-a-16a-reuniao-da-diretoria-colegiada-da-anvisa
https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/rastreabilidade