Implementation of Brazilian Pharmaceutical Traceability – SNCM
Pharmaceutical traceability in Brazil started with the promulgation of law 11.903 in 2009, which defines the national pharmaceutical track and trace system, the short name: SNCM (Sistema Nacional de Controle de Medicamentos). The project underwent several changes in 2016 with law 13,410 by contributions of industry and projection of other country implementation practices. The Brazilian state aims to prevent counterfeit medicines and pharmaceutical trafficking that are very common in the market by implementing the SNCM project across the country.
The SNCM project gained momentum 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 wants the pharmaceutical industry to make the required preparations for pharmaceutical traceability in Brazil by April 2022.
The pharmaceutical traceability system defined by SNCM includes concepts that the pharmaceutical industry is not very familiar with, such as registration of drugs at every point in the supply chain, serialization, and aggregation of drugs. 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 is a global civil organization that defines several standards for the identification of products. By 1900s, when traceability practices were not very common, it was founded as an organization that sets standards in order to facilitate commercial activities with the barcode. For instance, the EAN-14 code on the foods which we buy from the grocery store is a standard created by GS1.
GS1 has expanded its range of application 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
Any product must have a distinctive feature to be tracked. 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 (IUM, Identificador Único de Medicamento). When this number is added in accordance with GS1 Standards, you can easily create 2D code for SNCM.
Checking the quality of the 2D code applied to the drug and rejecting (extracting from the line) the poor quality 2D code applied to the drug are 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
Aggregation is the name given to the method that allows drugs to be followed through the supply chain. 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. An efficient aggregation operation can be performed with systems that require more initial investment than square-coding. 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 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 points 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.
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 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 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’s software and hardware solutions for serialization and aggregation.