How to be Ready for Serialization Regulation in Brazil
- Carlos Colon-Rivera
- Jun 3, 2021
- 4 min read
Brazil’s legislation has had a complex set of requirements for putting into effect their serialization and reporting processes in order to achieve complete compliance. Back in 2016, ANVISA signed the National Medicine Control System SNCM into law (Law No. 13.410). It establishes the timelines and serialization requirements for the complete Brazil pharmaceutical supply chain. The legislation in Brazil has had a set of complex requirements for put into effect their serialization and reporting processes in order to achieve full compliance.
After the pilot phase in 2017-2018, the Brazilian industry has grown and matured which has also impacted the legislation. This is the reason to start preparing for serialization in Brazil as soon as possible. The Brazilian Health Regulatory Agency, well known in Portuguese as (Agência Nacional de Vigilância Sanitária, ANVISA) is planning on implementing a thorough nationwide serialization solution and it’s regulations are planned to go into effect in May 2022. The set regulations of the SNCM, must be followed by all pharma companies that are manufacturing or importing goods to Brazil.
With additional upcoming deadlines in 2021 and 2022, during and after the COVID-19 pandemic, it’s recommended to start preparing as earlier as possible to ensure you are in full compliance with the Brazil serialization law.
ANVISA set upcoming deadlines for 2021 & 2022
ANVISA set upcoming deadlines for 2021 & 2022 as follow:
Deadline for 2021
April 2021 – Serialize 50% of the products Pharmaceutical companies have to serialize 50% of their products
September 2021 – Serialize 75% products By this month, Pharmaceutical companies have to serialize 75% of their products
Deadline for 2022
April 2022 – Serialize 100% of the products Pharmaceutical companies have to serialize a 100% of their products
The timelines as per the law**, requires a three stage completion:
Up to (1) one year. The competent federal health surveillance agency chosen industry, importers and distribution and retail representatives can, on a trial basis, receive and transmit data referring to a minimum of three batches of drugs that contain the information provided for in items I, II, III and IV of § 1 of art. 3rd.
Up to (8) eight months after the end of the stage 1 mentioned in the above. The results from the trial phase will need to undergo analysis, validation report and correction by the competent federal health surveillance agency, via the Management Committee.
Up to (3) three years after the end of the stage 2 mentioned in above. This is for the complete implementation of the National Medicines Control System.
The requirements for Brazil’s serialization can be summarized with these three key areas:
Serialization of the Secondary packaging level.
Aggregation down to the shipper box level. This is a mandate in ANVISA’s RDC 157 Art. 7.
Reporting of shipping and receiving supply chain products, aggregation, repository and any destruction (decommissioning) caused as well as commissioning of goods.
Serialization Packaging All commercial packaging must have clear markings and it is compulsory to include the following UIM – the Unique Medication Identifier markings:
A unique Global Trade Item Number – GTIN-14 (Specified in ANVISA’s RDC 157 Art. 6).
The ANVISA registration number
Serial numbers for the products. The serial number must be unique per GTIN with no serial number reuse policy detailed. As per GS1 specifications, the SN may be up to 20 characters alphanumeric and must be randomized.
Expiry dates of the goods
All batch numbers
It’s not mandated as of yet, but it’s a good practice to add GS1 DataMatrix to the packages and have them encoded with the entire UIM.
Scope of Law Law 13,410 specifies that the scope of the law is medicinal products for human, veterinary, as well as the other types of movement provided by sanitary controls. In a yet to be released normative instruction, it is further specified that serialization reporting is optional for drugs belonging to the following categories:
Over-the-counter drugs
Specific drugs, herbal and dynamized
Radiopharmaceuticals
Injectable contrast media
Medical gases
Large Volume Parenteral Solutions
Serums and vaccines that are part of the National Immunization Program
Drugs belonging to the Ministry of Health’s Programs, for free distribution and individualized delivery control
Free samples
Reporting Requirements With regards to reporting, the requirements seem to be a somewhat simplified version of the requirements for reporting to the Russian MDLP system. Reporting to a centralized repository is required for commissioning, aggregation, supply chain events (shipping and receiving) and destruction. This sounds like a lot, but from an MAH only doing export to Brazil, this translates to reporting of commissioning, aggregation and shipping. As for upload options, we have understood that there will be an option to report EPCIS XML files using webservices or manually uploading a CSV file via a web interface.
The reporting is required to be done in chronological order and, for an MAH, within 3 business days after occurrence of the event being reported.
In this context, one should be aware that there may be reasons to establish reporting “horizontally” among supply chain partners in addition to reporting to the central SNCM repository.
Glossary of terms
ANVISA: Brazilian Health Regulatory Agency (in Portuguese, Agência Nacional de Vigilância Sanitária)
RDC: Resolution of the Board of Directors, ANVISA (in Portuguese, Resolução da Diretoria Colegiada)
SNCM: National Medicine Control System (in Portuguese, Sistema Nacional de Controle de Medicamentos)
References See Anvisa’s web-page for latest information. The page is in Portuguese, so it is useful to have a translator such as Google Translate tool handy when exploring the site. http://portal.anvisa.gov.br/rastreabilidade
Specifically, the documents below provide useful information :
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