With legislation dating back to January 2009, requirements for serialization and reporting in Brazil has been underway for a long time now. Those of us having worked with serialization for a while, may remember working feverishly in second half of 2015 to comply with an almost impossibly complex set of requirements. The goal at the time was to demonstrate full compliance for 3 batches including track and trace throughout supply chain as was mandated by the RDC 54/2013. Although the requirements seemed unrealistically ambitious and rumors were circulating that the legislation would be suspended, nothing was firm enough to comfortably ignore the requirements. Official suspension of the 3 batch pilot in October 2015 was a great relief and with the remaining parts of the resolution being suspended in September 2016 the scene was set for a fresh start for implementation of serialization in Brazil.
Since then, the industry has matured significantly and so has the legislation. So although a few pieces of the puzzle is still missing, we believe that the time is now ripe to start preparing for serialization in Brazil.
The information in this post represents the high level information we have gathered from currently available documents and presentations from Anvisa. Some details are still uncertain and we would be grateful for any feedback if you have insights that could aid in consolidation of the information. References and definitions are provided in the end of the post.
In its essence, the requirements cover
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- Serialization of secondary packaging
- Aggregation to shipperbox level
- Reporting of commissioning, aggregation, supply chain events (shipping and receiving) and destruction to a central repository.
Packaging
Commercial packaging must be marked with:
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- Global Trade Item Number – GTIN-14 (Specified in RDC 157 Art. 6)
- ANVISA registration number
- Serial number
- Expiry date
- Batch number
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Collectively, the above is called the UIM – the Unique Medication Identifier. It is explicitly stated that the above order of information must be respected.
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.
A GS1 DataMatrix must be added to the package and, although not explicitly stated, it is expected that the DataMatrix must encode the entire UIM.
The use of the term “sealed commercial packaging” in RDC 319 further hints that there may be a requirement for tamper evident packaging, but we have not found further information supporting this.
Aggregation to shipperbox level is mandated in RDC 157 Art. 7.
Scope
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:
I. Over-the-counter drugs
II. Specific drugs, herbal and dynamized
III. Radiopharmaceuticals
IV. Injectable contrast media
V. Medical gases
VI. Large Volume Parenteral Solutions
VII. Serums and vaccines that are part of the National Immunization Program
VIII. Drugs belonging to the Ministry of Health’s Programs, for free distribution and individualized delivery control and
IX. Free samples
Reporting
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.
Timeline
In the law, the timeline is explained relative to completion of three stages:
I. up to one year, so that the industry, the importers and the distribution and retail representatives chosen by the competent federal health surveillance agency can, on an experimental basis, receive and transmit data referring to at least three batches of medicines that contain the information provided for in items I, II, III and IV of § 1 of art. 3rd;
II. up to eight months after the end of the stage established in item I of this paragraph so that the results obtained during the experimental phase are subject to analysis, correction and validation report by the competent federal health surveillance agency, through the Management Committee;
III. up to three years after the end of the stage established in item II of this paragraph, for the complete implementation of the National Medicines Control System.
The above definitions are not very operational from a planning perspective. What we can understand from Anvisa is that a planned set of deadlines are as follows:
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- 01/08/2020 – Anvisa plans to go live with the SNCM reporting system
- 01/12/2020 – Soft deadline for implementation. Lack of compliance must be mandated by Anvisa on the basis of an implementation plan to be uploaded to SNCM. The plan must include start and end date of the project, and include at least the following steps: process mapping, approval of the acquisition plan by the management, equipment acquisition and installation, validation and updating of the quality management, concluding with the integration with the logistic processes and reporting to SNCM. The last three need to be per production lline.
- 28/02/2022 – Deadline to those who have presented an implementation plan
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Glossary
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 :
Law: 2009-11-903, modified in Law: 2016-13-410
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