Pharma (Brasilien) – derzeit in der Warteschleife

Highlights of the reporting deadlines to ANVISA (SNCM):

Up to October 2021: 5% of the released batches in the Brazilian market should be serialised and reported.

November 2021–April 2022: 10% of the released batches in the Brazilian market should be serialised and reported.

1) Local Manufacturing

Manufacturers should have the following minimum percentages of packaging lines serialised and events reported as follows:

I—30% as of April 2022

II—70% as of April 2023 and

III—100% as of April 2024

2) Imports

Importing companies must have the following minimum percentages of batches marketed as serialised and reported:

I—30% as of April 2022

II—70% as of April 2023 and

III—100% as of April 2024

3) Distributors, Wholesalers, and Dispensers

April 2024: Distributors and wholesalers must report all events related to serialised drugs traded from April 2024 onwards.

III – 100% as of April 2024

Brazil Track&Ttrace regulations for vertical reporting for pharmaceuticals

A pharmaceutical product that is distributed in Brazil for human consumption is registered with ANVISA.

An ANVISA-registered product is serialised at the manufacturing location within or outside Brazil by applying a 2D Data Matrix on the saleable unit pack with the following info: GTIN, ANVISA registration number, Unique random serial number, Lot Number, and Expiry Date. Each pack is further aggregated to cases and pallets, which are uniquely identified with SSCC coding.

An 'Activation' message is sent by MAH holders to SNCM after commissioning and aggregation.

The product is shipped to a 3PL. The MAH holder sends the 'Dispatch' message to SNCM as soon as the shipping is performed.

The 3PL (receiver) receives the goods shipped from a MAH holder and sends the 'Receiving' message to SNCM after the goods are physically received at the warehouse.

The 3PL further ships the product to the distributor and sends a 'Despatch' message to SNCM at the time of shipping.

The distributor receives the goods shipped from 3PL and sends the 'Receiving' message to SNCM after the goods are physically received at the location.

The distributor further ships the product to dispensers, such as hospitals, and sends a 'Despatch' message to SNCM at the time of shipping.

The dispenser receives the goods shipped from the distributor and sends the 'Receiving' message to SNCM after the goods are physically received at the location.

The dispenser consumes the product by administering the medicine to patients and sending the 'Finalisation' message to SNCM. In addition to dispensers, MAH and other supply chain partners can also send a 'Finalisation' message to SNCM depending on the reasons as recommended by ANVISA.

Brazil Track&Trace regulations for horizontal reporting for pharmaceuticals

Horizontal reporting covers reporting of various events, like aggregation, shipping, receiving, returns, scrapping, decommissioning, etc., between the supply chain actors. It ensures the traceability data is consistent across the supply chain partners. Events/data exchange between partners is not required to be reported to SNCM but only among themselves. One manufacturer may ship products to more than one 3PL or directly to several distributors or dispensers. There can be too many points of origin and destinations, considering all possible combinations of drug distribution networks. This makes it a stupendous task to develop point-to-point connections among various supply chain partners. The challenge in horizontal reporting is to build a network of systems of all supply chain partners to enable the reporting of various events as and when they occur.

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