Eng De Esp Ru Pt

Pharma (Brazil)

Highlights of the reporting deadlines to ANVISA (SNCM):

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

Nov 2021-Apr 2022: 10% of the released batches in the Brazilian market should be serialized and reported.

 

1) Local Manufacturing

Manufacturers should have the following minimum percentages of packaging lines serialized 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 serialized 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 serialized drugs traded from April 2024 onwards

Brazil T&T regulations for pharmaceutical - vertical reporting

1

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

2

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

3

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

4

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

5

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.

6

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

7

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

8

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

9

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

10

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

Brazil T&T regulations for pharmaceutical - horizontal reporting

Horizontal reporting covers the reporting of the 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 product to more than one 3PLs or directly to several distributors or dispensers. These points of origin & destinations can be too many considering all combinations of drug distribution networks. This makes it a stupendous task to develop point to point connection among various supply chain partners.

The challenge in horizontal reporting is to build a network of systems of all supply chain partners to be enabled to report various events as and when they occur.