Brazil – Stop, Go

 

The proposed Brazilian regulation was halted last year and then reintroduced with changes in December 2016. The current proposals are out for review and discussion but can be broadly summarized as follows:

  • There will be a one year pilot project: Anvisa will select the participants and it is likely that 3 batches of products will be sampled or required
  • There will then be an analysis period of 8 months
  • Thereafter, it will be 3 years until full implementation

The proposals suggest the following key characteristics, although these may change as a result of the consultation period:

  1. 2D data matrix with the Anvisa registration number, serial number, lot number, expiry date
  2. Supply chain participants will report the required regulatory data to a central system operated by Anvisa

Get in touch with us

Europe

 +49 621 150204 0
 info [at] movilitas.com

North America

 +1 800 359 1712
 info.na [at] movilitas.com

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