Title: Brazil 11.903 Track and Trace Mandate
Tags: REGULATORY UPDATE, SOUTH AMERICA, BRAZIL
On January 14 2009, in an effort to curb the growing counterfeit market, Brazil passed a law (Number 11.903) mandating the drug manufacturers and distributors to act on the specific serialization and track and trace requirements of electronic identification and data capture. This three year plan is by far the most aggressive deadline laid out by the Brazilian government.
Below is the year by year analysis and deadlines for each component type that the Brazilian government wishes to see serialized by the 2012 deadline. The most pertinent of these is the January 14, 2010 deadline that deals with the manufacturers and suppliers of pharmaceutical drugs.
January 14, 2010 Requirements
- Manufacturers (working authorization, state license and city sanitary authorization of the manufacturing establishments)
- Suppliers (wholesalers, retailers, exporters and importers of medications)
January 14, 2011 Requirements
- Purchasers (including establishments requiring products not expedited in prescriptions with several products)
- Products (product expedited or distributed and its amount)
- Transportation/logistic units
January 14, 2012 Requirements
- Prescription (including products not expedited in a prescription with several products)
- Doctor, odontologist and veterinary (registration at the board of the prescribing professionals)
Does anyone have updated information based on the delay of the implementation, new dates etc?
— Comment Posted 12/07/10 6:24pm EST by Anonymous