Monday, April 20, 2015

Pharma Serialization Update - April

Bill Fletcher highlights a few key deadlines looming for Pharma Serialization:
  1. The FDA enforcement discretion not to enforce the transaction document aspects of the Drug Supply Chain Security Act (DSCSA) ends May 1. Companies who may have chosen to spend more time working out kinks in their transaction document (TD) may be running out of time.  
  2. There is controversy with the way shipper cases are tracked in Brazil.
  3. Companies selling into Brazil will now need to collect traceability data from 3 LOTs by December of this year. 
  4. Chinese traceability is fully effective this December.  
  5. New requirements in India for primary packages are creating very onerous designs on manufacturers
  6. EU delegated acts for Falsified Medicines is expected in the next couple of months. Encoding will include GTIN, country reimbursement code, LOT expiration date and serial number in human readable and encoded in a GS1 DataMatrix symbol
Bill Fletcher - Pharma-Logic