dicentra Special Alert: Proposal to amend the Food and Drug Regulations – Project 1663 – Schedule F Amendment

February 23, 2012 By
FOR IMMEDIATE RELEASEProposal to amend the Food and Drug Regulations -(addition of pancrelipase, pancreatin and pancreatic enzymes) – Project 1663 – Schedule F Amendment

In November 2011, the NHPD (rather subtly) revised the NHPID entries for pancrelipase, pancreatin and pancreatic enzymes to indicate that they are considering adding these ingredients to Schedule F. As such, they would no longer qualify as NHPs and could only be sold by prescription. A week ago, Health Canada formally posted a Notice of Intent regarding these enzymes and is inviting stakeholder feedback. This notice, as well as instructions for providing feedback, is available at http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1663-eng.php. Dicentra strongly encourages all product licence applicants who have pancrelipase, pancreatin and/or pancreatic enzymes in their products to read this Notice of Intent and to respond to Health Canada with their comments. The consultation deadline is April 30, 2012.
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