Draft Guidance Document - Tamper-Resistant Formulations of Opioid Drug Product Submissions

Consultation on the Draft Guidance Document: Tamper-resistant Formulations of Opioid Drug Product Submissions

Opioid drugs are subject to the Food and Drugs Act. An opioid drug may be sold in Canada following a decision by Health Canada that the scientific evidence submitted by its manufacturer meets established standards for safety, efficacy and quality for the drug under the recommended conditions of use….


http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_guid_opioid_ebauche_ld-eng.php