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Guidance on Advance Notice of Importation under section 21.1 of the Medical Devices Regulations (MDR) and section 3.1 of the Radiation Emitting Devices Regulations (REDR) Download the alternative format (PDF format, 600 KB, 18 pages) Organization: Health Canada Published:…
ARCHIVED - Product Recall Procedures We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be updating it. You can use it for research or reference. (PDF Version - 97 K) (December 10, 1993)…
Inspection Strategy for Good Pharmacovigilance Practices (GVP) for Drugs (POL-0041) (PDF Version - 156 K) Notice Contact Information Our Mandate: To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human…
Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063) (PDF Version - 295 K) Notice Contact Information Our Mandate: To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs…
Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102) (PDF Version - 286 K) Notice Contact Information Our Mandate: To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human and veterinary);…
Notice to Stakeholders - New name for the Post-Market Reporting Compliance (PMRC) inspection program to Good Pharmacovigilance Practices (GVP) February 11, 2013 Good Pharmacovigilance Practices (GVP) is the new name for the Post-Market Reporting Compliance (PMRC) inspection…
ARCHIVED - Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004 We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be updating it. You can use it for research or…
ARCHIVED - Summary Report of the Inspections of Clinical Trials Conducted Under Voluntary Phase We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be updating it. You can use it for research or…
Summary Report of Inspections of Clinical Trials Conducted from April 2004 to March 2011 (PDF Version - 287 K) Contact Information Our Mandate: To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human…
Regulations amending the food and drug regulations (1024 - clinical trials) Contact: Good Clinical Practices Compliance Unit Tel : (613) 952-8173 Fax : (613) 952-9805 E-Mail : GCP_BPC@hc-sc.gc.ca (PDF Version - 103 K) Cover Letter 1600 Scott Street OTTAWA, Ontario K1A 1B6 June…
Early release: coverage is bounded to the current corpus, and features may change.
