General TPD/HPFB, Post-Marketing, and Adverse Reaction Reporting:

 

TPD News (March / April 2004)

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/tpd_news_mar-apr_2004_e.pdf

 

Subject: Issue Analysis Summary: Look-alike Sound-alike (LA/SA) Health Product Names: The Development of a Comprehensive Policy Recommendation

http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/lookalike_soundalike_ias_e.pdf

 

Executive Summary: Look-Alike Sound-Alike (LA/SA) Health Product Names Consultative Workshop

http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/summary_consultation_workshop_e.pdf

 

Subject: Regulatory Requirements Governing Investigations Schedule C Drugs (Radiopharmaceuticals, Kits and Generators)

http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/cta_scheduleCdrug_e.pdf

 

Bill C-56 an Act Respecting Assisted Human Reproduction

http://www.parl.gc.ca/37/1/parlbus/chambus/house/bills/government/C-56/C-56_1/C-56TOCE.html

 

Marketed Health Products Directorate - NEW ADDRESS

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/mhpd_new_address_e.pdf

 

Pharmacovigilance Planning (PVP) E2E

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e2e_step2_e.pdf

 

Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e2dstep2guidance_e.pdf

 

Canadian Adverse Drug Reaction Information System (CADRIS)

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/fact_cadris_e.pdf

 

Adverse Reaction Reporting Guidance Document

http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/adverse_reaction_reporting_e.pdf

 

 

Last updated:  07/19/2004

Web Curator -Deborah Dragoon