[Table of Contents]

Volume: 26S1 - February 2000

Guidelines for Reporting Adverse Events Associated with Vaccine Products
Supplementary guidelines for the Canadian Pharmaceutical Industry

Appendix 4 - Important Addresses

The preferred method of reporting vaccine associated adverse events (VAAE) is by mail, although the Division has its own direct fax line. All VAAE reports and summary reports for marketed vaccines should be sent to:

Division of Immunization
Bureau of Infectious Diseases, LCDC
LCDC Bldg, Tunney's Pasture
Postal Locator: 0603E1
Ottawa, Ontario K1A 0L2
Telephone: 613-957-1340
Fax: 613-952-7948

VAAEs reported as per the IND Regulations should be clearly labelled as such and sent to:

Submission and Information Policy Division
Bureau of Drug Policy and Coordination, TPP 1620 Scott Street, Unit 14
Postal Locator Code, 3000E
Ottawa, Ontario K1A 0L2

Information on the WHO ADR Terminology Dictionary can be obtained from:

Sales and Public Relations Manager
The Uppsala Monitoring Centre
(WHO Collaborating Centre for International Drug Monitoring)
Stora Torget 3
S-753 20, Uppsala, Sweden

Final Report of CIOMS WorkingGroup I (Standardized ADR Report Form), CIOMS Working Group II (Guidelines for the Format for Periodic Safety Updates), and CIOMS Working Group III (Guidelines for Preparing Core Clinical-Safety Information on Drugs) can be obtained from:

CIOMS
c/o World Health Organization
Avenue Appia, 1211 Geneva 27, Switzerland

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