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Reporting Adverse Reactions to Marketed Health Products : Guidance Document for Industry. Cover Image E-book E-book

Reporting Adverse Reactions to Marketed Health Products : Guidance Document for Industry

Summary: 'This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products'--Scope, p. 1.

Record details

  • ISBN: 9780660019628
  • Physical Description: remote
    1 online resource (43 pages).
  • Publisher: Ottawa, ON, CA: Health Canada, 2018.

Content descriptions

General Note:
Issued as part of the desLibris documents collection.
Restrictions on Access Note:
Access restricted to authorized users and institutions.
Type of Computer File or Data Note:
Electronic monograph in PDF format.
System Details Note:
Mode of access: World Wide Web.
Subject: Adverse drug reaction
Adverse effect
Biopharmaceutical
Causality
Clinical trial
Council for international organizations of medical sciences
Disease
Dose (biochemistry)
Health
Health care
Adverse event
Adverse reaction
Arts, culture and entertainment -- Arts and entertainment -- Literature
Biologics
Causality
Cioms
Clinical trial
Diagnosis
Economy, business and finance -- Economic sector -- Chemicals
Economy, business and finance -- Economic sector -- Chemicals -- Pharmaceutical
Health
Health -- Health treatment -- Medicine
Ich
Medicinal product
Pharmacovigilance
Science and technology
Science and technology -- Biomedical science
Science and technology -- Biomedical science -- Pharmacology
Science and technology -- Natural science -- Biology
Genre: Electronic books

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