PSYC 3430 Lecture Notes - Lecture 16: Rexall, Sunnybrook Health Sciences Centre, Electronic Health Record
13 Jan 2020
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Insufficient evidence to support safety, efficacy or quality claims: must meet requirements of food and drugs act. If not approved, sponsor can supply additional info, resubmit late with additional data: some drugs have priority review process- faster for life-threatening drugs like cancer, aids. After approval: once drug in market, regulation continues, distributor must report an new info received concerning side effects, notify. Hpfb about additional studies: hpfh conducts market surveillance, monitors adverse reactions reports, complains. Mandate & jurisdiction: patent medicine price review board (pmprb) is a body established by. Parliament in 1987 under patent act : pmprb protects the interests of canadian consumers by ensuring the prices of patented medicines soled in cnd aren"t excessive. It reviews prices that patentees charge for each drug. Section 4: drug information systems and personal health records. Drug information systems (dis: canada health infoway defines dis as: a tool that enables authorized health care providers to access, manage, share & safeguard patients" medication histories.
