Appendix 6 World Health Organization Causality Algorithm.Appendix 5 Other Adverse Reaction Reporting Programs Outside the Scope of this Document.Appendix 1 Glossary: Definitions and Terminology.4.2.3 Blinded Study Reports (in Phase IV).4.2.2.2 Non-Market Authorization Holder Sponsored Studies.4.2.2.1 Market Authorization Holder Sponsored Studies.4.2.1 Patient Support and Disease Management Programs.4.1.2 Reports Submitted to the Canada Vigilance Program by consumers or health professionals.3.7 Records to be Held for Auditing (C.01.020).3.5 Evaluation and Coding of Adverse Reaction Reports.3.2 Assessing Patient and Reporter Identifiability.3.1 Minimum Criteria for an Adverse Reaction Report.2.2.4 Unusual Failure in Efficacy (only applies to new drugs).2.2.1 Overdose, Medication Error or Occupational Exposure.2.2 Other Adverse Reaction Report Types.2.1.2.1 Canada's Access to Medicines Regime.2.1.1 Domestic Adverse Reaction Reports.2.1 Domestic and Foreign Adverse Reaction Reports.2 General Procedures for Expedited Adverse Reaction Reporting.1.6 Regulations Pertaining to Adverse Reaction Reporting.1.5 Unexpected Adverse Reaction Reports.1.2 Adverse Reaction Reporting by Market Authorization Holders.This document should be read in conjunction with relevant sections of other applicable guidance documents. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.Īs a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
#Aer meaning medical how to#
Guidance documents are meant to provide assistance on how to comply with governing statutes and regulations. Adverse Reaction and Medical Device Problem Reporting.
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