What Is Vanessas Law?
Resources –
- Guidance Document – Guidance on the Risk-Based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
- Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals – Guidance document
- MedEffect Canada
- Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) Amendments to the Food and Drugs Act (Bill C-17)
- Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals): SOR/2019-190
- Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals): SOR/2019-191
For additional information, please contact the Canada Vigilance Program at: Email: [email protected] Telephone: 1-866-234-2345
What does Vanessa’s Law stand for?
Resources –
- Guidance Document – Guidance on the Risk-Based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
- Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals – Guidance document
- MedEffect Canada
- Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) Amendments to the Food and Drugs Act (Bill C-17)
- Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals): SOR/2019-190
- Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals): SOR/2019-191
For additional information, please contact the Canada Vigilance Program at: Email: [email protected] Telephone: 1-866-234-2345
When did Vanessa’s law come into effect in Canada?
The corresponding legislation was introduced to protect Canadians from unsafe drugs, and received final Royal Assent in November 2014. As a result of Vanessa’s Law, health-care institutions are required to report on adverse drug reactions to Health Canada effective December 16
Who was Vanessa and what happened to her?
Who was Vanessa? –
- Vanessa Young died in 2000, at the age of 15, of a cardiac arrhythmia after taking cisapride (Prepulsid®) as prescribed.
- A campaign for increased regulation of therapeutic products subsequently led to greater powers for Health Canada to request safety data from hospitals and industry about drugs and medical devices.
- Vanessa’s Law was enacted in 2014 and the mandatory reporting requirements come into effect December 16th, 2019.
How did Vanessa Young die from cisapride?
Who was Vanessa? –
- Vanessa Young died in 2000, at the age of 15, of a cardiac arrhythmia after taking cisapride (Prepulsid®) as prescribed.
- A campaign for increased regulation of therapeutic products subsequently led to greater powers for Health Canada to request safety data from hospitals and industry about drugs and medical devices.
- Vanessa’s Law was enacted in 2014 and the mandatory reporting requirements come into effect December 16th, 2019.
What does Vanessa’s Law stand for?
Resources –
- Guidance Document – Guidance on the Risk-Based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
- Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals – Guidance document
- MedEffect Canada
- Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) Amendments to the Food and Drugs Act (Bill C-17)
- Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals): SOR/2019-190
- Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals): SOR/2019-191
For additional information, please contact the Canada Vigilance Program at: Email: [email protected] Telephone: 1-866-234-2345
Who was Vanessa and what happened to her?
Who was Vanessa? –
- Vanessa Young died in 2000, at the age of 15, of a cardiac arrhythmia after taking cisapride (Prepulsid®) as prescribed.
- A campaign for increased regulation of therapeutic products subsequently led to greater powers for Health Canada to request safety data from hospitals and industry about drugs and medical devices.
- Vanessa’s Law was enacted in 2014 and the mandatory reporting requirements come into effect December 16th, 2019.
How did Vanessa Young die from cisapride?
Who was Vanessa? –
- Vanessa Young died in 2000, at the age of 15, of a cardiac arrhythmia after taking cisapride (Prepulsid®) as prescribed.
- A campaign for increased regulation of therapeutic products subsequently led to greater powers for Health Canada to request safety data from hospitals and industry about drugs and medical devices.
- Vanessa’s Law was enacted in 2014 and the mandatory reporting requirements come into effect December 16th, 2019.