On 20 April 2018 the sections of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) that grant the minister of health powers to require assessments, tests and studies and create appropriate regulations came into force.
The accompanying Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) came into force on 23 April 2018, with the exception of the provision relating to foreign risk reporting requirements, which will come into force on 23 October 2018.
Among other things, the amendments to the regulations:
- establish a framework to require assessments, tests and studies;(1)
- support post-market safety by imposing notification requirements for foreign incidents, which must be reported within 72 hours;(2) and
- eliminate the requirement for filing clinical case reports in a filed submission or supplement – unless requested by the minister of health – in order to alleviate the administrative burden.
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) See also consequent revisions to Health Canada's "Amendments to the Food and Drugs Act: Guide to New Authorities" (power to require and disclose information, power to order a label change and power to order a recall).
(2) See also "Draft Guidance Document for Notifying Health Canada of Foreign Risk" (final guidance expected soon).
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