On-Market Rules and Authorities

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
On-Market Rules and Authorities
As discussed in Chapter , the Food and Drugs Act (FDA) and the Food and
Drug Regulations (FDRs) contain detailed rules regarding the issuance of
drug identication numbers (DINs) and notices of compliance (NOCs).
In addition to these rules, the FDA and FDRs contain requirements and
powers that apply when a drug is on the market. is chapter will discuss
some of these provisions, including those relating to:
powers relating to safety and eectiveness issues that pre-dated Vanessa’s
Law amendments, including adverse drug reaction reporting
rules regarding ()the marketing status of drugs and ()drug shortages
the range of new authorities introduced by Vanessa’s Law
the advertising of drugs
rules regarding the marketing status of a drug that has received a DIN
Before , Health Canada had a limited number of specic powers in the
FDRs enabling it to respond to safety and eectiveness concerns posed by
RSC , c F-.
CRC, c .
Protecting Canadians from Unsafe Drugs Act, SC , c  [Vanessa’s Law].

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