On-Market Rules and Authorities

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 80-94

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SIX

On-Market Rules and Authorities

A. INTRODUCTION

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

• labelling

• rules regarding the marketing status of a drug that has received a DIN

B. PRE-VANESSA’S LAW POWERS

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].