Food and Drug Regulations

C.01.014.4 If the information referred to in subsection C.01.014.1(2) in respect of a drug is no longer correct owing to a change in the subject matter of the information,

• (a) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(a) to (f)

  • (i) that occurs prior to the sale of the drug, a new application shall be made, or

  • (ii) that occurs after the sale of the drug, no further sale of the drug shall be made until a new application for a drug identification number in respect of that drug is made and a number is assigned; and

• (b) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(g) to (k)

  • (i) that occurs prior to the sale of the drug, the particulars of the change shall be submitted with the return of the document referred to in section C.01.014.3, or

  • (ii) that occurs after the sale of the drug, the person to whom the drug identification number in respect of that drug was issued shall, within 30 days of the change, inform the Director of the change.