Notice - Revised Implementation Procedures for Product Monograph Guidance

Date: 2006-05-29


May 29, 2006

Revised Implementation Procedures for Product Monograph Guidance

Our file number: 06-111777-525

The Health Products and Food Branch (HPFB) implemented revised Product Monograph (PM) requirements, in accordance with the Guidance for Industry: Product Monograph, on October 1, 2004. Experience with the new PM format has since prompted HPFB to revise its approach to implementation.

Interim modifications to the application of the Guidance, in specific situations, is being introduced. These interim modifications do not apply in cases where the PM has already been submitted to HPFB in the new format i.e., a PM submitted in the new format cannot be replaced with one in the previous format.

Effective immediately, the requirement to file under the new PM format will apply to the following submission types only:

  • New Drug Submissions (NDS), and
  • Abbreviated NDSs (ANDSs)and Supplemental ANDSs (SANDSs), where the innovator PM is in the new format.

As part of these interim modifications, it will not be a requirement to file under the new PM format for Supplemental NDSs (SNDSs) and Notifiable Changes (NCs). However, HPFB recognizes the significant progress that has been made by sponsors to date in implementing the new Guidance for these other submission types and strongly encourages sponsors to continue submitting PMs in the new format where possible. To facilitate the filing of PMs in the new format for NCs and SNDSs, HPFB will exercise flexibility, in particular as it relates to:

  • Clinical Trial data (for drugs deemed to be older), and
  • Adverse Drug Reactions (incidence reporting thresholds for drugs deemed to be toxic and for drugs for smaller populations).

Filing with the revised format for other submission types, including ANDSs, where the innovator PM is in the old format, while encouraged, will be on a voluntary basis at the sponsors' discretion.

The Branch is reviewing feedback received to date in order to develop a revised implementation proposal that addresses other scenarios as appropriate. Opportunities to provide additional input into the proposal will take place in the summer months.

Comments or questions regarding this Notice or consultations should be directed to

Bureau of Policy, Science and International Programs,
Therapeutic Products Directorate,
1600 Scott Street,
Holland Cross, Tower 'B',
2nd Floor, A.L. 3102C5,
Ottawa, ON
K1A 1B6.

Fax: (613) 941-6458

E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca

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