Important Notice - New Approach to Compendial Reviews

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June 24, 2008

The Natural Health Products Directorate (NHPD) has adopted a new approach to the review of compendial Product Licence Applications (PLAs). Effective June 24, 2008, Information Request Notices (IRNs) will no longer be issued for deficient compendial PLAs. The information provided in the PLA and proposed label text must correspond in full to that which is outlined in the monograph or the PLA will be refused. Applications corresponding in full to the monograph will proceed directly to licensing.

This new compendial review approach will apply only to compendial PLAs received after the effective date of June 24, 2008. Compendial PLAs received prior to June 24, 2008 will continue to be reviewed as per the previous review approach and IRNs will be issued if deficiencies are identified.

The adoption of this new approach will not impact the NHPD's ability to process Compendial PLAs within the 60-day timeframe mandated by Section 6 of the Natural Health Products Regulations. Rather, it will enable the NHPD to maintain (if not increase) its high performance standard for Compendial PLAs. Furthermore, looking ahead to the future, this new method will help accustom applicants with the way Compendial PLAs will be reviewed and licensed once the NHPD's Online Solution is implemented.

Prior to submitting a Compendial PLA to the NHPD, applicants are strongly encouraged to verify the quality and completeness of their PLAs against the Compendial Completeness Checklist, which is available online at www.healthcanada.gc.ca/nhp under the Product Licensing Forms and Templates section.