As of January 1st, 2004, a Drug Identification Number (DIN) will no longer be issued for natural health products (NHPs) under the Food and Drug Regulations. Instead, market authorization for a natural health product may be obtained by sending a Product License submission package to the Natural Health Products Directorate to be approved under the Natural Health Products Regulations. The NHP Regulations and information needed to prepare a separate and complete Product Licence submission will be available mid- November on the NHPD web site: www.healthcanada.ca/nhpd, or can be ordered directly by calling 1-888-774-5555.
Products Currently or Soon to be in the Queue:
Applicants with a DIN submission being processed, can apply to have the submission transferred to the Natural Health Products Directorate (NHPD) prior to January 1st, 2004. A consent form is required which must be submitted to NHPD before December 1, 2004 and placed in a pririty queue. Applicants not transferring the submission will not be placed in the NHPD priority queue.
Applicants seeking a DIN should note the 45-225 day performance targets as TPD will not guarantee that a DIN will be issued prior to December 31st, 2003., and cannot issue DIN's after this date.
After December 31st, TPD and NHPD intend to jointly contact NHP applicants who have not yet been issued DIN's, and these applicants must then submit a separate and complete Product Licence submission to the NHPD, at which time it will be placed in queue.
More information is available at:
Additional queries may be directed to:
Health Products & Food Branch
Natural Health Products Directorate
Submission Management Division
2936 Baseline Road, 2nd Floor
Address Locator 3302B
Ottawa, ON K1A 0K9