PACP Committee Report

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APPENDIX B : HEALTH CANADA RESPONSE TO A QUESTION ABOUT LICENSE APPLICATION PROCESSING TIMES

In response to a question at the hearing regarding time frames for processing a license application for natural health products, Health Canada provided the following information in a letter to the Committee:

All natural health products (NHPs) sold in Canada require a product licence in order to be sold and marketed in Canada. In addition, all manufacturers, packagers, labellers, and importers require a site license. The licensing requirements and timelines do not differ between domestically or foreign produced products

Timelines for product licensing:

Class	Definition	Timelines
Class I	Based on a single monograph	60 calendar days
Class II	Based on multiple monographs	90 calendar days
Class III	Outside of monograph process. Require a full assessment	210 calendar days

Timelines for site licensing:

Stream	Definition	Timelines
Stream I	Supported entirely by pre-cleared Good Manufacturing Practices (GMP) evidence (e.g., inspection by a recognized agency)	35 business days
Stream II	Supported by GMP evidence that is not pre- cleared, with up to 9 sites	65 business days
Stream III	Supported by GMP evidence that is not pre- cleared, with more than 9 sites	95 business days