Important Notice - Strategy for the Licensing of Natural Health Products (NHPs) with Drug Identification Numbers (DINs)

April 10, 2007

The purpose of the following notice is to clarify the product licensing application process (i.e. the process for obtaining a NPN) for those natural health products (NHPs) currently holding Drug Identification Numbers (DIN) issued prior to January 1, 2004. Specifically, this document clarifies that the application process for NHPs with DINs consists of a regular Product Licence Application without the safety and efficacy information required in section 5(g), as authorized under Sections 108 and 109 of the Natural Health Products Regulations.

As outlined in the transition provisions of the Natural Health Products Regulations, all NHPs with DINs must obtain a valid product licence and Natural Product Number (NPN) no later than December 31, 2009. Applicants are encouraged to apply as early as possible to transition their DINs to NPNs. This will provide the Natural Health Products Directorate (NHPD) with adequate time to review the application and will avoid any interruption in the sale of their products.

Section 109 of the Natural Health Products Regulations creates an exemption from the safety and efficacy requirements in Section 5(g) for products previously assessed and licensed by the Therapeutic Products Directorate (TPD) under the Food and Drug Regulations (i.e., natural health products previously granted market authorization pursuant to a DIN).

NHPs with DINs must receive a NPN by December 31, 2009. Companies may seek an NPN for their NHPs with DINs by submitting a Transitional DIN Product Application to the NHPD for assessment. The NHPD will review these transitional applications to ensure that the products comply with the Natural Health Products Regulations.

During assessment, the NHPD will focus on the elements required by the Natural Health Products Regulations once the exemption in Section 109 is applied to these applications. These elements include source material, non-medicinal ingredients (NMIs) and finished product specifications. Information on the label, where the Natural Health Products Regulations requirements differ from the requirements under the Food and Drug Regulations, will also be addressed to ensure compliance with the labelling requirements for NHPs.

Applicants will only be able to file a Transitional DIN Product Application if the product and associated claims are identical to what was approved by the TPD. Any changes to the product and/or associated claims will result in the removal of the submission from this process / refusal of the submission. Note the only exceptions: addition of risk information to the product (e.g. risk statements from NHPD monographs) and changes to non-medicinal ingredients.

Prior to the issuance of a Product Licence and NPN for NHPs with DINs, the NHPD requires all products to meet the requirements of the Natural Health Products Regulations. Applicants are encouraged to include new risk information from published NHPD monographs when filing a Transitional DIN Product Application. This additional information allows the consumer to make a more informed decision about a product.

Transitional DIN Product Applications must include all the information listed further below ( Transitional DIN Application Requirements). The NHPD will conduct a review of the application to ensure that all application requirements have been met. A Product Licence and NPN will be issued in which the recommended conditions of use (i.e. claims, dose, duration of use, dosage form, and risk information) are listed.

Should an applicant wish to submit amendments not previously approved by the TPD with their application, the application will be assessed in the applicable Non-Transitional DIN queue.

Transitional DIN Application Requirements

As of May 1, 2007, all Transitional DIN Product Applications received by the NHPD must include the information listed below or the application may be refused. For transitional applications currently in queue at the NHPD that do not meet the requirements listed below, the applicants will be contacted by the NHPD and given the opportunity to amend their applications accordingly.

1. Cover Letter including the following attestations:
   • the DIN is valid at the time of filing;
   • the product and label are in compliance with the terms of marketing authorization issued by the TPD under the Food & Drug Regulations;
   • the product and associated claims are identical to what was previously approved by the TPD; and
   • the NMIs are listed on the Natural Health Products Online Solution, otherwise the cover letter must note those not on the list;
     
     
2. Completed Product Licence Application Form and Templates;
   
   
3. Copy of the label most recently approved by the TPD;
   
   
4. Copy of the proposed product label text meeting the labelling requirements for NHPs (Chapter 3 of the Labelling Guidance Document).
   
   Note: if the only claim on the TPD label is "For therapeutic use only", applications for vitamin and mineral products must include the health claim(s) indicated on the applicable NHPD monograph(s) (see: Listing of Monographs). Risk statements from applicable NHPD monographs should be added to the label;
   
   
5. Copy of the finished product specifications including identity, purity and potency;
   
   Note: if it is unclear as to which tests are used to identify the medicinal ingredients in the finished product, the raw material specification for that medicinal ingredient should be included as well;
   
   
6. Completed animal tissue forms, if applicable.
   
   Note: Specified risk materials (SRMs) are prohibited, therefore, if any non-medicinal ingredients are SRMs they must be removed or replaced by a non-SRM source material. This must be done in order to be categorized as a Transitional DIN Product Application; and
   
   
7. Product registration information:
   • Copy of Drug Notification form or Notice of Compliance
   • Copy of product information printed from the TPD Drug Products Database (DPD).