NNHPD Regulatory Updates: Name Change, Three Class System Finalized and Pilot Program for Monograph Attestation for OTC

September 8, 2014 By

NNHPD released many updates recently including: changing the name of the Directorate, finalizing the 3 Class review system for NHPs, announcing a 6 month pilot program for NHPs that fall between Class 2 and 3 to provide expedited review times, and a 6 month pilot program for non-prescription drugs attesting to certain monographs.

In July of this year, the NHPD announced that it has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD), based on the expansion in the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). As such, the NHPD will herein be referred to as the NNHPD.

In addition to updating the name of the Directorate, the NNHPD has published the Final version of the Guidance document for the Management of Product License Applications for NHPs (June 30th, 2014). The guidance document signifies the finalization of the new three-class review system for application types and consequent timelines associated with an application type, which has been described in a press release earlier this year by dicentra (Link: http://dicentra.com/health-canada/nhpd-introduces-three-class-system-monograph-attestation-expedite-npn-registration). In addition to this update, another important highlight of this guidance document is found in the Classification of Amendments, as summarized in Section 6.1, Table 1 of the document. In this table, the NNHPD indicates that an amendment can be filed for numerous changes that were not previously acceptable in the NHPD’s post-licensing guidance document up to and including the addition/substitution or removal of a medicinal ingredient (all of which must be supported by a NNHPD Monograph). Prior to this guidance document, an addition/ removal/ substitution of a medicinal ingredient (regardless of its monograph status) was considered to be a fundamental change to a license, and applicants were required to submit new Product License Applications (PLAs) in order to make such changes. Timelines for amendments will vary depending on the type of change being made and the application class. A few examples are provided below:

1) Adding/removing/substituting a Pre-cleared Information (PCI) ingredient to a Class 1 product: 30 day review
2) Adding/removing/substituting a PCI ingredient to a Class 2 product: 30 day review
3) Adding/removing/substituting a PCI ingredient to a Class 3 product: 210 day review

Now that non-prescription drugs fall under the purview of the NNHPD (as of July 2013), in order to further align and streamline non-prescription product reviews, a 6 month pilot program has commenced August 11, 2014. In order to apply through this pilot program, the non-prescription Product must be supported in it’s entirety by a single monograph. This pilot program applies only to the following monographs:

 

  • Sunscreen Monograph – Version 2.0 (2013)
  • Acne Therapy (2006)
  • Anti-Dandruff Products (2006)
  • Antiseptic Skin Cleansers (2006)
  • Athletes Foot Treatments (1995)
  • Medicated Skin Care Products (2007)
  • Diaper Rash Products (2007)
  • Throat lozenges (1995)

For the time being, an applicant can obtain a copy of the Non-prescription Drug Monograph Attestation form by contacting the NNHPD (Email: nhpd_dpsn@hc-sc.gc.ca) directly as the form is not yet available online. Timelines to receive a DIN for a Non-prescription Drug will remain the same (as those outlined in the Guidance document for the Management of Drug Submissions).

Dicentra can assist License holders for reviewing their NHP Licenses (NPNs) to update and align with the current NHPD monographs, and may assist in the regulatory review and preparation of Monograph attestation forms for Non-prescription Drug product applications. dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.