Communication on changes to the Non-prescription Drug Monograph Attestation Process

Background

The Non-Prescription Drug Monograph Attestation Pilot was launched on August 11, 2014, by the Natural and Non-prescription Health Products Directorate (NNHPD), to assess the appropriateness of approving non-prescription Category IV Monograph products (DINF) through an attestation process. For the last year under the pilot, applications for non-prescription drug products supported entirely by one of the following eight (8) established product monographs have attested to meeting the requirements: Sunscreen Monograph; Acne Therapy; Anti-Dandruff Products; Antiseptic Skin Cleansers; Athletes Foot Treatments; Medicated Skin Care Products; Diaper Rash Products; or Throat Lozenges.

A new attestation form was developed and is required as part of the DINF application [along with label text, a completed application (i.e. 3011) and fee form]. Drug Identification Numbers (DINs) were issued following an attestation to one of the eight identified monographs. Within two (2) weeks of DIN issuance, all submissions were audited for compliance with the indicated monograph by the NNHPD. When deficiencies were identified, a Notice of Audit Failure was issued, with instructions for required submissions [i.e. Post DIN changes (PDCs) or new DINF/DINA applications] to correct deficiencies and comply with the monograph. 

Next Steps

As of January 15, 2016, the Non-prescription Monograph Attestation Pilot will be considered complete. Due to the unacceptable results of the pilot project (i.e. audit failure rate over 50%), Health Canada is revising the attestation process in order to ensure key elements are addressed prior to approval.

The NNHPD will validate the key elements of DINF submissions that presented the highest concern of non-compliance during the pilot project prior to DIN issuance. An element of attestation will still apply to aspects of the submission approval process. Target times and fees will not change.

Effective immediately, key elements of all Category IV DIN (DINF) submissions will be validated prior to DIN issuance to ensure compliance with the monograph. Should any inconsistency be identified between the application and the monograph listed in the application (e.g. unacceptable medicinal or non-medicinal ingredient, unacceptable brandname, missing warning statements, etc.), sponsors will be advised that their application does not meet the monograph stream and that they must either:

• 1) revise the application to conform with the monograph; or,
• 2) amend the application to conform with a non-DINF submission (i.e. appropriate forms and data). The required forms and submission process will remain unchanged.

The process improvements are intended not only to add greater certainty that products on the market are in compliance with the Food and Drugs Act and its Regulations, but also ensure appropriate labelling for safe use by Canadians. The improvements will also eliminate uncertainty for sponsors surrounding the final approved Terms of Market Authorization, as no follow-up requests will be made following DIN issuance. Sponsors will need to be prudent at the time of application to avoid unnecessary oversights, resulting in non-compliance between their submission and the monograph.

Sponsors are encouraged to ensure that applications are of high quality and comply with specifications outlined in the monographs prior to submission, and include a signed non-prescription drug monograph attestation form.

The knowledge gathered during the pilot project is valuable and the NNHPD will continue to assess incoming submissions and monitor compliance to monographs during the pre-DIN validation to help inform future decisions. As non-prescription and natural health products are regulated by the NNHPD, both product lines will be considered for consistency as a comprehensive approach under the new Framework.

Questions and Answers

Specific inquiries pertaining to the Non-prescription Drug Monograph Attestation Pilot can be sent to the NNHPD by email.

Q1: What is the process for submitting a DINF application for the eight (8) identified product types?

A1: Non-prescription drug applications supported entirely by one of the following eight (8) established product monographs must attest to meeting all the requirements:

• Acne Therapy (2016)
• Antiseptic Skin Cleansers (2016)
• Sunscreen Monograph - Version 2.0 (2013)
• Medicated Skin Care Products (2007)
• Diaper Rash Products (2007)
• Anti-Dandruff Products (2006)
• Athletes Foot Treatments (1995)
• Throat Lozenges (1995)

Applicants are required to submit the Non-prescription Drug Monograph Attestation form in place of the Category IV Drug Submission Certification. All other requirements of the application type will still apply as outlined in the Guidance for Industry: Management of Drug Submissions document.

Applicants signing the Non-prescription Drug Monograph Attestationform will be attesting to selling the product within the conditions of the attestation and confirming awareness that operating outside of the attestation may result in compliance and enforcement action.

Q2: Will the fees for a DINF application remain the same?

A2: Yes, the fees associated with DINF applications will remain the same for Drug Identification Number application-Labelling Standard submissions. For a current listing of fees, as of April 1, 2015, please consult the Pharmaceutical Submission and Application Review page.

Q3: Will the timeline to receive a DIN for DINF submissions remain the same?

A3: Yes, the timelines associated with an application subject to the Non-prescription Drug Monograph Attestation Pilot will respect those outlined in the Guidance for Industry: Management of Drug Submissions document.

Q4: What elements will be reviewed prior to DIN issuance?

A4: Based on the results noted during the Non-prescription Drug Monograph Attestation Pilot, key elements that presented the highest concern of non-compliance will be validated; these include active ingredients, non-medicinal ingredients, indications, brand names and warning statements.

Q5: Will there still be an attestation component?

A5: Yes, the current attestation form will still be required and sponsors are expected to fully comply with all specifications of the respective monographs.

Q6: What if a non-medicinal ingredient in my product is not present in the Natural Health Products Ingredients Database (NHPID)?

A6: All medicinal (i.e. active) and non-medicinal ingredients in a Category IV DIN application must be present in, and compliant with, the NHPID.

If an ingredient is not present in the NHPID, applicants must submit a request to have the ingredient added to the NHPID and await its addition to the database prior to submitting their DIN application. A request can be made for an ingredient to be added to the NHPID by completing a NNHPD Issue Form and sending it to the NNHPD by email. For additional information on how to complete and submit an Issue Form, please refer to the Issue Form Guide.