UPDATE - Non-prescription drug monograph attestation pilot

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Please note that the Non-prescription Drug Monograph Attestation form is currently not available on the web. To obtain a copy of this form, please contact the Directorate directly.

Preface

The Natural and Non-prescription Health Products Directorate (NNHPD) has updated communication for the Non-prescription Drug Monograph Attestation Pilot on the Health Canada website.

The NNHPD invites sponsors to clarify concerns/questions regarding brand names in advance of filing a submission under the Non-prescription Drug Monograph Attestation Pilot (pilot). This will facilitate the efficiency of the pilot by limiting the administrative burden associated with brand name changes post-Drug Identification Number (DIN) issuance.

Note: A brand name may be identified as unacceptable if 1) products are identified with non-unique brand names or 2) products are identified with unacceptable brand names that are false or misleading (e.g. indication of false or unverified claim).

Sponsors, who wish to clarify the acceptability of a brand name in advance of filing a submission under the pilot, are encouraged to contact the NNHPD by email prior to filing a submission under the pilot.

Background

In July 2013, the review of non-prescription drugs and disinfectants was transferred to the Natural and Non-prescription Health Products Directorate (NNHPD). The goal of this transition was to align the pre-market review processes between both natural health products (NHPs) and non-prescription drug products. Since the amalgation, the NNHPD has focused on increasing efficiencies and aligning review processes for NHPs and non-prescription drugs, including for products supported by monographs.

In December 2013, The NNHPD has published The approach to natural health products outlining the three-class system for product licensing. In October 2014, a revision to the Management of Product Licence Applications (PLA) For Natural Health Products policy was published. These documents define Class I NHPs as those of highest certainty that are supported entirely by a single NHP monograph. They also introduced the concept of attestation for product licence applications and post-licensing changes supported by NHP monographs.

The NNHPD has been exploring the opportunity of aligning the pre-market review of non-prescription drug applications supported by a single monograph with the approach of NHPs. The NNHPD has assessed the extent to leverage advances on NHPs towards non-prescription drugs and has chosen to begin with the implementation of a six month Non-prescription Drug Monograph Attestation Pilot.

Scope

As of August 11, 2014, applicants with non-prescription drug products supported entirely by one (1) of the following eight (8) monographs must attest to meeting all the requirements under the established product monograph:Footnote 1

Attestation

Non-prescription drug applications subject to this pilot 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 Attestation form 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.

NOTE: The Non-prescription Drug Monograph Attestation form is available by request from NNHPD by email.

Drug Identification Number (DIN) issuance

The DIN issuance for an application subject to the Non-prescription Drug Monograph Attestation Pilot will be based on the information provided by the applicant on the Health Canada 3011 form.

Rejection notices

For the six month duration of the pilot, applicants will be given the opportunity to address administrative deficiencies identified in their application, but should be aware that this opportunity may not be provided in the future and that, following the pilot, non-prescription drug applications that are deemed deficient with respect to administrative content may be issued a Rejection Notice. Examples of areas of deficiency for non-prescription drug monograph applications include but are not limited to: omission of the attestation form; attesting to the wrong monograph; or missing information on the 3011 form. Applicants whose submissions are rejected based on administrative deficiencies may not be refunded their fees and may be required to resubmit their applications with applicable fees if they wish to pursue the application further.

Post-licensing quality control audit

To complement the attestation to monographs, this pilot will involve a post-licensing quality control audit. This will ensure that the parameters against which applicants have attested are accurately reflected in the DIN application, focusing on errors, inconsistencies and deviations from the monograph. The post-licensing quality control audit will be comprised of risk-based and random auditing streams. Following a failed audit, applicants will be notified via a Notice of Audit Failure and will be expected to submit a Post-authorization Division 1 Change (PDC) or appropriate submissions to correct any errors/changes. The NNHPD reserves the right to communicate the result of any failed audits on the Health Canada website or through other avenues (i.e. compliance enforcement).

Brand name issues

Under the pilot, a sponsor attests that the brand name of the product is "consistent with the DIN application, does not pose a risk to health and safety, and is not false or misleading." At the time of the audit, the brand name is reviewed. Based on the review, a brand name may be identified as unacceptable if 1) products are identified with non-unique brand names or 2) products are identified with unacceptable brand names that are false or misleading (e.g. indication of false or unverified claim).

As the audit is conducted post-DIN issuance, follow-up requiring a change to a brand name requires a new administrative submission, as well as additional cost associated with the submission.

In order to facilitate the efficiency of the pilot and limit administrative burden, while respecting the intent of the pilot to align the pre-market review of non-prescription drug applications supported by a single monograph with the approach of NHPs, the NNHPD invites sponsors to clarify concerns/questions regarding brand names in advance of filing a submission under the pilot. Sponsors, who wish to clarify the acceptability of a brand name in advance of filing a submission under the non-prescription drug monograph attestation pilot, are encouraged to contact the NNHPD by email prior to filing a submission under the pilot.

Questions and answers

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

Q1: Will the fees for an application in the Non-prescription Drug Monograph Attestation Pilot remain the same?

A1: Yes, the fees associated with an application subject to the Non-prescription Drug Monograph Attestation Pilot will remain the same for Drug Identification Number application-Labelling Standard submissions. For a current listing of fees, as of April 1, 2014, please consult the Pharmaceutical Submission and Application Review page.

Q2: Will the timeline to receive a DIN in the Non-prescription Drug Monograph Attestation Pilot remain the same?

A2: 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.

Q3: Are secondary sunscreen products included in this pilot?

A3: Yes, secondary sunscreen products are included in the Non-prescription Drug Monograph Attestation Pilot. However, the Sunscreen Monograph - Version 2.0 (2013) currently does not include labelling requirements for secondary sunscreen products. As a result, applicants submitting an application for a secondary sunscreen product should attest to the Sunscreen Monograph - Version 2.0 (2013) and meet all 2013 monograph requirements with the exception of Directions for Use and Risk Information for which applicants should meet the requirements of the Sunburn Protectants Monograph (2006). To obtain a copy of the Sunburn Protectants Monograph (2006) send a request to NNHPD by email.

Q4: Are changes or amendments to authorized DINs included in this pilot?

A4: During the course of the pilot, only new applications for a DIN - Category IV product (DINF) will be included in the scope of the attestation for those monographs outlined under the Scope section of this document. For all other submissions, including Post-authorization Division 1 Changes (PDC), refer to the Guidance for Industry: Management of Drug Submissions document for information on application requirements.

Q5: What if a non-medicinal ingredient in my product is not present in the Natural Health Products Ingredients Database (NHPID)?

A5: All medicinal (i.e. active) and non-medicinal ingredients in a Category IV DIN application must be present 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 the ingredient 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 an 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.

Next steps

Following the six month pilot, applicants should continue to submit Non-prescription Drug Monograph Attestation forms for products falling within the scope of this document. The NNHPD will continue to strive to increase efficiencies for pre-market review of non-prescription drug products. The NNHPD will continue to evaluate the success of the pilot and lessons learned to determine the future scope of appropriate product lines to follow.

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