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Management of Notifications regarding Class A Precursor Licence Closure

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Organization: Health Canada

Published: 2020-02-XX

Table of Contents

  1. Purpose
  2. Scope
  3. Communicating with the OCS
  4. Before submitting a notification regarding a licence closure
  5. Processing a notification regarding a licence closure
  6. Unsolicited information
  7. Table A - service standard for processing notifications
    regarding closure of class A precursor dealer's licenses

1. Purpose

The purpose of this policy is to outline the manner in which the Office of Controlled Substances (the OCS) manages business-as-usual notifications regarding Class A Precursor Licence closures, submitted in accordance with the Controlled Drugs and Substances Act, and the Precursor Control Regulations.

This policy also outlines the responsibilities and expectations of notifying dealers before and throughout the processing of the closure notification.

2. Scope

This policy applies to the following type of notification:

  • Business-as-usual* Class A Precursor Dealer's Licence Closure

NOTE:

* Business-as-usual closure: the closure of a Class A Precursor Dealer's Licence notified by the regulated party prior to, or following the expiry of their licence. The closure is considered to be business-as-usual only if there is no precursor stock on site at the time of the closure and there are no outstanding security or compliance issues associated with the regulated party or their facility.

* Not business-as-usual closure: all situations where the licence closure is not considered to be business-as-usual.

3. Communicating with the OCS

All information dealing with notifications identified in the SCOPE section is to be sent via e-mail to hc.precursors-precurseurs.sc@canada.ca . The OCS communicates with notifying dealers through generic e-mail accounts for receiving and processing notifications regarding licence closures. Notifying dealers may contact the Authorization Division general phone number 613-954-4760 and be redirected to the appropriate administrative section, if there is a need to speak with an OCS representative.

NOTES:

  1. Generic e-mail accounts are monitored daily on working days, and e-mails are assigned to the appropriate Officer.
  2. An automatic acknowledgment reply is generated for all e-mails received.
  3. E-mails which are sent directly to an OCS employee, including CC'ed and BCC'ed, will be deleted without return notification. If the notifying dealer knows the name of the OCS representative who is already working on their notification, the OCS representative's name should be identified in the body of any e-mail being sent via the generic e-mail account.
  4. The OCS may adapt its first in first out approach to the prioritization of notifications, on a case-by-case basis.

4. Before submitting a notification regarding a licence closure

It is important to be aware of the following information before filling a notification:

  • It is the notifying dealer's responsibility to be familiar with the Legislative and Regulatory requirements which govern Class A Precursors, as identified in the PURPOSE section of this policy. Access to the most current version of these documents is available through the Department of Justice website, http://laws-lois.justice.gc.ca/eng/acts/, and http://laws-lois.justice.gc.ca/eng/regulations/.

Reminder:

If a licensed dealer intends to close a site at which one or more precursors are kept, it is the dealer's responsibility to notify the OCS, at least 30 calendar days before the closure date.

5. Processing a notification regarding a licence closure

All information and data submitted in support of a licence closure remains the property of Health Canada.

All business-as-usual licence closure notifications are processed through five stages, INTAKE, REVIEW, LICENCE CLOSURE INSPECTION (if applicable), LICENCE CLOSURE, and OUT-TAKE, as illustrated below. All notifications are processed on a first-in first-out basis.

Figure 1. Processing an application.
Figure 1 - Processing a notification

The OCS targets the processing of business-as-usual notifications regarding Class A Dealer Licence closure through these process stages within the service standard* time frame of 30 calendar days.

* NOTE: The service standard for Licence Closures does not apply to the following:

  • notifications that are considered as not business-as-usual licence closures;
  • if it is determined by the Health Canada Regulatory Operations and Enforcement Branch (the ROEB) that a closure inspection will be conducted; or
  • if it is determined by the ROEB that a Health Canada inspector must witness the on-site destruction of remaining precursor inventory.

Refer to Table A, Section 7.0 - Service Standard for Processing Notifications Regarding Closure of Class A Precursor Dealer's Licenses, for further details regarding service standards.

In addition to notifying the OCS of intended site closure, closures related to the relocation of a licensed site also require the submission of a new Class A Precursor Dealer's Licence application. The OCS will issue a new licence number to the new site following the review of the new application and closure notification. In these cases, the OCS will work with the licensed dealer to determine the preferred licence closure date to ensure minimal impact on regulated activities. Refer to the document, Management of Applications for Class A Precursor Dealer Licence, for additional information related to the submission of a new Class A Precursor Dealer's Licence application.

Important Tip:

It is important for the notifying dealer to respond as quickly and as thoroughly as possible to requests for additional information throughout the processing of the closure notification. Response due dates will be identified in every request. The OCS will consider requests for extension supported by valid rationale.

Correctly completed response to additional information and statements requests benefits to both the notifying dealer and the OCS, some of which include:

  • ensures clearly legible information, reducing the likelihood of errors in data entry;
  • ensures adherence to the regulations; and
  • enables efficient processing and faster response times.

The OCS cannot commit to the service standards outlined in this policy when notifying dealer does not respond to requests for additional information by the specified due date.

5.1 Intake

All licence closure notifications are received and processed for tracking purposes. Additional information and statements will be requested from the notifying dealer via e-mail, before REVIEW is initiated. An in-depth review of the information provided is not performed during INTAKE.

The OCS targets to complete INTAKE within FIVE (5) calendar days of receipt of a closure notification.

Notifications that have successfully passed INTAKE will proceed to REVIEW.

5.2. Review

Notifications at REVIEW are subject to a thorough review to verify the content of the information and statements provided. The OCS targets to complete REVIEW within FIFTEEN (15) calendar days of a notification completing INTAKE.

Where information deficiencies or questions are identified, the OCS will contact the notifying dealer via e-mail identifying the issues to be addressed, in a Request for Additional Information.

NOTE:

The OCS will only place a licence closure notification on hold whenever it is determined by the ROEB that a closure inspection is required to be conducted. While a notification is on hold, the OCS will not count the elapsed time towards the overall service standard time frame related to the processing of a notification between the date when the licence closure inspection request is made, and the date when the licence closure inspection report is received by the OCS.

5.3 Licence closure inspection (if applicable)

A licence closure inspection is scheduled to confirm information, which may include the following:

  • the validity of additional information and statements regarding licence closure provided to the OCS;
  • there is no precursor inventory remaining on-site; and
  • there are no outstanding non-compliance and security issues.

The ROEB will contact notifying dealer directly to schedule a licence closure inspection following the request from the OCS. The OCS does not provide specific time lines or dates as to when the ROEB will be in contact or when inspections will be conducted.

As applicable, both REVIEW and LICENCE CLOSURE INSPECTION must be completed prior to moving on to LICENCE CLOSURE.

5.4 Licence closure

During LICENCE CLOSURE, the documents related to the licence closure undergo final review.

The OCS targets to complete LICENCE CLOSURE within FIVE (5) calendar days following the completion of REVIEW and LICENCE CLOSURE INSPECTION (if applicable).

The LICENCE CLOSURE respecting a notification will result in:

  • a licence Closure Letter from Health Canada addressed to the Senior Person in Charge; and
  • the revocation of Dealer's licence.

Following the successful completion of LICENCE CLOSURE the notification will proceed to OUT-TAKE.

5.5 Out-take

During OUT-TAKE, appropriate documents are processed for the e-mail communication to the notifying dealer. It is the notifying dealer's responsibility to ensure that changes to the Senior Person in Charge and/or Responsible Person in Charge's e-mail addresses are communicated to the OCS during the processing of the notification.

The OCS targets to complete OUT-TAKE within FIVE (5) calendar days.

Final documents are sent to the Senior Person in Charge and Responsible Person in Charge via e-mail.

Copies of all correspondence and documentation gathered related to the closure are maintained by the OCS for a period of five (5) years, in accordance with Library and Archives Canada, record retention and disposition frame work.

6. Unsolicited Information

Notifying dealers may submit, at any time during the processing of a closure notification, unsolicited information pertaining to any aspect of the submitted notification. The OCS reserves the right to accept or not accept the unsolicited information based on the status of the notification review. If the information is relevant, it will be documented and processed. If the information is irrelevant, it will be shredded. Before shredding, the notifying dealer will be informed whether the unsolicited information is being accepted or not accepted, together with the reasons why.

Whenever updated information is being submitted, it is the responsibility of the notifying dealer to clearly identify the relevant licence that the new information pertains to.

7. Table A

Service standard for processing notifications
regarding closure of class A precursor dealer's licenses
Notification Type Notification Process Stages Regulatory Outcome Overall Service Standard
Calendar Days
Intake Review LICENCE CLOSURE Out-take
Business-as-usual* Class A Precursor Dealer's Licence Closure 5 Calendar Days 15 Calendar Days 5 Calendar Days 5 Calendar Days Dealer's Licence Revocation 30

The service standard for Licence Closures does not apply to the following:

  • notifications that are considered as not business-as-usual licence closures;
  • if it is determined by the ROEB that a closure inspection will be conducted; or
  • if it is determined by the ROEB that a Health Canada inspector must witness the on-site destruction of remaining precursor inventory.

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