Management of Notifications regarding Class B Precursor Registration Closure
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Organization: Health Canada
Published: 2020-02-XX
Table of Contents
- Purpose
- Scope
- Communicating with the OCS
- Before submitting a notification regarding a registration closure
- Processing a notification regarding a registration closure
- Unsolicited information
- Table A - service standard for processing notifications regarding closure of class b precursor dealer's registrations
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 B Precursor Registration 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 B Precursor Dealer's Registration Closure
NOTE:
* Business-as-usual closure: the closure of a Class B Precursor Dealer's Registration notified by the regulated party prior to, or following the expiry of their registration. The closure is considered to be business-as-usual only are no outstanding security or compliance issues associated with the regulated party or their facility.
* Not business-as-usual closure: all situations where the registration closure is not considered to be business-as-usual. Not business-as-usual closures will be processed on a case-by-case basis, and the closure process will be adapted to support their specific circumstances. There is no defined service delivery standard for not business-as-usual closures, as they require a more customized approach. Service time lines will be based on a mutual agreement, where possible.
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 registration closures. Notifying dealers may contact the Authorization Divisions 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:
- Generic e-mail accounts are monitored daily on working days, and e-mails are assigned to the appropriate Officer.
- An automatic acknowledgment reply is generated for all e-mails received.
- 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.
- The OCS may adapt its first in first out approach to the prioritization of notifications, on a case-by-case basis.
- Unless pursuant to a mutual agreement, notifications which are sent by regular mail will be rejected with original documents being returned, and all remaining information being shredded.
4. Before submitting a notification regarding a registration 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 B 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 registered 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 registration closure
All information and data submitted in support of a registration closure remains the property of Health Canada.
All business-as-usual registration closure notifications are processed through four stages, INTAKE, REVIEW, REGISTRATION CLOSURE, and OUT-TAKE, as illustrated below. All notifications are processed on a first-in first-out basis.
The OCS targets the processing of business-as-usual notifications regarding Class B Dealer Registration closure through these process stages within the service standard* time frame of 30 calendar days.
*NOTE:
The service standard for Registration Closures does not apply to notifications that are considered as not business-as-usual registration closures.
Refer to Table A, Section 7.0 - Service Standard for Processing Notifications Regarding Closure of Class B Precursor Dealer's Registration, for further details regarding service standards.
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 registration 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.
5.3 Registration closure
During REGISTRATION CLOSURE, the documents related to the registration closure undergo final review.
The OCS targets to complete REGISTRATION CLOSURE within FIVE (5) calendar days following the completion of REVIEW.
The REGISTRATION CLOSURE respecting a notification will result in:
- a registration Closure Letter from Health Canada addressed to the Senior Person in Charge; and
- the revocation of Dealer's registration.
Following the successful completion of REGISTRATION CLOSURE the notification will proceed to OUT-TAKE.
5.4 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's e-mail address 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 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 registration that the new information pertains to.
7. Table A
| Notification Type | Notification Process Stages | Regulatory Outcome | Overall Service Standard Calendar Days |
|||
|---|---|---|---|---|---|---|
| Intake | Review | REGISTRATION CLOSURE | Out-take | |||
| Business-as-usualFootnote * Class B Precursor Dealer's Registration Closure | 5 Calendar Days | 15 Calendar Days | 5 Calendar Days | 5 Calendar Days | Dealer's Registration Revocation | 30 |
|
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