Authorized Owner

For the purpose of administering the Act, the Authorized Owner category only includes businesses authorized under an enactment of BC or Canada to manufacture a drug or natural health product, such as holders of valid drug establishment or site licences issued by Health Canada.

Authorized Owners are already permitted to own, use or possess Controlled Equipment under the Act by virtue of their licensing under another regulatory regime. 

Authorized Owners must provide an Equipment Notification by July 1, 2019.

 

Before you start your confirmation process

The Registrar will conduct a simple confirmation process to verify the validity of the drug establishment or site licence issued to your business. Before you notify the Registrar of your Authorized Owner status, please note the following:

  • Authorized Owner notification is done through the Pill Press Online Registry, which requires a Business BCeID for access. If a business does not already possess a Business BCeID, they can initiate an online BCeID registration at www.bceid.ca
  • Authorized Owners are only authorized to manufacture a drug or natural health product as per the terms of their valid drug establishment or site licence.
  • If an Authorized Owner is using Controlled Equipment to manufacture products other than drugs or natural health products (as per their Health Canada licence), the business must obtain a Waiver to manufacture these other products.
 

Authorized Owner Confirmation Process

To receive confirmation of your status as an Authorized Owner, you must notify the Registrar through the Pill Press Online Registry following these five steps:

 

step 1

Authentication:  Use a Business BCeID to log in.

step 2

Client Dashboard: From the Dashboard, you may select an Authorized Owner Notification or an Equipment Notification (link enabled once your Authorized Owner status is confirmed). The status of Notifications is tracked on the Dashboard.

step 3

Business Profile Review: A first-time visitor will be invited to fill out business profile information, such as addresses and contact information. The business profile should be periodically updated as business information changes.

step 4

Authorized Owner Notification: This Notification requires the following information:

  • Currently own, use or possess (or intend to own) Controlled Equipment either for sole use or to provide manufacturing services to others.
  • Purpose of Controlled Equipment including producing a product, borrowing, renting or leasing, or selling.
  • Legislative authority (e.g. Food and Drugs Act), type of authorization (e.g. drugs) and license type (Drug Establishment Licence or Site Licence).

step 5

Notification Submission: Review and confirm that the information provided is complete, honest, and accurate.

 

After submitting your Notification

Once the Registrar confirms that you meet the requirements for Authorized Owner status, you will receive an email notice and be invited to provide your Equipment Notification.

Obligations and Responsibilities of Authorized Owners

Notification of Equipment

Acquisition of equipment

Suspended, replaced, or cancelled licences

Changes to Controlled Equipment


Notification of Equipment

Authorized Owners are responsible to notify the Registrar of any piece of Controlled Equipment they own, use or possess by adding them to the Authorized Owner’s inventory in the Pill Press Registry. Authorized Owners can see their inventory of Controlled Equipment on their client Dashboard.

Acquisition of equipment

When Authorized Owners acquire a piece of Controlled Equipment, they must report the transaction to the Registrar through the Pill Press Online Registry within 10 days and provide the following information:

  • The date on which the Authorized Owner acquired the Controlled Equipment.
  • A description of the Controlled Equipment including make, model, serial number and/or equipment registry number.
  • Whether the Controlled Equipment was acquired from a BC Registered Seller, along with the seller’s registration number; or, if not acquired from a BC Registered Seller, the seller’s legal name and civic address.
  • The civic address where the acquired Controlled Equipment will ordinarily be stored.
  • Method of payment used.

If the seller is in BC, the Registrar will await Equipment Notification from the Registered Seller before transferring the piece of Controlled Equipment from the seller’s inventory to the purchaser’s inventory on the Pill Press Registry.

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Suspended, replaced, or cancelled licences

Authorized Owners whose Health Canada licensing status has changed after July 1, 2019, must report these circumstances to the Registrar. If the business’ drug establishment or site licence has been suspended, replaced, or cancelled, the business must report this to the Registrar within 10 days, by sending an email to PillPressLicensing@gov.bc.ca, and awaiting further instructions.

Changes to Controlled Equipment

Authorized Owners have an ongoing obligation to notify the Registrar about the following changes to their Controlled Equipment:

Sale:

Authorized Owners who wish to sell their Controlled Equipment must apply for a Registered Seller registration. If a business acts as a broker or supplier of alternative ownership arrangements (i.e. renting, leasing, lending) for Controlled Equipment, these are considered controlled activities. Please refer to the Registered Seller page for more information.

Location:

Any change to the location where a piece of Controlled Equipment is ordinarily stored must be reported to the Registrar, and updated on the Authorized Owner’s equipment inventory on the Pill Press Registry.

Lost, Stolen, or Destroyed:

If a piece of Controlled Equipment is lost, stolen, or destroyed, it must be reported to the Registrar, and updated on the Authorized Owner’s equipment inventory on the Pill Press Online Registry.

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