Pill press authorized owner category
The Authorized Owner Category is a term used in the Pill Press Online Registry to describe a business that is already permitted to own, use, or possess Controlled Equipment under the Act by virtue of their licensing under another regulatory regime. Manufacturers authorized to fabricate drugs or natural health products by virtue of a drug establishment licence or site licence issued by Health Canada are automatically Authorized Owners under the Act. However, to register their Controlled Equipment in the Pill Press Online Registry, Authorized Owners need to go through a simple confirmation process.
At this time, the provisions in the Act relating to authorized health professionals are not in force. As a result, authorized health professionals are not considered Authorized Owners under the Act. If a health professional wishes to own, use, or possess Controlled Equipment, they must apply for a Waiver.
Before an Authorized Owner can register its inventory of Controlled Equipment, the Registrar will conduct a confirmation process to verify the validity of the Health Canada drug establishment or site licence issued to the business. A business in the Authorized Owner Category is required to apply for confirmation through the Pill Press Online Registry. Only manufacturers with the licensed activity of “fabrication” or “manufacturing” on their Health Canada drug establishment or site licence are allowed to use Controlled Equipment to produce a product.
Even if a business is confirmed in the Authorized Owner Category (i.e. they hold a valid drug establishment or site licence issued by Health Canada), this does not authorize the business to manufacture other products. If a business 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.
In accordance with the Act and Regulation, Authorized Owners have a number of ongoing obligations and responsibilities, including:
- Notification of suspended, replaced, or cancelled Health Canada licence
- Notification of (existing) Controlled Equipment
- Acquisition of Controlled Equipment
- Changes to Controlled Equipment
Authorized Owners have an ongoing obligation to notify the Registrar, via email to PillPressLicensing@gov.bc.ca, if their drug establishment or site licence is suspended, cancelled, or replaced by Health Canada. Notice to the Registrar must be given within 10 days after the event, and must include the following, along with any prescribed records or information, if any, and any further information, including personal information, that the Registrar requires:
- The name shown on the Authorized Owner’s, or former Authorized Owner's, drug establishment licence or site licence, as applicable
- The drug establishment licence number or site licence number, as applicable, of the suspended or cancelled drug establishment licence or site licence
If the drug establishment licence or site licence was cancelled and replaced for administrative reasons only, the drug establishment licence number or site licence number (and the licence expiry date) of the replaced drug establishment or site licence.