How to Make a Complaint
Table of Contents
Who can submit a complaint?
The Guidelines for PMPRB Staff specify that the designated approved individuals and organisations who are able to submit complaints are:
- The Federal Minister of Health or any of their Provincial or Territorial counterparts; or
- Senior officials who are authorised to represent Canadian publicly funded drug programs.
What to submit?
To validate a complaint, the PMPRB requires sufficient information to verify the complainant’s eligibility as an approved individual, as specified in paragraph 68 of the Guidelines for PMPRB Staff, and to confirm its jurisdiction over the medicine. In this respect, the following information is required:
- Your name, title, organization, and contact information
AND (one of the combinations of information noted below)
- The brand name or product name of the medicine and the Drug Identification Number (DIN); or
- The brand name and the strength of the medicine; or
- The medicinal ingredient and strength of the medicine and the name of the pharmaceutical company selling the medicine.
Further details about the required information can be found in the Glossary below.
If your complaint pertains to various medicines or multiple strengths of the same medicine, the information specified above is required for each individual medicine for which you wish to submit a complaint.
Please note that if not enough information is received to confirm either your identity or the identity of the medicine for which the complaint is being submitted, PMPRB Staff may reach out to you to request the necessary information. Only necessary information will be requested.
Any additional information that you wish to submit, either concerning the identity of the medicine or regarding the circumstances for which you are submitting a complaint, may be included in your complaint. Optional additional information could include:
- The price of the medicine (excluding pharmacist fees);
- The province or territory for which the price applies;
- If the medicine is being provided under the Special Access Program (SAP) or the list of Drugs for an Urgent Public Health Need (UPHN); or
- If the medicine is considered to be a patented generic, over the counter, or veterinary medicine.
How to submit?
Your complaint may be submitted by any of the following methods:
By Email:
PMPRB.Complaints-Plaintes.CEPMB@pmprb-cepmb.gc.ca
Your email must either include:
- A signed document on your organization’s letterhead, as an attachment, including all the relevant information noted above (e-signatures accepted); or
- All the relevant information included in the body of the email, with a signature block that can clearly be identified as corresponding to the sender’s email address.
By mail:
Box L40
Standard Life Centre
333 Laurier Avenue West
Suite 1400
Ottawa, Ontario
K1P 1C1
The complaint may be submitted on your organization’s letterhead. Please ensure that the submitted document includes the signature or e-signature of the approved individual authorized to make the complaint.
If you require assistance submitting your complaint, use either of the numbers identified below to contact PMPRB Staff for assistance.
By Telephone or TYY:
- Toll-free: 1-877-861-2350
- TYY: 613-288-9654
What happens next?
When the PMPRB receives a complaint, Staff will verify that the complaint has been sent by an approved individual and that it pertains to a medicine under the PMPRB’s jurisdiction. If both verification criteria are not met, the matter will be closed. If it is determined that the complaint was submitted by an approved individual and pertains to a patented medicine, the PMRPB will begin an In-Depth Review into the price of the medicine.
The PMPRB will send an acknowledgement of receipt to the complainant. Due to limitations on disclosure set out in sections 87 and 88 of the Patent Act and in the Access to Information Act, the PMPRB can only inform the complainant of the outcome of an In-Depth Review if the process results in an Undertaking or a Notice of Hearing. Therefore, if the PMPRB concludes an In-Depth Review with no further action being taken (i.e., it is closed by the Chairperson), the PMPRB will only advise the Rights Holder and not the complainant, unless the Rights Holder consents to the PMPRB disclosing that information to the complainant.
The PMPRB cannot provide updates on the status of a complaint or on the progress of any associated In-Depth Review.
All In-Depth Reviews will proceed in the same manner, including those commenced due to a complaint. Generally, an In-Depth Review could take between 12 and 28 months to complete, depending on the complexity. The PMPRB will inform the Rights Holder of the start of the In-Depth Review but information about the complainant cannot be provided, unless required by law.
For questions about the complaints process, please contact PMPRB.Complaints-Plaintes.CEPMB@pmprb-cepmb.gc.ca
For general information or inquiries about the PMPRB, please contact PMPRB.Information-Renseignements.CEPMB@pmprb-cepmb.gc.ca
Glossary
Drug Identification Number (DIN): A computer-generated eight-digit number assigned by Health Canada to a drug product prior to being marketed in Canada.
Brand/Product Name: The brand name is the unique name under which the manufacturer of a medicine advertises and sells it. This is the name used to distinguish the medicine sold by one manufacturer from that sold by another manufacturer.
Medicinal Ingredient(s): A medicinal ingredient, also known as an active ingredient, is any component that has medicinal properties, and is responsible for the action in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. It is the ingredient that, when used in the drug dosage form, provides the intended effect.
Example:
Tylenol is the brand name of a common over-the-counter medicine. Acetaminophen is the name of the medicinal or active ingredient found in Tylenol that provides the intended effect.
In some cases, multiple manufacturers produce their own version of the same medicine, containing the same medicinal ingredient. When this occurs, it is common practice for the product name to be composed of a prefix identifying the company and the name of the medicinal ingredient. For example, if two manufacturers called “ABC Pharmaceuticals” and “XYZ Pharmaceuticals” both produced an acetaminophen, their product names might respectively appear on a prescription label as “ABC-Acetaminophen” and “XYZ-Acetaminophen”.
Strength: The amount of the active/medicinal ingredient in each single dosage form of the drug.
Example:
150 mg/vial
1mg/milliliter
40 mg/tablet
Pharmaceutical Company: The manufacturer of the medicine.