HOW TO ACCESS THE 714X IN CANADA
The sale of 714X is restricted from sale in Canada. If you are a Canadian resident, below is the legal process in Canada to access the 714X product manufactured by CERBE Laboratory.
This product has a special status in Canada and is not available over the counter or available in pharmacies by prescription, like any other pharmaceutical product.
714X is available under the Food and Drug Regulations C.08.010(1) under the Government of Canada’s Food and Drugs Act under Health Canada’s Special Access Programme (SAP) as of December 19, 1989.
To legally obtain 714X in Canada, here is the procedure to apply for it:
1- Make sure you are accompanied by a practitioner with a right to practice in a Canadian province. Only they are authorized to file an access
request with Health Canada.
2- Review and print the following documents. Give them to your practitioner on your next visit.
a) The Special Access Program – Drugs:
b) General information from Health Canada’s Special Access Program: Applying for a drug:
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
c) The Special Access Program request form:
3- Your practitioner must complete the form: Special Access Program Form A – Patient specific request – C08.010(1), sign it and date
the access request.
4- Once the form has been completed, the physician will send:
a) A signed copy without cover sheet to Health Canada/Special Access Program, Therapeutic Products Directorate by fax to 613-941-3194. For after-hours requests and urgent situations requiring immediate attention, please contact the SAP by phone at 613-941-2108.
b) The same signed copy with the fax receipt sent to Health Canada to the attention of CERBE Laboratory, manufacturer of 714X, by fax at 819-564-4668.
5- Once the access request has been filled with Health Canada, the Special Access Program office will inform your practitioner of the status of the application, whether or not it is accepted. Your practitioner may also be asked for additional clarification before a final answer is given. Usually, Health Canada tries to process applications within one business day of receipt.
6- If the access request is granted, Health Canada will inform the manufacturer that they are authorized to deliver the product to your practitioner’s office address.
7- Your practitioner’s office will let you know that your request is granted. From then on, you can contact the official distributor of CERBE Laboratory, CERBE Distribution, to make the payment prior to the delivery of the product to your doctor.
8- The product will then be shipped to your practitioner’s office, and you will need to contact their office to pick it up. Please note that a user guide (official manufacturer’s procedure) will be included with the shipment of the product to assist you with the administration of the 714X.
If you have any questions, please do not hesitate to contact CERBE Distribution’s Customer Information and Support Service team by phone at: 819-564-7883 or 1-866-523-0758 (toll-free) or by email at: [email protected].
Novembre 2024