Health Canada's Special Access Program
The SAP enables drugs that are not currently marketed in Canada to be requested by practitioners for the treatment, diagnosis, or prevention of serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The decision to authorize or deny a request for use of an unapproved drug is made on a case-by-case basis by Health Canada.
PharmAla Biotech, in concert with our manufacturing partners, is currently the only supplier of GMP LaNeo™ MDMA for human use in Canada.
More information:
Contact us at sap@pharmala.ca if you would like more
information on MDMA and the Special Access Program
Useful links:
Health Canada’s Guidance Document for Practitioners:
https://bit.ly/3HhYNg2
Special Access Program Application Form (English):
https://bit.ly/3JU6pax
Special Access Program Application Form (French):
https://bit.ly/3JMDQeN
Regulations Amending Certain Regulations Made Under
the Food and Drugs Act (Sale of a New Drug for Emergency
Treatment) and Regulatory Impact Analtsis Statement:
https://bit.ly/3hgUFCl