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