Cosmetics Alliance has been informed that Health Canada (HC) is seeking stakeholder input to learn more about the drug export landscape and inform a regulatory proposal impacting drugs manufactured in Canada solely for the purpose of export.
See HC’s letter to Stakeholders (including the consultation questions): FDA Section 37 Drug Exports Consultation
The regulatory proposal that HC is currently developing is under the authority set out in subsection 37(1.2) of the Food & Drugs Act (FDA) that would amend the F&D Regulations to extend the requirement for Drug Establishment Licensing and application of Good Manufacturing Practices to drugs manufactured in Canada intended solely for export. (Currently, drugs manufactured in Canada solely for the purpose of export are exempt under Section 37 of the FDA.)
Your feedback will also help HC understand whether the COVID-19 pandemic has or is expected to have an impact on this particular industry (i.e. drugs made in Canada but not sold in Canada).
HC has requested that those of our member companies who are impacted to please respond directly to their consultation questions (found in HC’s letter to Stakeholders: FDA Section 37 Drug Exports Consultation). This will help them learn more about the reasons you need or have needed section 37 of the FDA, and to better understand the potential impacts to your business. Please send responses via email to hc.hpil.consultation-ipsop.sc@canada.ca by August 28, 2020. If you prefer to discuss your responses by phone, please indicate so by sending an email.
