Reply To: CR Clinical Packaging Requirements


Rhys Evans
Participant

Reply To: CR Clinical Packaging Requirements

Hi David,

There is nothing in the regulations that states CR packaging is mandatory in Canada.

I assume that the patient is taking home the medicine in which case it is recommended you include a ‘keep out of reach of children’ statement on the label.

Hope this helps.
Rhys

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html