Other Information

Health Canada

• Directive on Physical Security Requirements for Controlled Substances (1999)

Drug Establishment License Holders

A Drug establishment license is required for all businesses in Canada engaged in any of the six activities related to the manufacturing and testing of all drugs in dosages form and bulk intermediates of radiopharmaceutical and biological drugs.  The six activities are:

• fabrication,
• packaging/labeling,
• importation,
• distribution,
• wholesale, and
• testing.

Definitions of these activities can be found in the Food and Drug Regulations - Amendment (Schedule No. 624) Establishment Licensing Framework or the Guidance Document on Establishment Licences, both of which are located on the Health Products and Food Branch Inspectorate website:
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/

Pharmacies selling or otherwise distributing pharmaceuticals to other pharmacies (even in small amounts) require an Establishment License.

The following businesses hold an Establishment License for drugs:
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/del_tc_e.html

• "Establishment license application form

• "Establishment License guidance document"

• Tobacco sales in pharmacies (August 2005)

• NAPRA Policy re: Temporary Pharmacy Closures (November 2001)

• Central-fill and Central Processing of Prescriptions
  This document, developed by the Canadian Association of Chain Drug Stores, proposes the implementation of central-fill and central processing technologies for prescription fulfillment in Canada. It was reviewed and accepted by the Registrars at the November 2002 meeting of NAPRA's Inter-provincial Pharmacy Regulatory Committee (IPRC).