Distribution Centre:Health Canada Regulations & Guidelines
Overview
Health Canada is responsible for establishing standards for the safety and nutritional quality of all foods sold in Canada. The department exercises this mandate under the authority of the Food and Drugs Act and pursue its regulatory mandate under the Food and Drug Regulations.
uniPHARM is committed to following Health Canada and other government regulatory body mandates to ensure our company is following all provincial and federal standards, regulations, and laws.
Resources
Narcotic Control
The Narcotic Control Regulations require uniPHARM to be a licensed dealer and have a quality person in charge with certain requirements. More information can be found on the Narcotic Control Regulations page
The Directive On Physical Security Requirements For Controlled Substances goes over the licensed dealer's security requirements for the storage of controlled substances. The purpose of this directive is to ensure that minimum security requirements are met to prevent potential theft of controlled substances. More information can be found on the webpage here
Food & Drug
The Food and Drugs Act and the Food and Drug Regulations are mandates provided by the Government of Canada to protect the safety of Canadians from potential risks of certain food or drugs that may or may not follow established guidelines and regulations. More information can be found on the Food and Drugs Act page and the Food and Drug Regulations page.
Benzo's & Targeted Substances
uniPHARM follows the Controlled Drugs and Substances Act to ensure the company complies with all regulations including the proper disposal of controlled substances. More information can be found on the Controlled Drugs and Substances Act webpage.
Further, the Benzodiazepines and Other Targeted Substances Regulations is followed to comply with proper licensing, handling, classification, and destruction of targeted substances. More information can be found on the Benzodiazepines and Other Targeted Substances Regulations webpage.
Precursors
The Precursor Control Regulations are mandated under the Controlled Drugs and Substances Act and provides detailed content on the licensing, handling, transportation, and destruction of Class A and Class B precursors. More information can be found on the Precursor Control Regulations webpage.
Drug Recalls
The Natural Health Products Regulations are located on the Natural Health Products Regulations webpage.
The Recall Policy is located on the Recall Policy webpage.
Medical Device Recalls
Guide to Recall of Medical Devices.
The purpose of the guide is to assist in learning how to:
- keep medical device distribution records
- recall medical devices
- report medical device recalls to Health Canada
- write procedures for distribution record keeping and recall
Medical Device Inspection
How Health Canada inspects medical device establishments GUI-0064.
Guidance on Investigation of Reported Medical Device Problems GUI-0065.
Good Manufacturing Practices (GMP)
Guide 0069
Guidelines for Temperature Control of Drug Products during Storage and Transportation GUI-0069.
GMP Inspection
Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Version 2, GUI-0001.
GMP Inspection Policy for Canadian Drug Establishments including distributors and wholesalers every 36 months.
CAPDM - Temperature Control Best Practices
Please see person in charge for more information.
CAPDM - Safe and Secure Practices
Please see person in charge for more information.