Open Government Portal

Found 7370 records

The AHR Act forbids the buying and selling of in vitro embryos in Canada.

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Prohibitions purchasing reproductive material purchasing or selling In Vitro Embryos donors of human reproductive material and in vitro embryos use human reproductive material vitro embryos assisted human reproduction Act the AHR Act

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: guidance document drug submissions new drug submissions policy on bioequivalence standards highly variable drug products comparative bioavailability requirements pharmacokinetic

This guidance document provides sponsors of subsequent entry inhaled corticosteroid (ICS) products for the treatment of asthma with information on …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: guidance document data requirements safety and effectiveness inhaled corticosteroid products asthma treatment of asthma clinical data requirements

An antiseptic product is considered to be one that inactivates, reduces, prevents or arrests growth of microorganisms with the inherent …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: guidance document human-use antiseptic drugs inactivates or arrests growth of microorganisms mitigate or prevent disease

The purpose of this guidance document is to provide hospitals with information that may be useful in achieving compliance with …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: hospitals mandatory reporting adverse drug reactions medical device incidents Food and Drug Regulations Medical Devices Regulations

This guidance document provides source establishments with assistance on how to comply with adverse reaction reporting obligations under the Food …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: guidance document source establishments reporting adverse reactions safety human cells tissues organs

Donor sperm and ova (eggs) are sperm and ova that are intended for use in assisted human reproduction (AHR) by …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Donor sperm or ova (eggs) assisted human reproduction Assisted Human reproduction Act the AHR Act

The Regulatory Operations and Enforcement Branch of Health Canada is responsible for compliance and enforcement activities related to the Assisted …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Assisted Human Reproduction Act the AHR Act compliance and enforcement

Blood establishments fall into one or more of three groups based on risk and must have the proper Health Canada …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Blood blood for transfusion blood establishments manufacture of a drug

In spite of this, rumours persist that question both the safety and viability of Canada's blood and plasma supply. This …

Record Modified: Jun 1, 2021
Record Released: Jun 1, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Blood regulation plasma plasma donation blood and plasma products collection blood safety issues infectious diseases blood supply paid donors