Adverse Reaction Reporting

Get expert solutions from us in preparing FDA and Health Canada adverse reaction reporting that is complete and accurate.

What is an Adverse Reaction Reporting?

Adverse Reaction reporting is mandatory in Canada and must be filed with Health Canada within 15 calendar days of receiving or becoming aware of the incident.  These can be submitted through fax, mail or by completing an online form. The success of Health Canada’s Adverse Reaction reporting system depends majorly on the completeness, quality, correctness and timelessness of the information submitted. Adverse drug reaction reporting may cause changes in decisions on regulatory actions such as withdrawal of a product from the Canadian market, health product effectiveness and imparting knowledge about health product safety that benefits all Canadians.

More than 6000 Licenses Successfully Delivered

Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada

Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

Why the Need for Adverse Reaction Reporting?

Healthcare relies primarily on the detection and reporting of suspected Adverse Drug Reporting or adverse reaction databases to identify new reactions and potential safety issues, detect factors that may increase risk, record the frequency with which they are reported and provide information to prescribers to prevent future ADRs. ADR is a method to improve health product safety for all Canadians. That’s why Health Canada has made adverse drug reaction reporting mandatory in Canada. 

Risks and Benefits of Drugs

Successful preparation and submission of ADR allow adding international data on the benefits, effectiveness or risks of drugs.

Product Safety Information

ADR enables Health Canada to provide and communicate changes in product safety information to industry, health care providers, hospitals, and consumers.

Regulatory Actions

Depending on ADR reporting, the agency may take regulatory actions, such as or removing a product from the Canadian market or change the product label.

Other Benefits

The Adverse reporting helps identify previously unrecognized, rare or serious adverse reactions or problems.

Why Us For Adverse Reaction Reporting Health Canada

At Quality Smart Solutions, you will get assistance from former Health Canada and FDA Officials. They will guide you about ADRs and even assist you in Grade 4 Adverse drug reaction reporting. Moreover, we have 15 years of industry experience. We support in multiple languages to serve our global customers. You can connect with our live chat compliance expert anytime, anywhere.

Do You Know?

Follow Latest News, Blogs & Industry Updates

Ensuring Predictability for Interim Orders Relating to COVID-19
December 15, 2020
| |

Ensuring Predictability for Interim Orders Relating to COVID-19

Health Canada recently published an additional notice regarding all interim orders relating to COVID-19...
Read More
Additional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers
October 9, 2020
| |

Additional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers

On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a...
Read More
FDA Announces FSMA Food Traceability Proposed Rule
September 25, 2020
| |

FDA Announces FSMA Food Traceability Proposed Rule

On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed...
Read More
Regulatory Considerations for Non-Medical Masks or Face Coverings
September 13, 2020
| |

Regulatory Considerations for Non-Medical Masks or Face Coverings

Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations...
Read More
Interim Order Respecting Clinical Trials Relating to COVID-19
June 6, 2020
| |

Interim Order Respecting Clinical Trials Relating to COVID-19

On May 23, 2020, the Minister of Health of Canada approved an Interim Order...
Read More
Clarifications and requirements regarding the interim measure for Hard Surface Disinfectants and Hand Sanitizers
May 29, 2020
| |

Clarifications and requirements regarding the interim measure for Hard Surface Disinfectants and Hand Sanitizers

In light of the current COVID-19 pandemic, Health Canada is taking action to increase...
Read More
What is HACCP and Food Handler’s Certification
April 26, 2020
| |

What is HACCP and Food Handler’s Certification

What is HACCP Plan Food safety is always evolving and becoming more complex, as...
Read More
How to Develop a HACCP Plan
April 21, 2020
| |

How to Develop a HACCP Plan

The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify...
Read More
Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices
April 15, 2020
| |

Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices

Recently in Canada, the Minister of Health has signed an Interim Order to allow...
Read More
COVID-19 FIGHT: Hand sanitizers and disinfectants compliance – Canada and US
March 23, 2020
| |

COVID-19 FIGHT: Hand sanitizers and disinfectants compliance – Canada and US

In light of the recent Coronavirus pandemic, the demand for antimicrobial products such as disinfectants...
Read More
Q&A: Selling Hand Sanitizers in Canada during COVID-19 pandemic
March 22, 2020
| |

Q&A: Selling Hand Sanitizers in Canada during COVID-19 pandemic

With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during...
Read More
Protecting Canadians from Unsafe Drugs Act
February 3, 2020
| |

Protecting Canadians from Unsafe Drugs Act

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that...
Read More
Do You Need Adverse Reaction Reporting Support?

Please complete the form below. We will respond to you soon.

Select all applicable Services
Select countries of interest