Adverse Reaction Reporting
It is of the utmost important to perform due diligence in record keeping
and documentation in order to stay compliant.
Cannabis falls as Schedule1 drug under the Federal classification both in Canada and US. The proper regulation of a controlled substance is critical to legalize cannabis and cannabis products which present a complex range of challenges and opportunities.
Cannabis Compliance Inc. helps individuals and organizations on how to enter the legal cannabis industry, by playing the role of an educator: educating our clients to be compliance with the regulatory framework, its creation, implementation and monitoring for setting high standards in the Medical Cannabis industry.
To understand the implications of adverse reaction reporting for Licenced Producers who specially are entering into ACMPR-regulated controlled substance medicinal use Cannabis can be a cumbersome effort. It sometimes can be a challenge to determine what constitutes an adverse reaction VS a serious adverse reaction. One of the main focus in ACMPR is on Adverse reaction reporting which is tightly monitored and regulated by Health Canada. Focus point in HC audits as it pertains to the safety of the medicinal cannabis consumer. All adverse reactions need to be recorded and reported to the Minister in the given timeframe. It is Mandatory to notify all serious adverse reactions to Health Canada within specified time limit.
Cannabis consultants Inc. provides expert guidance in how to comply with these regulations to report and fill the forms within given timeframe to Health Canada in the event of adverse or serious adverse reaction takes place. We also guide our clients how to do critical analysis and follow-up evaluation of an adverse event by gathering relevant information relating to the adverse reaction or serious adverse reaction. We help our clients with recommendations based on overall safety evaluation providing recommendations on how to mitigate health and safety risk and the rationale for such recommendations.
We provide regulatory guidance for presentation of line listing and summary report of critical analysis of all adverse reactions, safety issues or risk factors associated; reaction analysis; reaction severity analysis; comparative analysis of reporting rates using exposure estimates; details of any regulatory actions taken such as change / modification of risk information.
As per Health Canada: “Consumers/patients and health professionals can report adverse reactions (also known as side effects) to health products, including prescription and non-prescription medications, biologics, (includes biotechnology products, vaccines, fractionated blood products, human blood and blood components, as well as human cells, tissues and organs), natural health products and radiopharmaceuticals, to the Canada Vigilance Program.”
Due to this it is utmost important to do due diligence in record keeping and documentation.