Health Canada Forms

This document is a form for attesting the labels and packaging of over-the-counter medications sold in Canada.

This type of document is used for certification of presentations or applications for human drugs and/or disinfectants in Canada.

Aucune

This Form is used for listing and regulating patented medications in Canada. It is used to fill out a form for each patent by DIN.

This document is used for over-the-counter medications for listed diseases in Schedule A, excluding natural health products - Canada.

This document is used for certifying the translation of a product monograph in Canada.

This document is for pharmaceutical companies in Canada, providing them with a checklist for submissions of medications that comply with labeling standards or Category IV monographs. It is aimed at ensuring that regulatory compliance is met for drug labeling and presentation. It is provided in French.

This document is a template used for assessing the safety and efficacy of protocols in clinical trial applications in Canada. It helps ensure that the study follows proper guidelines and regulations to protect participants and gather reliable data.

This document is an safety assessment update for a sponsor in Canada. It includes an attestation from the sponsor.

This document is for the attestation of the promoter of generic drugs in Canada. It provides updates to the product monographs to ensure compliance with the PRC regulations.

This form is used for requesting fee remission and attesting the right to sell drugs in Canada.

This Form is used for requesting the emergency release of drugs in Canada.

This form is used for applying for a Veterinary Drug Experimental Studies Certificate (ESC) in Canada.

This type of document is used to request a meeting with Canadian authorities before submitting a formal application for a specific purpose.

This form is used for making administrative changes related to the certification of veterinary drugs in Canada.

This document is a template used in Canada to request reconsideration for human drugs.

This document is for attesting to the ethics approval from the Research Ethics Board in Canada. It is required for conducting research studies in compliance with ethical guidelines.

This type of document, Form 2.00.46E, is used for the Qualified Investigator Undertaking in Canada.

This form is used for the application fee for the Master File (Mf) for human drugs in Canada.

This form is used for submitting the application fee for the Master File (Mf) Application for Human Drugs in Canada.

This document is for applying for a Drug Master File (DMF) in Canada. It is used to provide information about the manufacturing, processing, and formulation of a drug product.

Aucun

This document is for sponsor attestation in Canada regarding the addition of indications to the product monograph for biosimilar products to align with the innovator product.

This form is used for submitting the application fee for the Master File (MF) Application for Human Drugs in Canada.

This document is for reporting expenses related to medications for human use in Canada.