Submission Certification for Human and Disinfectant Drugs - Canada

The Submission Certification for Human and Disinfectant Drugs in Canada is a process by which pharmaceutical companies submit their applications for approval to Health Canada. It ensures that the drugs and disinfectants meet the necessary criteria for safety, efficacy, and quality.

The Submission Certification for Human and Disinfectant Drugs in Canada is filed by the applicant or the drug manufacturer.

FAQ

Q: What is a submission certification?
A: A submission certification is a document required by Health Canada for certain human and disinfectant drugs.

Q: What is the purpose of a submission certification?
A: The purpose of a submission certification is to demonstrate that the drug has been assessed and meets the requirements for safety, efficacy, and quality.

Q: Who needs to submit a certification?
A: Manufacturers and importers of human and disinfectant drugs need to submit a certification.

Q: What information is included in a submission certification?
A: A submission certification includes details about the drug, its intended uses, and evidence of safety and efficacy.

Q: How do I submit a certification?
A: Certifications can be submitted electronically through the Health Canada Submission Certification Application (SCA) or by mail.

Q: What happens after a certification is submitted?
A: Health Canada reviews the certification and assesses the drug to ensure it meets the required standards.

Q: Are there fees associated with submitting a certification?
A: Yes, there are fees associated with submitting a certification. The amount depends on the type of drug and the submission pathway.

Q: How long does it take for Health Canada to review a certification?
A: The review time varies depending on the type of drug and the completeness of the submission. It can take several months.

Q: What if my certification is rejected?
A: If a certification is rejected, Health Canada will provide reasons for the rejection and offer guidance on what needs to be addressed.

Q: Can I sell a drug without a submission certification?
A: No, you cannot sell a drug in Canada without a submission certification unless it is exempted by Health Canada.