Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications - Canada

The Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications - Canada is a document that provides information on the payment requirements for submitting master files and applications for supplementary protection certificates for human and disinfectant drugs in Canada. It includes details on the payment methods, fees, and instructions for making advance payments for these submissions.

The Health Products and Food Branch of Health Canada files the advance payment details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications in Canada.

FAQ

Q: What are master files for human and disinfectant drugs?
A: Master files are confidential documents submitted by drug manufacturers to provide detailed information about the quality, safety, and efficacy of their products.

Q: Why are master files necessary?
A: Master files are necessary to support the regulatory review and approval process for drug products. They contain information that is not readily available in the public domain.

Q: What is a certificate of supplementary protection (CSP) application?
A: A certificate of supplementary protection is an extension of patent protection for eligible pharmaceutical products. The CSP application provides additional patent-like rights and exclusivity for a specific period of time.

Q: Why would a pharmaceutical company apply for a CSP?
A: Pharmaceutical companies apply for a CSP to extend the exclusivity period of their patent-protected products, allowing them to recover the investment made in developing new drugs.

Q: Who can apply for a CSP in Canada?
A: Only the patentee or its assignee can apply for a certificate of supplementary protection in Canada.

Q: What is the purpose of advance payment for these applications?
A: The purpose of advance payment is to cover the costs associated with reviewing and processing master files and CSP applications in a timely manner.