Form 4.12E Master File (Mf) Application Fee Form for Human Drugs - Canada

Form 4.12E Master File (MF) Application Fee Form for Human Drugs is used in Canada to request payment of application fees for master files related to human drugs. It is a form that needs to be completed and submitted along with the required fee when applying for a master file for a human drug in Canada.

In Canada, the Form 4.12E Master File (Mf) Application Fee Form for Human Drugs is filed by the drug manufacturer or sponsor.

FAQ

Q: What is Form 4.12E Master File (Mf) Application Fee Form?
A: Form 4.12E is an application fee form for Master Files (MF) for human drugs in Canada.

Q: What is a Master File (MF) for human drugs?
A: A Master File (MF) is a confidential document that contains detailed information about the manufacturing, quality control, and stability of a drug substance or drug product.

Q: What is the purpose of the Form 4.12E Master File (Mf) Application Fee Form?
A: The purpose of this form is to request and pay the application fee for submitting a Master File (MF) for human drugs in Canada.

Q: Who needs to fill out this form?
A: Pharmaceutical companies or drug manufacturers who are submitting a Master File (MF) for human drugs in Canada need to fill out this form.

Q: What is the fee for submitting a Master File (MF) for human drugs?
A: The fee for submitting a Master File (MF) for human drugs in Canada varies depending on the type of submission and the size of the file. Please refer to the Health Canada Fee Form for more information.

Q: Are there any exemptions or waivers for the application fee?
A: There are no exemptions or waivers for the application fee for Master Files (MF) for human drugs in Canada.

Q: How should the application fee be paid?
A: The application fee can be paid by credit card, cheque, or money order. Detailed instructions for payment are provided on the Form 4.12E Master File (Mf) Application Fee Form.

Q: Is the application fee refundable?
A: No, the application fee for Master Files (MF) for human drugs in Canada is non-refundable.