Frequently Asked Question

7. What is the difference between applicant, principal and manufacturer?

According to the MCAZ CTD guideline, “applicantmeans the person or entity by whom, or on whose behalf, an application for registration is made. “Manufacturer” means a company that carries out operations such as production, packaging, repackaging, labelling and re-labelling of pharmaceuticals. “Principal” means the owner of the intellectual property for the medicine.