Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue or gene therapy products (CTGTP).
Refer to our clinical trials section for the guidance documents.
Class 1 CTGTP notification
Register a Class 2 CTGTP
Dealer's licensing and certification
Report adverse events
Report or recall defective products
Advertisements and promotions
Certificate of a Pharmaceutical Product
Fees and turnaround time
Notified Class 1 CTGTP
Register of Class 2 CTGTP
Register of Licensed CTGTP Importers, Wholesalers and Manufacturers
Duties And Obligations