You can book a consultation with us to discuss specific regulatory requirements relevant/unique to your CTGTP or seek feedback on the appropriateness of specific supporting documents for your application.
Each consultation is limited to one CTGTP registration application and up to 1 hour in duration. Pre-market consultation fees apply.
Regulatory overview
Class 1 CTGTP notification
Register a Class 2 CTGTP
Variation applications
Dealer's notice
Dealer's licensing and certification
Risk management plan requirements
Report adverse events
Report or recall defective products
Clinical trials
Product consultation
Advertisements and promotions
Certificate of a Pharmaceutical Product
Duties And Obligations
Guidance documents
Fees and turnaround time
Notified Class 1 CTGTP
Register of Class 2 CTGTP
Register of Licensed CTGTP Importers, Wholesalers and Manufacturers
CTGTP E-services