Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products.
Refer to our clinical trials section for the guidance documents.
Register your product
Apply for post-approval variation
Listing of approvals and post-registration actions
Reclassify your product
Dealer's licensing and certification
Apply for retention, cancellation or transfer application
Report adverse events
Report or recall defective products
Retail pharmacy licensing
Advertisements and promotions
CPP and SLS
Medicines quality and compliance monitoring
Fees and turnaround time
PRISM (Therapeutic products)