Arranging for a pre-market consultation

Each consultation is limited to one single product registration application and up to 1 hour in duration.

Step 1: Book appointment online

• When: Five months before the consultation. For example, you will have to book an appointment by 1 April for a consultation on 31 August.
• How to book: Access our online booking form.

Step 2: Documents submission

• When to submit: At least 30 working days before the consultation. Please submit the documents early to allow us ample time to review them before your consultation.
• What to submit: 
  • Completed consultation form: Appendix 2 Pre-Market Consultation for Class 2 Cell, Tissue or Gene Therapy Product Registration214 KB
  • Relevant information described in the form. 
• How to submit: Information to be provided by replying to the confirmation e-mail, or e-mail us with appointment booking reference number in the email subject.

Step 3: Request for information

We will review the documents submitted and may ask for more information via e-mail before the appointment. If you fail to provide the information requested by the required time, your appointment may be rescheduled or cancelled.