Section 16D: Suspension or cancellation of registration certificate

16D. Suspension or cancellation of registration certificate (1) Subject to subsection (2), the Council may, after giving a contract research organisation written notice of its intention to suspend or cancel a registration certificate and allowing it not less than 14 days to make representations to the Council, suspend or cancel a registration certificate where – (a) the contract research organisation has, in connection with the clinical trial, registration certificate or application for the registration certificate, given false or misleading information; (b) the contract research organisation has breached any condition imposed under section 16B; or (c) it considers that the health, welfare, safety or protection of a subject is likely to be or has been compromised as a result of the negligence of the contract research organisation. 276 Acts 2019 (2) The Council shall cause to be published in the Gazette and on the website of the Ministry such particulars as it may determine of any registration certificate which is suspended or cancelled. (h) in section 17(4), by inserting, after the word “sponsor”, the words “, contract research organisation”; (i) in Part IX – (i) by deleting the heading and replacing it by the following heading – PART IX – REGISTERS (ii) in section 29, by deleting the word “Register” wherever it appears and replacing it by the words “register of clinical trials”; (iii) by adding the following new section –