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Section 16B: Grant of application

Clinical Trials Act · PART VA: REGISTRATION CERTIFICATE

This section is inserted by Act No 13 of 2019, section 6.

consolidated text (as at 2017, amended since). juris shows the text as it was consolidated; it does not confirm that this is the law in force today.

16B. Grant of application (1) The Council may, when considering an application made under section 16A, require the applicant to furnish such additional information as may be necessary, within such time as it may determine. (2) The Council may grant an application under this Part where it is satisfied that the prescribed conditions are met. (3) On granting an application under subsection (1), the Council shall issue a registration certificate to the contract research organisation – (a) on such terms and conditions and for such duration as it may determine; and Acts 2019 275 (b) on payment of the prescribed registration fee. (4) The Council shall cause to be published in the Gazette and on the website of the Ministry, not later than 15 days after the issue of a registration certificate, the particulars of that certificate.

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