Health Products (Clinical Trials) Regulations 2016 · As enacted · Part 2 · Clinical Trials of Therapeutic Products or Applicable Ctgt Products
10. Amendments and substantial amendments to clinical trial, etc.
Feedback & supportThe Authority may, at any time, direct the sponsor to make an amendment (including a substantial amendment) if it appears to the Authority that the amendment is necessary to ensure —
the safety or scientific validity of the clinical trial;
compliance with the principles of good clinical practice in relation to the clinical trial; or
compliance with the conditions of the Authority’s authorisation or acceptance of notification,and the sponsor must comply with the direction.
Subject to regulation 21, in the case of a clinical trial that has been authorised by the Authority under regulation 8, the sponsor must not make a substantial amendment, except with the approval of the Authority.
An application for approval of a substantial amendment referred to in paragraph (2) must be made by the sponsor in the form and manner specified on the Authority’s website.
Subject to regulation 21, in the case of a clinical trial that has been notified to the Authority under regulation 9, the sponsor must not make a substantial amendment until the substantial amendment has been notified to the Authority and the sponsor has received the Authority’s acceptance of the notification.
A notification of a substantial amendment referred to in paragraph (4) must be made by the sponsor in the form and manner specified on the Authority’s website.
The sponsor must —
keep records of all amendments; and
send such records, or copies of such records, to the Authority, in accordance with any request by the Authority for the same.
Subregulation 1
The Authority may, at any time, direct the sponsor to make an amendment (including a substantial amendment) if it appears to the Authority that the amendment is necessary to ensure —
the safety or scientific validity of the clinical trial;
compliance with the principles of good clinical practice in relation to the clinical trial; or
compliance with the conditions of the Authority’s authorisation or acceptance of notification,and the sponsor must comply with the direction.
Subregulation 2
Subject to regulation 21, in the case of a clinical trial that has been authorised by the Authority under regulation 8, the sponsor must not make a substantial amendment, except with the approval of the Authority.
Subregulation 3
An application for approval of a substantial amendment referred to in paragraph (2) must be made by the sponsor in the form and manner specified on the Authority’s website.
Subregulation 4
Subject to regulation 21, in the case of a clinical trial that has been notified to the Authority under regulation 9, the sponsor must not make a substantial amendment until the substantial amendment has been notified to the Authority and the sponsor has received the Authority’s acceptance of the notification.
Subregulation 5
A notification of a substantial amendment referred to in paragraph (4) must be made by the sponsor in the form and manner specified on the Authority’s website.
Subregulation 6
The sponsor must —
keep records of all amendments; and
send such records, or copies of such records, to the Authority, in accordance with any request by the Authority for the same.