Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 47A

  (1)   In this regulation:

"delegation" means a delegation, under subsection   57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:

  (a)   paragraph   19(1)(a), relating to specified therapeutic goods;

  (b)   paragraph   32CK(1)(d), relating to specified biologicals;

  (c)   paragraph   41HB(1)(d), relating to a specified medical device or a kind of medical device.

  (2)   A delegation may only be to a person who:

  (a)   is a medical practitioner registered in a State or Territory and employed by an institution that has an ethics committee; and

  (b)   subject to subregulation   (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection   57(3) of the Act.

  (3)   If:

  (a)   a person proposes another person under paragraph   (2)(b) as a person to be a delegate; and

  (b)   that other person becomes a delegate;

the first - mentioned person must supervise each approval that the delegate grants under the delegation.

  (4)   A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.

  (5)   A delegation may be made for the purpose of allowing the delegate to grant an approval in relation to:

  (a)   a particular item of therapeutic goods; or

  (b)   a particular class of therapeutic goods; or

  (c)   a particular biological; or

  (d)   a particular class of biologicals; or

  (e)   a particular medical device; or

  (f)   a particular kind of medical device;

for treating a specific illness or condition.

  (6)   A delegate may grant an approval under a delegation only if:

  (a)   a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and

  (b)   an ethics committee has agreed to the granting of approval under paragraph   19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.