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HUMAN REPRODUCTIVE TECHNOLOGY ACT 1991 - SECT 33

33 .         Conditions applicable to all licences and exemptions

        (1)         Every licence and every exemption shall at all times be subject to the general condition that the ethics and practices that should govern, and the procedures to be used in, the conduct of reproductive technology in so far as they — 

            (a)         are for the time being set out in — 

                  (i)         the Code; or

                  (ii)         where no relevant Rule has been brought into operation, directions;

                and

            (b)         are applicable to — 

                  (i)         every licence or exemption;

                  (ii)         a licence or exemption of that kind; or

                  (iii)         that licence or exemption, specifically,

                are to be observed by the licensee in relation to the reproductive technology practice carried on by the licensee.

        (2)         Every licence granted or exemption issued under this Part is subject to the conditions — 

            (a)         that the practice authorised thereby shall be carried on — 

                  (i)         under the supervision of the licence supervisor;

                  (ii)         only on the premises to which the licence or exemption relates; and

                  (iii)         in accordance with this Act and the terms, conditions and directions applicable,

                but in no other manner;

            (b)         that any authorised officer, on production if so required of the certificate issued under section 59 or other identification as such, shall be permitted to enter the premises to which the licence or exemption relates and inspect them, including any equipment or records, to observe any procedure and to take account of any human gametes, a human egg undergoing fertilisation or a human embryo, there;

            (c)         that every participant to be treated has been given a suitable opportunity to receive proper counselling about the implications of the treatment and has been provided with such relevant information as is proper;

            (d)         that the requirements of this Act as to the obtaining and recording of effective consents be complied with;

            (e)         that section 22(1) is complied with;

            (ea)         that the licensee maintains the accreditation required by section 29(5)(a);

            (f)         that proper records in relation to the practice, procedures and participants be maintained, in such manner and form and including such information about such matters as this Act or the terms or conditions of the licence or exemption may require or the CEO may by directions specify;

            (g)         that, where any human gametes, a human egg undergoing fertilisation or a human embryo is supplied to a person to whom another licence applies, that person shall be provided with such information additional to that otherwise required as the CEO may by directions specify;

            (h)         that the CEO shall be provided, in such form and at such times as directions may specify, with such copies of or extracts from records to which this Act relates, or other information for the purposes of this Act, as the CEO may by directions specify; and

            (j)         that no information shall be removed from any records maintained under the licence or exemption before the expiry of such period as may be prescribed for records of that kind, except with the written approval of the CEO.

        (3)         Every storage licence is subject to the conditions — 

            (a)         that human gametes, a human egg undergoing fertilisation or a human embryo shall be stored only if received or acquired from — 

                  (i)         a person to whom a licence applies; or

                  (ii)         a person who satisfies the licensee that they can give an effective consent to that storage;

            (b)         that a human egg undergoing fertilisation or a human embryo the development of which was brought about by an in vitro fertilisation procedure, otherwise than under the authorisation conferred by a practice licence held by the same licensee, shall be stored only if received or acquired from — 

                  (i)         another person to whom a licence applies; or

                  (ii)         a person who satisfies the licensee that they can give an effective consent to that storage;

            (c)         that human gametes, human eggs undergoing fertilisation or human embryos which are or have been stored shall not be supplied to a person unless that person is a person to whom a licence or an exemption applies, or the supply has been otherwise authorised under this Act; and

            (d)         that no human gametes, human egg undergoing fertilisation or human embryo shall be stored for longer than this Act authorises.

        [Section 33 amended by No. 17 of 2004 s. 27; No. 55 of 2004 s. 527; No. 28 of 2006 s. 270(2).]



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