Irish Medicines Board (Miscellaneous Provisions) Act 2006

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PART 4

Amendment of Control of Clinical Trials Act 1987

Amendment of section 1 of Control of Clinical Trials Act 1987 (interpretation).

21.— Section 1(1) of the Control of Clinical Trials Act 1987 is amended—

(a) by inserting after the definition of “administered” the following:

“‘ authorised officer ’ means an authorised officer appointed under section 15A(1);”;

(b) by inserting the following after the definition of “ethics committee”:

“ ‘ Irish Medicines Board ’ means the Irish Medicines Board established under section 3 of the Irish Medicines Board Act 1995 ;

‘ medical device ’ means medical device within the meaning of section 1(1) of the Irish Medicines Board Act 1995 ;”;

and

(c) by inserting the following after the definition of “participant”:

“ ‘ premises ’ includes any aircraft, hovercraft, ship, stall or vehicle;

‘ record ’ includes, in addition to a record in writing—

(a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form,

(b) a film, tape or other device in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and

(c) a photograph,

and any reference to a copy of a record includes—

(d) in the case of a record to which paragraph (a) of this definition applies, a transcript of the sounds or signals embodied therein,

(e) in the case of a record to which paragraph (b) of this definition applies, a still reproduction of the images embodied therein, and

(f) in the case of a record to which paragraphs (a) and (b) of this definition apply, such a transcript together with such a still reproduction;”.