9DVariation of entries in Register

#### 9D Variation of entries in Register (1) The Secretary may: (a) following a request by a person in relation to whom therapeutic goods are entered on the Register; or (b) on the Secretary’s own initiative; vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect. (1A) If: (a) a medicine is included in the part of the Register for goods known as provisionally registered goods; and (b) it appears to the Secretary that the quality, safety or efficacy of the medicine is unacceptable in relation to a class of persons; the Secretary may, on the Secretary’s own initiative, vary the entry in the Register in relation to the medicine: (c) to reduce the class of persons for whom the medicine is suitable or to change the directions for use; or (d) to add a warning, or precaution, that does not include any comparison of the medicine with any other medicine by reference to quality, safety or efficacy. > Note: The Secretary may also vary the product information relating to the medicine: see subsection 25AA(4). (1B) If: (a) a medicine is included in the part of the Register for goods known as provisionally registered goods; and (b) the Secretary makes a decision under subsection 29(9) to extend the provisional registration period for the medicine; the Secretary may, on the Secretary’s own initiative, vary the entry in the Register in relation to the medicine to reduce the class of persons for whom the medicine is suitable or to change the directions for use. > Note: The Secretary may also vary the product information relating to the medicine: see subsection 25AA(4). (1C) If the Secretary proposes to make a variation under subsection (1A) or (1B), the Secretary must: (a) give the person in relation to whom the medicine is registered written notice of the proposed variation and of the reasons for the proposed variation; and (b) give the person a reasonable opportunity to make a submission to the Secretary in relation to the proposed variation; and (c) if the person makes a submission in accordance with paragraph (b)—take the submission into account before making a decision whether or not to make the variation. (1D) Subsections (1A) and (1B) apply despite subsection 16(1). (2) If: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and (b) the only effect of the variation would be: (i) to reduce the class of persons for whom the goods are suitable; or (ii) to add a warning, or precaution, that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy; the Secretary must vary the entry in accordance with the request. (2A) Subsection (2), to the extent to which it relates to subparagraph (2)(b)(i), applies despite subsection 16(1). (2C) If: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods; and (b) the variation is of a kind specified in the regulations; and (c) the conditions (if any) specified in the regulations are satisfied; the Secretary must vary the entry in accordance with the request. (2D) Subsection (2C), to the extent that it relates to therapeutic goods that are registered, applies despite subsection 16(1). (3) If: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and (b) subsection (2) does not apply to the request; and (ba) subsection (2C) does not apply to the request; and (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used; the Secretary may vary the entry in accordance with the request. (3AA) If: (a) the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and (b) the only effect of the variation would be: (i) to reduce the class of persons for whom the biological is suitable; or (ii) to add a warning, or precaution, that does not include any comparison of the biological with any other therapeutic goods by reference to quality, safety or efficacy; the Secretary must vary the entry in accordance with the request. (3AC) If: (a) the person in relation to whom a biological is included in the Register has requested the Secretary to vary the entry in the Register that relates to the biological; and (b) the variation is of a kind specified in the regulations; and (c) the conditions (if any) specified in the regulations are satisfied; the Secretary must vary the entry in accordance with the request. (3A) If: (a) the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and (aa) subsection (3AA) does not apply to the request; and (ab) subsection (3AC) does not apply to the request; and (b) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the biological for the purposes for which it is to be used; the Secretary may vary the entry in accordance with the request. (3B) If: (a) a particular biological ceases to be a biological because of a determination under subsection 32A(3); and (b) the biological is included in the Register under Part 3‑2A; the Secretary must move the entry relating to the biological from the part of the Register for biologicals to whichever other part of the Register is applicable. (3C) If: (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and (b) the only effect of the variation would be: (i) to reduce the class of persons for whom the kind of medical device is suitable; or (ii) to add a warning, restriction or precaution, that does not include any comparison of the kind of medical device with any other therapeutic goods by reference to quality, safety or performance; the Secretary must vary the entry in accordance with the request. (3CB) If: (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary the entry in the Register that relates to the kind of medical device; and (b) the variation is of a kind specified in the regulations; and (c) the conditions (if any) specified in the regulations are satisfied; the Secretary must vary the entry in accordance with the request. (3D) If: (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and (b) subsection (3C) does not apply to the request; and (ba) subsection (3CB) does not apply to the request; and (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or performance of the kind of medical device for the purposes for which it is to be used; the Secretary may vary the entry in accordance with the request. (4) If: (a) particular therapeutic goods cease to be medical devices because of a declaration under subsection 41BD(3); and (b) those goods are included in the Register under Chapter 4 as a kind of medical device; the Secretary must move the entry relating to the goods from the part of the Register for medical devices to whichever other part of the Register is applicable. > Note: Variations to the Register also occur to give effect to limited cancellations of entries of kinds of medical devices from the Register: see subsection 41GO(2). Form and manner of requests (6) The Secretary may, by writing: (a) approve a form for particular kinds of requests under this section; and (b) approve the manner of making particular kinds of requests under this section. (7) If: (a) the Secretary has approved a form for, and the manner of making, a kind of request under this section; and (b) either: (i) the kind of request is one under subsection (3) and which, under the regulations, must be decided within 175 or 255 working days; or (ii) the kind of request is one prescribed by the regulations for the purposes of this subparagraph; then a request of that kind is not effective unless: (c) the request is in accordance with that form; and (d) the request contains the information required by that form; and (e) the request is made in that manner; and (f) any prescribed application fee has been paid; and (g) the request is accompanied by information that is: (i) of a kind determined under subsection (8); and (ii) in a form approved, in writing, by the Secretary. (8) The Secretary may, by legislative instrument, determine a kind of information for the purposes of subparagraph (7)(g)(i). > Note: See also subsection 33(3A) of the Acts Interpretation Act 1901.