Therapeutic Goods Legislation Amendment (Annual Charges Exemption) Regulation 2015

Link to law: https://www.comlaw.gov.au/Details/F2015L00778

 
Therapeutic Goods Legislation Amendment (Annual Charges Exemption) Regulation 2015
 
Select Legislative Instrument No. 75, 2015
I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation.
Dated 28 May 2015
Peter Cosgrove
Governor‑General
By His Excellency’s Command
Fiona Nash
Assistant Minister for Health
 
  
  
Contents
1............ Name................................................................................................... 1
2............ Commencement................................................................................... 1
3............ Authority............................................................................................. 1
4............ Schedules............................................................................................ 1
Schedule 1—Amendments                                                                                                2
Part 1—Main amendments                                                                                         2
Therapeutic Goods Regulations 1990                                                                     2
Part 2—Other amendments                                                                                      18
Therapeutic Goods (Medical Devices) Regulations 2002                                 18
Therapeutic Goods Regulations 1990                                                                   18
 
1  Name
                   This is the Therapeutic Goods Legislation Amendment (Annual Charges Exemption) Regulation 2015.
2  Commencement
                   This instrument commences on 1 July 2015.
3  Authority
                   This instrument is made under the Therapeutic Goods Act 1989.
4  Schedules
                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
Part 1—Main amendments
Therapeutic Goods Regulations 1990
1  Regulation 2
Insert:
turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).
2  Subdivisions 1 and 2 of Division 1 of Part 7
Repeal the Subdivisions, substitute:
Subdivision 1—Preliminary
43AAA  Meaning of turnover and when turnover is of low value
             (1)  For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.
             (2)  For this Division (other than Subdivision 3) and subject to regulation 43AABB:
                     (a)  a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and
                     (b)  a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.
Subdivision 1A—Time for payment of certain annual charges
43AAB  Time for payment of certain annual charges
Entry of goods in Register commencing in financial year
             (1)  For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:
                     (a)  if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or
                     (b)  if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC or 43AAD is applicable—on 15 September in the next financial year.
Entry of goods in Register commencing before start of financial year
             (2)  For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.
Note 1:       A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:
(a)    the person is exempt from liability to pay the charge for that financial year under Subdivision 2; or
(b)    the Secretary has waived the charge for that financial year under regulation 43AAH.
Note 2:       This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.
Subdivision 2—Exemption from liability to pay certain annual charges
43AABA  Purpose of this Subdivision
                   For section 44A of the Act, this Subdivision makes provision for and in relation to:
                     (a)  exempting a person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value; and
                     (b)  waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.
43AABB  Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015
             (1)  This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.
             (2)  The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.
             (3)  For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:
                     (a)  low value turnover;
                     (b)  turnover.
43AAC  Exemption from liability to pay certain annual charges—2015‑16 financial year
Therapeutic goods other than biologicals
             (1)  A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4) or (5) are met.
Entry of goods in Register commencing in 2015‑2016 financial year
             (2)  The requirements in this subregulation are met if:
                     (a)  the registration, listing or inclusion in the Register of the goods commenced in the 2015‑16 financial year; and
                     (b)  the person’s turnover of the goods for the 2015‑16 financial year is of low value; and
                     (c)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.
Entry of goods in Register commencing on or after 1 May 2015 and on or before 30 June 2015
             (3)  The requirements in this subregulation are met if:
                     (a)  the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and
                     (b)  the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and
                     (c)  the person’s turnover of the goods for the 2014‑15 financial year was of low value; and
                     (d)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and
                     (e)  the person’s turnover of the goods for the 2015‑16 financial years was of low value; and
                      (f)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.
Entry of goods in Register commencing on or after 1 July 2014 and on or before 30 April 2015
             (4)  The requirements in this subregulation are met if:
                     (a)  the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and
                     (b)  the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and
                     (c)  the person’s turnover of the goods for the 2014‑15 financial was of low value; and
                     (d)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and
                     (e)  the person’s turnover of the goods for the 2015‑16 financial years was of low value; and
                      (f)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.
Entry of goods in Register commencing on or before 30 June 2014
             (5)  The requirements in this subregulation are met if:
                     (a)  the registration, listing or inclusion in the Register of the goods commenced on or before 30 June 2014; and
                     (b)  the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 in which the goods were registered, listed or included in the Register; and
                     (c)  the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and
                     (d)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and
                     (e)  the person’s turnover of the goods for the 2015‑16 financial years was of low value; and
                      (f)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.
Biologicals
             (6)  A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:
                     (a)  the inclusion of the biological in the Register commenced in the 2015‑16 financial year; and
                     (b)  the person’s turnover of the goods for the 2015‑16 financial year is of low value; and
                     (c)  the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.
Note 1:       See regulation 43AAA for the meaning of turnover and when turnover is of low value.
Note 2:       A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).
Note 3:       If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.
Note 4:       If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.
Note 5:       If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.
43AAD  Exemption from liability to pay certain annual charges—financial years commencing on or after 1 July 2016
                   A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:
                     (a)  either:
                              (i)  the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or
                             (ii)  the registration, listing or inclusion in the Register of the goods commenced in the current financial year;
                     (b)  the person’s turnover of the goods for the current financial year is of low value;
                     (c)  the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.
Note 1:       See regulation 43AAA for the meaning of turnover and when turnover is of low value.
Note 2:       A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).
Note 3:       If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.
Note 4:       If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.
Note 5:       If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.
43AAE  Exemption from liability to pay certain annual charges—late notice that turnover was of low value
             (1)  This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.
             (2)  The person may, on or before 15 September in the next financial year, give the Secretary, in writing:
                     (a)  a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and
                     (b)  a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and
                     (c)  if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d) or (5)(d) was applicable.
Note:          A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).
             (3)  The documents given under subregulation (2) must be accompanied by the fee payable.
             (4)  The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:
                     (a)  the notice referred to in paragraph (2)(a); and
                     (b)  the declaration referred to in paragraph (2)(b); and
                     (c)  if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and
                     (d)  the fee referred to in subregulation (3).
             (5)  If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.
             (6)  If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:
                     (a)  states that the person is liable to pay the charge for the relevant financial year; and
                     (b)  states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:
                              (i)  the person did not give the documents to the Secretary by the required date;
                             (ii)  one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);
                            (iii)  the documents were not accompanied by the correct fee; and
                     (c)  specifies the date on which the charge for the relevant financial year becomes payable.
43AAF  Person may notify Secretary that turnover of goods for financial year will not be of low value
             (1)  This regulation applies in relation to the following:
                     (a)  therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;
                     (b)  therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;
                     (c)  a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.
             (2)  If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.
             (3)  As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.
Note:          If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).
43AAG  Secretary may notify person that annual charge is payable if turnover is not of low value
Goods entered in Register at any time in 2015‑16 financial year
             (1)  If:
                     (a)  therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and
                     (b)  the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and
                     (c)  the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and
                     (d)  the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;
the Secretary must give the person a written notice in accordance with subregulation (2).
             (2)  A notice given to a person under subregulation (1) must:
                     (a)  state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:
                              (i)  for the 2015‑16 financial year; or
                             (ii)  for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and
                     (b)  specify the date on which the relevant charge, or charges, become payable.
Goods entered in Register at any time in financial year commencing on or after 1 July 2016
             (3)  If:
                     (a)  therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and
                     (b)  the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and
                     (c)  the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and
                     (d)  the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;
the Secretary must give the person a written notice in accordance with subregulation (4).
             (4)  A notice given to a person under subregulation (3) must:
                     (a)  state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:
                              (i)  for the relevant financial year; or
                             (ii)  for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and
                     (b)  specify the date on which the relevant charge, or charges, become payable.
43AAH  Waiver of certain annual charges
Scope
             (1)  This regulation applies in relation to a person who is liable to pay:
                     (a)  an annual registration charge for registered goods that are medicines; or
                     (b)  an annual charge for inclusion in the Register for a financial year of:
                              (i)  a biological; or
                             (ii)  a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or
                            (iii)  an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.
Application for waiver of charge
             (2)  The person may apply to the Secretary, in writing, for the charge to be waived for a financial year.
             (3)  An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:
                     (a)  be made:
                              (i)  if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and
                             (ii)  in any other case—at any time during the relevant financial year; and
                     (b)  be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).
Note 1:       No application fee is payable.
Note 2:       A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).
Decision by Secretary
             (4)  Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:
                     (a)  to waive the charge for the financial year; or
                     (b)  to refuse to waive the charge for the financial year.
             (5)  In considering the application, the Secretary:
                     (a)  must take into account the information referred to in paragraph (3)(b); and
                     (b)  must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.
             (6)  Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.
             (7)  The Secretary may decide to waive the charge for a financial year only if the Secretary is satisfied that:
                     (a)  the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and
                     (b)  it is in the interest of public health for the entry in relation to the goods to remain on the Register; and
                     (c)  it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.
             (8)  For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:
                     (a)  the population who use the goods;
                     (b)  the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;
                     (c)  any health risks to the population who use the goods that may be associated with:
                              (i)  obtaining the goods through alternative means; or
                             (ii)  the use of alternative goods;
                     (d)  the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.
             (9)  The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).
Notice of decision
           (10)  As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.
           (11)  If the decision is to refuse to waive the charge for the financial year, the notice under subregulation (10) must:
                     (a)  set out the reasons for the decision; and
                     (b)  specify the date on which the charge for the financial year becomes payable.
Period during which decision has effect
           (12)  If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.
           (13)  If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.
3  Regulation 45A
Repeal the regulation.
4  Subregulation 48(1) (after paragraph (f) of the definition of initial decision)
Insert:
                    (fa)  paragraph 43AAH(4)(b);
5  Part 2 of Schedule 9 (table item 3AB)
Repeal the item, substitute:
 
3AB
Fee for a notice and declaration under subregulation 43AAE(2) relating to an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year:
 

 
(a) if the notice and declaration relate to not more than 5 entries in the Register
400

 
(b) if the notice and declaration relate to 6 or more entries in the Register
400 for the first 5 entries plus 50 for each additional entry

6  Part 2 of Schedule 9A (after table item 3)
Insert:
 
3A
Fee for a notice and declaration under subregulation 43AAE(2) relating to an exemption from liability to pay an annual charge for inclusion of a biological in the Register for a financial year:
 

 
(a) if the notice and declaration relate to not more than 5 entries in the Register
$400

 
(b) if the notice and declaration relate to 6 or more entries in the Register
$400 for the first 5 entries plus $50 for each additional entry

Part 2—Other amendments
Therapeutic Goods (Medical Devices) Regulations 2002
7  Regulation 8.1A
Omit “paragraph 41JA(j)”, substitute “paragraph 41JA(1)(j)”.
8  At the end of regulation 8.1A
Add:
                   ; (h)  matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of the Therapeutic Goods Regulations 1990 for exempting a person from liability to pay an annual charge for inclusion of the devices in the Register for a financial year, based on low value turnover of the devices;
                      (i)  matters relating to an application to the Secretary under regulation 43AAH of the Therapeutic Goods Regulations 1990 to waive the annual charge for inclusion of the devices in the Register for a financial year.
Therapeutic Goods Regulations 1990
9  Regulation 16AA
Repeal the regulation, substitute:
16AA  Information or documents that Secretary may require
Information or documents relating to registered goods
             (1)  For paragraph 31(1)(k) of the Act, the following matters are prescribed:
                     (a)  matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;
                     (b)  matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.
Information or documents relating to listed goods
             (2)  For paragraph 31(2)(h) of the Act, the following matters are prescribed:
                     (a)  the efficacy of the goods for the purposes for which the goods are to be used;
                     (b)  matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;
                     (c)  matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.
Information or documents relating to biologicals
             (3)  For paragraph 32JA(1)(p) of the Act, the following matters are prescribed:
                     (a)  matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;
                     (b)  matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.
10  After subregulation 48(2)
Insert:
          (2A)  A request under subregulation (2) may be accompanied by information in support of the request.
11  After subregulation 48(3)
Insert:
          (3A)  In reconsidering the initial decision:
                     (a)  the Minister must take into account any information referred to in subregulation (2A); and
                     (b)  the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.
          (3B)  Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.
          (3C)  If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:
                     (a)  is taken to be a decision of the Secretary (except for the purpose of any review of the substituted decision); and
                     (b)  has effect, or is taken to have had effect, on and from the date determined by the Minister.
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