Irish Medicines Board Act 1995
Fees.
13.—F22[(1) The Minister may make regulations providing for—
(a) the payment to and recovery by the Board of fees in relation to any matter arising in connection with the performance of any of its functions under section 4,
(b) different fees, exemption from the payment of fees, the payment of fees by instalments and the waiver, remission or refund (in whole or in part) of fees—
(i) in relation to any such matter, and
(ii) in different circumstances or classes of circumstances or for different cases or classes of cases,
(c) without prejudice to the generality of paragraph (a), the payment to and recovery by the Board of fees in relation to any application under regulations made under section 32 for—
(i) a licence, authorisation or certificate, or
(ii) the amendment or renewal of any such licence, authorisation or certificate,
(d) without prejudice to the generality of paragraphs (a) and (c), the payment to and recovery by the Board of annual fees in relation to any such licence, authorisation or certificate which is not annually renewable, and
(e) without prejudice to the generality of paragraph (b), different fees, exemption from the payment of fees, the payment of fees by instalments and the waiver, remission or refund (in whole or in part) of fees—
(i) in relation to any such licence, authorisation or certificate or any such amendment or renewal, and
(ii) in different circumstances or classes of circumstances or for different cases or classes of cases.]
(2) Where under regulations under this section a fee is payable in respect of any F22[matter or application, the matter or application] shall be invalid and shall not be decided or otherwise dealt with, as may be appropriate, by the Board unless the Board is in receipt of the fee.
(3) Fees received by the Board under this Act shall be paid into or disposed of for the benefit of the Exchequer in such manner as the Minister for Finance directs.
(4) The Public Offices Fees Act, 1879, shall not apply to any fees charged under this Act.
F23[(5) Without prejudice to the generality of regulations which may be made under this section for the recovery by the Board of fees payable under the regulations, the Board may recover, as a simple contract debt in any court of competent jurisdiction, from the person by whom it is payable any fee or part thereof due and payable under the regulations.
(6) Any regulations made under this section and in force immediately before the commencement of section 15 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 shall, on and after that commencement—
(a) continue in force and be deemed to be made under this section as amended by that section, and
(b) be liable to amendment and revocation under this section accordingly.]
Annotations:
Amendments:
F22
Substituted (22.07.2007) by Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), s. 15(a), (b), S.I. No. 543 of 2007.
F23
Inserted (22.07.2007) by Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), s. 15(c), S.I. No. 543 of 2007.
Modifications (not altering text):
C6
Power of Board to charge fees extended (20.11.2013) by European Union (Cosmetic Products) Regulations 2013 (S.I. No. 440 of 2013), reg. 3(6).
Responsibility for functions under EU Regulation
3. (1) The national competent authority for the purposes of the EU Regulation shall be the Board.
...
(6) The Board may charge fees for its functions under the EU Regulation in accordance with regulations made under section 13(1) of the Act, read in conjunction with section 4(1)(v) of the Act.
...
C7
Power of Board to charge fees extended (1.01.2013) by European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (S.I. No. 543 of 2012), reg. 5(3).
Responsibility for functions under Directive
5. (1) Subject to paragraph (2), the functions of the State and of the competent authority under the Directive shall be performed by the IMB.
...
(3) The IMB may charge fees for its functions under the Directive and these Regulations in accordance with regulations made under s. 13(1) of the Act, read in conjunction with s. 4(1)(v) of the Act.
...
C8
Functions transferred and references to “Department of Finance” and “Minister for Finance” construed (29.07.2011) by Finance (Transfer of Departmental Administration and Ministerial Functions) Order 2011 (S.I. No. 418 of 2011), arts. 2, 3, 5 and sch. 1 part 2, in effect as per art. 1(2).
2. (1) The administration and business in connection with the performance of any functions transferred by this Order are transferred to the Department of Public Expenditure and Reform.
(2) References to the Department of Finance contained in any Act or instrument made thereunder and relating to the administration and business transferred by paragraph (1) shall, on and after the commencement of this Order, be construed as references to the Department of Public Expenditure and Reform.
3. The functions conferred on the Minister for Finance by or under the provisions of —
(a) the enactments specified in Schedule 1, and
(b) the statutory instruments specified in Schedule 2,
are transferred to the Minister for Public Expenditure and Reform.
...
5. References to the Minister for Finance contained in any Act or instrument under an Act and relating to any functions transferred by this Order shall, from the commencement of this Order, be construed as references to the Minister for Public Expenditure and Reform.
...
Schedule 1
Enactments
...
Part 2
1922 to 2011 Enactments
|
Number and Year |
Short Title |
Provision |
|
(1) |
(2) |
(3) |
|
... |
... |
... |
|
No. 29 of 1995 |
Irish Medicines Board Act 1995 |
Sections 9(7), 13(3) and 15 |
|
... |
... |
... |
Editorial Notes:
E4
Power pursuant to section exercised (21.12.2023) by Health Products Regulatory Authority (Fees) Regulations 2023 (S.I. No. 697 of 2023).
E5
Previous affecting provision: power pursuant to section exercised (15.12.2022) by Health Products Regulatory Authority (Fees) Regulations 2022 (S.I. No. 679 of 2022); revoked (21.12.2023) by Health Products Regulatory Authority (Fees) Regulations 2023 (S.I. No. 697 of 2023), reg. 5.
E6
Previous affecting provision: power pursuant to section exercised (21.12.2021) by Health Products Regulatory Authority (Fees) Regulations 2021 (S.I. No. 744 of 2021); revoked (15.12.2022) by Health Products Regulatory Authority (Fees) Regulations 2022 (S.I. No. 679 of 2022), reg. 5.
E7
Previous affecting provision: power pursuant to section exercised (17.12.2020) by Health Products Regulatory Authority (Fees) Regulations 2020 (S.I. No. 654 of 2020); revoked (21.12.2021) by Health Products Regulatory Authority (Fees) Regulations 2021 (S.I. No. 744 of 2021), reg. 5.
E8
Previous effecting provision: power pursuant to section exercised (20.12.2019) by Health Products Regulatory Authority (Fees) Regulations 2019 (S.I. No. 700 of 2019); revoked (17.12.2020) by Health Products Regulatory Authority (Fees) Regulations 2020 (S.I. No. 654 of 2020), reg. 5.
E9
Previous affecting provision: power pursuant to section exercised (11.12.2018) by Health Products Regulatory Authority (Fees) (No. 2) Regulations 2018 (S.I. No. 531 of 2018); revoked (20.12.2019) by Health Products Regulatory Authority (Fees) Regulations 2019 (S.I. No. 700 of 2019), reg. 5.
E10
Previous affecting provision: power pursuant to section exercised (19.06.2018) by Health Products Regulatory Authority (Fees) Regulations 2018 (S.I. No. 208 of 2018); revoked (11.12.2018) by Health Products Regulatory Authority (Fees) (No. 2) Regulations 2018 (S.I. No. 531 of 2018), reg. 5.
E11
Previous affecting provision: power pursuant to section exercised (5.12.2017) by Health Products Regulatory Authority (Fees) Regulations 2017 (S.I. No. 557 of 2017); revoked (19.06.2018) by Health Products Regulatory Authority (Fees) Regulations 2018 (S.I. No. 208 of 2018), reg. 5.
E12
Previous affecting provision: power pursuant to section exercised (6.12.2016) by Health Products Regulatory Authority (Fees) Regulations 2016 (S.I. No. 602 of 2016); revoked (5.12.2017) by Health Products Regulatory Authority (Fees) Regulations 2017 (S.I. No. 557 of 2017), reg. 5.
E13
Previous affecting provision: power pursuant to section exercised (17.12.2015) by Health Products Regulatory Authority (Fees) Regulations 2015 (S.I. No. 599 of 2015); revoked (6.12.2016) by Health Products Regulatory Authority (Fees) Regulations 2016 (S.I. No. 602 of 2016), reg. 5.
E14
Previous affecting provision: power pursuant to section exercised (23.12.2014) by Health Products Regulatory Authority (Fees) Regulations 2014 (S.I. No. 607 of 2014); revoked (17.12.2015) by Health Products Regulatory Authority (Fees) Regulations 2015 (S.I. No. 599 of 2015), reg. 5.
E15
Previous affecting provision: power pursuant to section exercised (17.12.2013) by Irish Medicines Board (Fees) Regulations 2013 (S.I. No. 501 of 2013); revoked (23.12.2014) by Health Products Regulatory Authority (Fees) Regulations 2014 (S.I. No. 607 of 2014), reg. 5.
E16
Previous affecting provision: power pursuant to section exercised (22.05.2013) by Irish Medicines Board (Fees) (Amendment) Regulations 2013 (S.I. No. 165 of 2013); revoked (17.12.2013) by Irish Medicines Board (Fees) Regulations 2013 (S.I. No. 501 of 2013), reg. 5.
E17
Previous affecting provision: power pursuant to section exercised (21.12.2012) by Irish Medicines Board (Fees) Regulations 2012 (S.I. No. 572 of 2012); revoked (17.12.2013) by Irish Medicines Board (Fees) Regulations 2013 (S.I. No. 501 of 2013), reg. 5.
E18
Previous affecting provision: power pursuant to section exercised (21.12.2011) by Irish Medicines Board (Fees) Regulations 2011 (S.I. No. 684 of 2011); revoked (21.12.2012) by Irish Medicines Board (Fees) Regulations 2012 (S.I. No. 572 of 2012), reg. 5.
E19
Previous affecting provision: power pursuant to section exercised (22.12.2010) by Irish Medicines Board (Fees) Regulations 2010 (S.I. No. 632 of 2010); revoked (21.12.2011) by Irish Medicines Board (Fees) Regulations 2011 (S.I. No. 684 of 2011), reg. 5.
E20
Previous affecting provision: power pursuant to section exercised (1.01.2010) by Irish Medicines Board (Fees) Regulations 2009 (S.I. No. 551 of 2009), in effect as per reg. 2; revoked (22.12.2010) by Irish Medicines Board (Fees) Regulations 2010 (S.I. No. 632 of 2010), reg. 5.
E21
Previous affecting provision: power pursuant to section exercised (1.01.2009) by Irish Medicines Board (Fees) Regulations 2008 (S.I. No. 542 of 2008), in effect as per reg. 2; revoked (1.01.2010) by Irish Medicines Board (Fees) Regulations 2009 (S.I. No. 551 of 2009), reg. 5, in effect as per reg. 2.
E22
Previous affecting provision: power pursuant to section exercised (1.01.2008) by rish Medicines Board (Fees) Regulations 2007 (S.I. No. 866 of 2007), in effect as per reg. 2; revoked (1.01.2008) by Irish Medicines Board (Fees) Regulations 2008 (S.I. No. 542 of 2008), reg. 7, in effect as per reg. 2.
E23
Previous affecting provision: power pursuant to section exercised (1.01.2007) by Irish Medicines Board (Fees) Regulations 2006 (S.I. No. 617 of 2006), in effect as per reg. 2; revoked (1.01.2008) by Irish Medicines Board (Fees) Regulations 2007 (S.I. No. 866 of 2007), reg. 7.
E24
Previous affecting provision: power pursuant to section exercised (1.01.2006) by Irish Medicines Board (Fees) Regulations 2005 (S.I. No. 882 of 2005), in effect as per reg. 2; revoked (1.01.2007) by Irish Medicines Board (Fees) Regulations 2006 (S.I. No. 617 of 2006), reg. 7, in effect as per reg. 2.
E25
Previous affecting provision: power pursuant to section exercised (1.01.2005) by Irish Medicines Board (Fees) Regulations 2004 (S.I. No. 877 of 2004), in effect as per reg. 2; revoked (1.01.2006) by Irish Medicines Board (Fees) Regulations 2005 (S.I. No. 882 of 2005), reg. 7, in effect as per reg. 2.
E26
Previous affecting provision: power pursuant to section exercised (31.08.2004) by Irish Medicines Board (Fees) (Amendment) Regulations 2004 (S.I. No. 524 of 2004); revoked (1.01.2005) by Irish Medicines Board (Fees) Regulations 2004 (S.I. No. 877 of 2004), reg. 7, in effect as per reg. 2.
E27
Previous affecting provision: power pursuant to section exercised (1.01.2004) by Irish Medicines Board (Fees) Regulations 2003 (S.I. No. 731 of 2003), in effect as per reg. 2; revoked (1.01.2005) by Irish Medicines Board (Fees) Regulations 2004 (S.I. No. 877 of 2004), reg. 7, in effect as per reg. 2.
E28
Previous affecting provision: power pursuant to section exercised (1.06.2002) by Irish Medicines Board (Fees) (Medicinal Products For Human Use) Regulations 2002 (S.I. No. 262 of 2002), in effect as per reg. 2; revoked (1.01.2004) by Irish Medicines Board (Fees) Regulations 2003 (S.I. No. 731 of 2003), reg. 7, in effect as per reg. 2.
E29
Previous affecting provision: power pursuant to section exercised (1.08.2000) by Irish Medicines Board (Fees) (Amendment) Regulations 2000 (S.I. No. 233 of 2000), in effect as per reg. 3; revoked (1.06.2002) by Irish Medicines Board (Fees) (Medicinal Products For Human Use) Regulations 2002 (S.I. No. 262 of 2002), reg. 7, in effect as per reg. 2.
E30
Previous affecting provision: exercised (19.02.1996) by Irish Medicines Board (Fees) Regulations 1996 (S.I. No. 44 of 1996), in effect as per reg. 5; revoked (1.06.2002) by Irish Medicines Board (Fees) (Medicinal Products For Human Use) Regulations 2002 (S.I. No. 262 of 2002), reg. 7, in effect as per reg. 2.