Irish Medicines Board Act 1995

Regulations.

32.—(1) The Minister may by regulations make such provision as he or she considers necessary or expedient for the purposes of this Act.

(2) Without prejudice to the generality of subsection (1), regulations under this section may, in relation to medicinal products for human use F26[, cosmetic products or medical devices], make provision for—

(a) the regulation (including the control) of the manufacture, production, preparation, importation, distribution, sale, supply, F27[administration,] placing on the market, advertisement or promotion of the product or products F27[, or the device or devices,] to which the regulations relate,

(b) the prohibition of the manufacture, preparation, importation, distribution, sale or offering or keeping for sale of the product or products F27[, or the device or devices,] to which the regulations relate either absolutely or subject to specified conditions (including the granting by the Board of licences for the manufacture, preparation, importation, distribution or sale of such product or products F27[or such device or devices]),

(c) the prohibition of the advertisement of the product or products F27[, or the device or devices,] to which the regulations relate either absolutely or subject to specified conditions (including the grant by the Board of a licence F26[, authorisation or certificate for such product or products or such device or devices]) and the prohibition of the sale or offering or keeping for sale of any such product F26[or products or such device or devices which is or are] advertised in contravention of such regulations,

(d) the regulation and control of the packaging and labelling of the product or products F27[, or the device or devices,] to which the regulations relate and, in particular, for the specification of information relating to such product or products F27[, or such device or devices,] to be contained on any packet used in the sale, supply or distribution of such product or products F27[, or such device or devices,] or on a label attached to such packet,

(e) the determination of the classes of persons to whom licences F27[, authorisations or certificates] under the regulations are to be granted,

(f) the specification of conditions for the grant, suspension, retention, amendment or renewal of licences F27[, authorisations or certificates] under the regulations,

(g) the refusal or revocation of licences F27[, authorisations or certificates] under the regulations,

(h) the requiring of applicants for or holders of licences F27[, authorisation or certificates] under the regulations to furnish specified information in regard to the constitution, manufacture, importation, storage, distribution, sale or advertisement of the product or products F27[, or the device or devices,] to which their applications or licences F27[, authorisations or certificates] relate,

F26[(i) the issuing of notices by authorised officers, within the meaning of section 32A, to the owners, occupiers or operators of premises requiring such owners, occupiers or operators to cease an activity—

(i) relating to the product or products, or the device or devices, to which the regulations relate, and

(ii) which, in the opinion of the authorised officer concerned, may pose a risk to human or animal health,

(j) subject to subsection (9), the specification that a reference to the supply of a medicinal product in—

(i) any regulations made under this section (whether made before, on or after the commencement of subsection (7)), or

(ii) any regulations referred to in section 34(4),

includes the administration of the product,

(k) subject to subsection (10), the prohibition of the administration of a medicinal product, or a class of medicinal products, specified in the regulations except by a member of a relevant profession in his or her capacity as such member, or—

(i) by a person, or a class of persons, specified in the regulations (which may be, or include, a person, or a class of persons, concerned in the provision of a health service, whether the health service is provided in a hospital, nursing home or clinic or otherwise), and

(ii) in accordance with the conditions, if any, specified in the regulations in relation thereto,

(l) subject to subsection (11) and without prejudice to the generality of any regulations made under paragraph (k), the prohibition of the sale or other supply of a medicinal product, or class of medicinal products, specified in the regulations except—

(i) pursuant to a prescription issued by a member of a relevant profession in his or her capacity as such member,

(ii) pursuant to a prescription issued by a registered nurse—

(I) who—

(A) is specified in the regulations as being a registered nurse who may, or

(B) belongs to a class of registered nurses specified in the regulations as being a class of registered nurses any member of which may,

issue a prescription in relation to the medicinal product, or class of medicinal products, as the case may be, concerned, and

(II) in accordance with such conditions, if any, as are specified in the regulations in relation thereto,

(iii) by such person, in or for such emergency circumstances and in accordance with such conditions, if any, as are specified in the regulations in relation thereto,

(m) the regulation and control of medicinal products that are subject to classification under Article 70 of Directive 2001/83/EC of 6 November 2001¹² and, in particular, in the case of such a medicinal product the classification of which is a medicinal product not subject to medical prescription, the prohibition of the sale or other supply of the medicinal product except—

(i) by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts 1875 to 1977 and in accordance with such conditions, if any, as are specified in the regulations in relation thereto, or

(ii) subject to subsection (12), by a person other than a person referred to in subparagraph (i) and in accordance with such conditions, if any, as are specified in the regulations in relation thereto,

(n) without prejudice to the generality of section 3 (1) of the European Communities Act 1972, giving effect to acts of the institutions of the European Communities relating to medicinal products for human use, cosmetic products or medical devices,

(o) such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations.]

F26[(3) Without prejudice to the generality of subsection (2)(o), regulations under subsection (2)(n) may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary for the purposes of the regulations (including provisions repealing, amending or applying, with or without modification, other law, exclusive of this Act).

(4) A person who contravenes a regulation under this section shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a fine not exceeding €2,000 or imprisonment for a term not exceeding one year or both,

(b) on conviction on indictment—

(i) in the case of a first offence, to a fine not exceeding €120,000 or imprisonment for a term not exceeding 10 years or both,

(ii) in the case of any subsequent offence, to a fine not exceeding €300,000 or imprisonment for a term not exceeding 10 years or both.]

(5) An offence under this section may be prosecuted by the Minister, the Board, the Pharmaceutical Society of Ireland or the health board in whose functional area the offence is committed.

(6) Notwithstanding subsection (4) of section 10 of the Petty Sessions (Ireland) Act, 1851, summary proceedings for an offence under the section may be instituted within two years from the date of the offence.

F27[(7) Any reference (howsoever expressed) to the supply of a medicinal product in—

(a) any regulations made under this section (whether made before, on or after the commencement of this subsection), or

(b) any regulations referred to in section 34(4),

shall not include the administration of the product unless it is otherwise specified pursuant to subsection (2)(j).

(8) Subject to subsection (13), regulations made under this section may specify that a reference (howsoever expressed) to the sale or supply of a medicinal product or medical device in—

(a) the regulations, or

(b) other regulations made under this section (including made before the commencement of this subsection), or referred to in section 34(4), which the first-mentioned regulations amend,

include the giving of the product or device, as the case may be, whether with or without payment, in the course of the provision of a health service (whether the health service is provided in a hospital, nursing home or clinic or otherwise).

(9) The Minister shall only make regulations under this section to provide for a specification referred to in subsection (2)(j) if the Minister, after having had regard to the nature and purpose of the medicinal product concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the specification is in the best interests of the persons to whom the product is usually administered.

(10) The Minister shall only make regulations under this section to provide for a prohibition and exception to the prohibition referred to in subsection (2)(k) if the Minister, after having had regard to the nature and purpose of the medicinal product, or class of medicinal products, concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the prohibition and exception to the prohibition is in the best interests of the persons to whom the medicinal product, or class of medicinal products, as the case may be, is usually administered.

(11) The Minister shall only make regulations under this section to provide for a prohibition and exception to the prohibition referred to in subsection (2)(l) if the Minister, after having had regard to the nature and purpose of the medicinal product, or class of medicinal products, concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the prohibition and exception to the prohibition is in the best interests of the persons to whom the medicinal product, or class of medicinal products, as the case may be, is usually administered.

(12) The Minister shall only make regulations under this section to provide for the exception referred to in subsection (2)(m)(ii) if the Minister, after having had regard to the nature and purpose of the medicinal product concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the medicinal product to be sold or otherwise supplied by a person other than a person referred to in subsection (2)(m)(i).

(13) The Minister shall only make regulations under this section to provide for a specification referred to in subsection (8) if the Minister, after having had regard to the nature and purpose of the medicinal product or medical device concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that the specification is in the best interests of the persons to whom the product or device, as the case may be, is usually given in the course of the provision of a health service.

(14) In this section, "relevant profession" means—

(a) for the purposes of subsection (2)(k), any profession a member of which may, before the commencement of this subsection, and in his or her capacity as such member, have lawfully administered a medicinal product,

(b) for the purposes of subsection (2)(l), any profession a member of which may, before the commencement of this subsection, and in his or her capacity as such member, have lawfully issued a prescription for a medicinal product.]

Annotations

Amendments:

F26

Substituted (1.05.2007) by Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), s. 16(a)(i), (iv)(II), (III), (viii), (b), S.I. No. 194 of 2007. A fine of €2,000 translates into a class C fine, not greater than €2,500, as provided (4.01.2011) by Fines Act 2010 (8/2010), ss. 3, 6(3) and table ref. no. 1, S.I. No. 662 of 2010.

F27

Inserted (1.05.2007) by Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), s. 16(a)(ii)(I), (II), (iii)(I), (II), (iv)(I), (v)(I), (II), (vi), (vii)(I)-(III), (c), S.I. No. 194 of 2007.

F28

Substituted by Health (Miscellaneous Provisions) Act 2024 (23/2024), s. 9(a)(i), (a)(ii)(I), (c), not commenced as of date of revision.

F29

Inserted by Health (Miscellaneous Provisions) Act 2024 (23/2024), s. 9(a)(ii)(II), (b), not commenced as of date of revision.

Modifications (not altering text):

C13

Prospective affecting provision: subs. (2)(k), (l) amended, subs. (11A) inserted and subs. (14) substituted by Health (Miscellaneous Provisions) Act 2024 (23/2024), s. 9(a)-(c), not commenced as of date of revision.

...

F28[(i) by a registered pharmacist, or a person, or class of persons, specified in the regulations, being a suitably qualified person or class of persons—

(I) concerned in the provision of a health service, whether the health service is provided in a hospital, nursing home, clinic, retail pharmacy business (within the meaning of the Pharmacy Act 2007) or otherwise,

(II) registered with a relevant professional body, and

(III) trained in the administration of the medicinal product,

and]

(ii) in accordance with the conditions, if any, specified in the regulations in relation thereto,

(i) ...

(ii) ...

(II) in accordance with such conditions, if any, as are specified in the regulations in relation F28[thereto,]

(iii) ...

F29[(iv) subject to subsection (11A), such medicinal product or class of medicinal products as may be used for the purpose of treating mild or moderate illnesses or ailments, pursuant to a prescription issued by a registered pharmacist—

(I) who has reached the required standard of education and training in relation to prescribing medicinal products in accordance with the rules of the Council of the Pharmaceutical Society of Ireland made under section 11(3A) of the Pharmacy Act 2007,

(II) where the prescription is issued under the governance of a retail pharmacy business (within the meaning of the Pharmacy Act 2007) in accordance with regulations made under section 18 of the Pharmacy Act 2007, and

(III) in accordance with such other rules made, and codes of conduct drawn up by the Council of the Pharmaceutical Society of Ireland under sections 7(2)(a)(iii) and 11 of the Pharmacy Act 2007, or

(v) subject to subsection (11A), by a registered pharmacist, in accordance with such conditions as are specified in the regulations in relation thereto,]

...

F29[(11A) Before making regulations under section 32(2)(l)(iv) or (v), the Minister shall consult the Health Service Executive and the Council of the Pharmaceutical Society of Ireland, and may consult any other person or body as he or she considers appropriate.]

...

F28[(14) In this section—

"relevant profession" means—

(a) for the purposes of subsection (2)(k), any profession a member of which may, before the commencement of section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 , and in his or her capacity as such member, have lawfully administered a medicinal product,

(b) for the purposes of subsection (2)(l), any profession a member of which may, before the commencement of section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 , and in his or her capacity as such member, have lawfully issued a prescription for a medicinal product;

"relevant professional body" means—

(a) the Dental Council established under section 6 of the Dentists Act 1985,

(b) the Nursing and Midwifery Board of Ireland referred to in section 6 of the Nurses and Midwives Act 2011,

(d) the Physiotherapists Registration Board established by section 26 of the Health and Social Care Professionals Act 2005,

(e) the Podiatrists Registration Board established by section 26 of the Health and Social Care Professionals Act 2005,

(f) the Radiographers Registration Board established by section 26 of the Health and Social Care Professionals Act 2005, or

(g) the Pre-Hospital Emergency Care Council established by the Pre Hospital Emergency Care Council (Establishment) Order 2000 (S.I. No. 109 of 2000).]

C14

References to "pharmaceutical chemist" construed (29.11.2008) by Pharmacy Act 2007 (20/2007), s. 75, S.I. No. 487 of 2008.

Interpretation of references to pharmaceutical chemists, persons keeping open shop, etc.

75.— (1) Any reference (however expressed) in a prior enactment to a pharmaceutical chemist registered under the Pharmacy Act (Ireland) 1875 or a dispensing chemist and druggist registered under the Pharmacy Act 1951 shall be construed as a reference to a registered pharmacist.

(2) Any reference (however expressed) in a prior enactment to a person who is keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts 1875 to 1977—

(a) where that person is, in relation to a pharmacist, a representative within the meaning given by section 25 (2), shall be construed as a reference to such a representative, and

(b) in any other case, shall be construed as a reference to a registered retail pharmacy business.

...

C15

Application of Act extended (15.06.2000) by Customs-Free Airport (Extension of Laws) Regulations 2000 (S.I. No. 169 of 2000), reg. 3.

3. The provisions of the Irish Medicines Board Act 1995 (No 29 of 1995), together with any Regulations made under Section 32 thereof and any other Regulations in force for the time being by virtue of Section 34(4) of the said Act, are hereby extended to the Customs-free Airport at Shannon.

Editorial Notes:

E34

Power pursuant to section exercised (31.10.2024) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2024 (S.I. No. 582 of 2024), in effect as per reg. 2.

E35

Power pursuant to section exercised (16.09.2024) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2024 (S.I. No. 458 of 2024), in effect as per reg. 2.

E36

Power pursuant to section exercised (22.04.2024) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2024 (S.I. No. 162 of 2024).

E37

Power pursuant to section exercised (1.03.2024) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2024 (S.I. No. 73 of 2024), in effect as per reg. 2.

E38

Power pursuant to section exercised (1.03.2024) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2024 (S.I. No. 72 of 2024), in effect as per reg. 2.

E39

Power pursuant to section exercised (21.12.2023) by Health Products Regulatory Authority (Fees) Regulations 2023 (S.I. No. 697 of 2023).

E40

Power pursuant to section exercised (29.11.2023) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2023 (S.I. No. 584 of 2023).

E41

Power pursuant to section exercised (14.09.2023) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023 (S.I. No. 451 of 2023).

E42

Power pursuant to section exercised (23.08.2023) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2023 (S.I. No. 422 of 2023).

E43

Power pursuant to section exercised (1.06.2023) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2023 (S.I. No. 284 of 2023).

E44

Power pursuant to section exercised (16.05.2023) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2023 (S.I. No. 238 of 2023).

E45

Power pursuant to section exercised (7.03.2023) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023 (S.I. No. 105 of 2023).

E46

Power pursuant to section exercised (23.01.2023) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2023 (S.I. No. 11 of 2023).

E47

Power pursuant to section exercised (20.09.2022) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2022 (S.I. No. 467 of 2022).

E48

Power pursuant to section exercised (29.07.2022) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2022 (S.I. No. 402 of 2022).

E49

Power pursuant to section exercised (14.07.2022) by In Vitro Diagnostic Medical Devices (Registration) Regulations 2022 (S.I. No. 365 of 2022).

E50

Power pursuant to section exercised (1.06.2022) by Medicinal Products (Safety Features on Packaging) Regulations 2022 (S.I. No. 270 of 2022).

E51

Power pursuant to section exercised (26.05.2022) by In Vitro Diagnostic Medical Devices Regulations 2022 (S.I. No. 256 of 2022), in effect as per reg. 2.

E52

Power pursuant to section exercised (24.02.2022) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2022 (S.I. No. 84 of 2022).

E53

Power pursuant to section exercised (15.02.2022) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2022 (S.I. No. 57 of 2022).

E54

Power pursuant to section exercised (31.01.2022) by Medicinal Products (Control of Manufacture) (Amendment) Regulations 2022 (S.I. No. 43 of 2022).

E55

Power pursuant to section exercised (1.01.2022, deemed) by Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2022 (S.I. No. 416 of 2022).

E56

Power pursuant to section exercised (1.01.2022, deemed) by Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2022 (S.I. No. 415 of 2022).

E57

Power pursuant to section exercised (1.01.2022, deemed) by Medicinal Products (Control of Manufacture) (Amendment) (No. 2) Regulations 2022 (S.I. No. 414 of 2022).

E58

Power pursuant to section exercised (25.01.2022) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2022 (S.I. No. 32 of 2022).

E59

Power pursuant to section exercised (16.12.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 15) Regulations 2021 (S.I. No. 718 of 2021).

E60

Power pursuant to section exercised (9.12.2021) by Medicinal Products (Prescription and Control of Supply (Amendment) (No. 14) Regulations 2021 (S.I. No. 692 of 2021).

E61

Power pursuant to section exercised (9.12.2021) by Medical Devices (Registration) Regulations 2021 (S.I. No. 691 of 2021).

E62

Power pursuant to section exercised (19.11.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 13) Regulations 2021 (S.I. No. 605 of 2021).

E63

Power pursuant to section exercised (5.11.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 12) Regulations 2021 (S.I. No. 578 of 2021).

E64

Power pursuant to section exercised (27.10.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 11) Regulations 2021 (S.I. No. 558 of 2021).

E65

Power pursuant to section exercised (7.10.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 10) Regulations 2021 (S.I. No. 511 of 2021).

E66

Power pursuant to section exercised (7.10.2021) by Medical Devices (Amendment) Regulations 2021 (S.I. No. 510 of 2021).

E67

Power pursuant to section exercised (28.09.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 9) Regulations 2021 (S.I. No. 492 of 2021).

E68

Power pursuant to section exercised (30.07.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) No. 8 Regulations 2021 (S.I. No. 411 of 2021).

E69

Power pursuant to section exercised (26.05.2021) by Medical Devices Regulations 2021 (S.I. No. 261 of 2021).

E70

Power pursuant to section exercised (13.05.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2021 (S.I. No. 245 of 2021).

E71

Power pursuant to section exercised (31.03.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2021 (S.I. No. 155 of 2021).

E72

Power pursuant to section exercised (23.03.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2021 (S.I. No. 130 of 2021).

E73

Power pursuant to section exercised (23.02.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2021 (S.I. No. 81 of 2021).

E74

Power pursuant to section exercised (4.02.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2021 (S.I. No. 43 of 2021).

E75

Power pursuant to section exercised (13.01.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2021 (S.I. No. 8 of 2021).

E76

Power pursuant to section exercised (4.01.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2021 (S.I. No. 2 of 2021).

E77

Power pursuant to section exercised (4.01.2021) by Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2021 (S.I. No. 1 of 2021).

E78

Power pursuant to section exercised (1.01.2021) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2020 (S.I. No. 614 of 2020), in effect as per reg. 2.

E79

Power pursuant to section exercised (24.12.2020) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2020 (S.I. No. 698 of 2020).

E80

Power pursuant to section exercised (30.09.2020) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2020 (S.I. No. 401 of 2020).

E81

Power pursuant to section exercised (3.07.2020) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2020 (S.I. No. 241 of 2020).

E82

Power pursuant to section exercised (4.06.2020) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2020 (S.I. No. 204 of 2020).

E83

Power pursuant to section exercised (15.05.2020) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2020 (S.I. No. 177 of 2020).

E84

Power pursuant to section exercised (2.04.2020) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020 (S.I. No. 98 of 2020).

E85

Power pursuant to section exercised (15.05.2019) by Medicinal Products (Control of Manufacture) (Amendment) Regulations 2019 (S.I. No. 219 of 2019).

E86

Power pursuant to section exercised (15.05.2019) by Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2019 (S.I. No. 218 of 2019).

E87

Power pursuant to section exercised (15.05.2019) by Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2019 (S.I. No. 217 of 2019).

E88

Power pursuant to section exercised (9.02.2019) by Medicinal Products (Safety Features On Packaging) Regulations 2019 (S.I. No. 36 of 2019).

E89

Power pursuant to section exercised (11.12.2018) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2018 (S.I. No. 530 of 2018).

E90

Power pursuant to section exercised (11.12.2018) by Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2018 (S.I. No. 529 of 2018).

E91

Power pursuant to section exercised (15.10.2015) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015 (S.I. No. 449 of 2015).

E92

Power pursuant to section exercised (24.06.2015) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015 (S.I. No. 87 of 2015).

E93

Power pursuant to section exercised (5.11.2014) by Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2014 (S.I. No. 504 of 2014).

E94

Power pursuant to section exercised (2.07.2014) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2014 (S.I. No. 300 of 2014).

E95

Power pursuant to section exercised (26.03.2014) by Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2014 (S.I. No. 151 of 2014).

E96

Power pursuant to section exercised (22.05.2013) by Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 (S.I. No. 164 of 2013).

E97

Power pursuant to section exercised (22.05.2013) by Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 (S.I. No. 163 of 2013).

E98

Power pursuant to section exercised (22.05.2013) by Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (S.I. No. 162 of 2013).

E99

Power pursuant to section exercised (25.07.2012) by Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 (S.I. No. 274 of 2012).

E100

Power pursuant to section501 exercised (25.07.2012) by Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012 (S.I. No. 273 of 2012).

E101

Power pursuant to section exercised (25.07.2012) by Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 (S.I. No. 272 of 2012).

E102

Power pursuant to section exercised (22.12.2011) by Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2011 (S.I. No. 722 of 2011).

E103

Power pursuant to section exercised (14.10.2011) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 (S.I. No. 525 of 2011).

E104

Power pursuant to section exercised (11.06.2010) by Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2010 (S.I. No. 288 of 2010), in effect as per reg. 3.

E105

Power pursuant to section exercised (11.06.2010) by Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2010 (S.I. No. 287 of 2010), in effect as per reg. 3.

E106

Power pursuant to section exercised (11.06.2010) by Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2010. (S.I. No. 286 of 2010), in effect as per reg. 3.

E107

Power pursuant to section exercised (1.01.2010) by Medicinal Products (Control of Placing On the Market) Regulations 2007 (Amendment) (No. 2) Regulations 2009 (S.I. No. 553 of 2009), in effect as per reg. 6.

E108

Power pursuant to section exercised (6.11.2009) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009 (S.I. No. 442 of 2009).

E109

Power pursuant to section exercised (14.01.2009) by Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2009 (S.I. No. 4 of 2009), in effect as per reg. 3.

E110

Power pursuant to section exercised (14.01.2009) by Medicinal Products (Control of Placing On the Market) Regulations 2007 (Amendment) Regulations 2009 (S.I. No. 3 of 2009), in effect as per reg. 3.

E111

Power pursuant to section exercised (14.01.2009) byMedicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2009 (S.I. No. 2 of 2009), in effect as per reg. 3.

E112

Power pursuant to section exercised (1.12.2008) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008 (S.I. No. 512 of 2008), in effect as per reg. 2(1).

E113

Power pursuant to section exercised (23.07.2007) by Medicinal Products (Control of Advertising) Regulations 2007 (S.I. No. 541 of 2007), in effect as per reg. 2.

E114

Power pursuant to section exercised (23.07.2007) by Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007), in effect as per reg. 2.

E115

Power pursuant to section exercised (23.07.2007) by Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007), in effect as per reg. 2.

E116

Power pursuant to section exercised (23.07.2007) by Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007), in effect as per reg. 2.

E117

Power pursuant to section exercised (1.05.2007) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 (S.I. No. 201 of 2007).

E118

Power pursuant to section exercised (1.04.2007) by Medicinal Products (Revocation of the Medical Preparations (Control of Amphetamine) Regulations 1969) Regulations 2007 (S.I. No. 99 of 2007), in effect as per reg. 2.

E119

Power pursuant to section exercised (9.08.2005) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 (S.I. No. 510 of 2005).

E120

Power pursuant to section exercised (18.10.2004) by Medicinal Products (Amendment) Regulations 2004 (S.I. No. 663 of 2004).

E121

Power pursuant to section exercised (11.11.2003) by Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), in effect as per reg. 2.

E122

Power pursuant to section exercised (14.11.2001) by Medicinal Products (Licensing and Sale) (Amendment) Regulations 2001 (S.I. No. 512 of 2001).

E123

Power pursuant to section exercised (17.06.1999) by Medicinal Products (Amendment) Regulations 1999 (S.I. No. 188 of 1999).

E124

Power pursuant to section exercised (17.06.1999) by Medical Preparations (Labelling and Package Leaflets) (Amendment) Regulations 1999 (S.I. No. 187 of 1999).

E125

Power pursuant to section exercised (19.02.1996) by Medical Preparations (Wholesale Licences) (Amendment) Regulations 1996 (S.I. No. 41 of 1996), in effect as per reg. 5.

E126

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.

E127

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.

E128

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.

E129

Previous affecting 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.

E130

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.

E131

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.

E132

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.

E133

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.

E134

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.

E135

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.

E136

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.

E137

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.

E138

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.

E139

Previous affecting provision: power pursuant to section exercised (1.07.2012) by European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2012 (S.I. No. 207 of 2012); revoked (26.05.2022) by In Vitro Diagnostic Medical Devices Regulations 2022 (S.I. No. 256 of 2022), reg. 37(c).

E140

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.

E141

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.

E142

Previously affecting provision: power pursuant to section exercised (1.01.2010) by Irish Medicines Board (Fees) Regulations 2009 (S.I. No. 551 of 2009); revoked (22.12.2010) by Irish Medicines Board (Fees) Regulations 2010 (S.I. No. 632 of 2010), reg. 5.

E143

Previously affecting provision: power pursuant to section exercised (1.01.2009) by Irish Medicines Board (Fees) Regulations 2008 (S.I. No. 542 of 2008); revoked (1.01.2010) by Irish Medicines Board (Fees) Regulations 2009 (S.I. No. 551 of 2009), reg. 7.

E144

Previous affecting provision: power pursuant to section exercised (1.01.2008) by Irish Medicines Board (Fees) Regulations 2007 (S.I. No. 866 of 2007), in effect as per reg. 2; revoked (1.01.2009) by Irish Medicines Board (Fees) Regulations 2008 (S.I. No. 542 of 2008), reg. 7, in effect as per reg. 2.

E145

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, in effect as per reg. 2.

E146

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.

E147

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.

E148

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.

E149

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.

E150

Previous affecting provision: power pursuant to section exercised (18.12.2002) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2002 (S.I. No. 627 of 2002), in effect as per reg. 3; revoked (11.11.2003) by Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), reg. 3, in effect as per reg. 2.

E151

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.

E152

Previous affecting provision: power pursuant to section exercised (1.10.2001) by Medicinal Products (Control of Paracetamol) Regulations 2001 (S.I. No. 150 of 2001), in effect as per reg. 2; revoked (11.11.2003) by Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), reg. 3, in effect as per reg. 2.

E153

Previous affecting provision: power pursuant to section exercised (3.05.2000) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2000 (S.I. No. 116 of 2000); revoked (11.11.2003) by Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), reg. 3, in effect as per reg. 2.

E154

Previous affecting provision: power pursuant to section exercised (1.09.1999) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 1999 (S.I. No. 271 of 1999), in effect as per reg. 3(1); revoked (11.11.2003) by Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), reg. 3, in effect as per reg. 2.

E155

Previous affecting provision: power pursuant to section exercised (6.05.1998) by Medicinal Products (Licensing and Sale) Regulations 1998 (S.I. No. 142 of 1998); revoked (23.07.2007) by Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007), reg. 26(1), in effect as per reg. 2.

E156

Previous affecting provision: power pursuant to section exercised (15.10.1996) by Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 1996 (S.I. No. 309 of 1996); revoked (11.11.2003) by Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), reg. 3, in effect as per reg. 2.

E157

Previous affecting provision: power pursuant to section exercised (15.10.1996) by Medical Preparations (Advertising) (Amendment) Regulations 1996 (S.I. No. 308 of 1996); revoked (23.07.2007) by Medicinal Products (Control of Advertising) Regulations 2007 (S.I. No. 541 of 2007), reg. 3, in effect as per reg. 2.

E158

Previous affecting provision: power pursuant to section exercised (1.09.1996) by Medicinal Products (Prescription and Control of Supply) Regulations 1996 (S.I. No. 256 of 1996), in effect as per reg. 2; revoked (11.11.2003) by Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), reg. 3, in effect as per reg. 2.

E159

Previous affecting provision: power pursuant to section exercised (19.02.1996) by Medical Preparations (Licensing and Sale) Regulations 1996 (S.I. No. 43 of 1996), in effect as per reg. 16; revoked (6.05.1998) by Medicinal Products (Licensing and Sale) Regulations 1998 (S.I. No. 142 of 1998), reg. 15.

E160

Previous affecting provision: power pursuant to section exercised (19.02.1996) by Medical Preparations (Licensing of Manufacture) (Amendment) Regulations 1996 (S.I. No. 42 of 1996), in effect as per reg. 5; revoked (23.07.2007) by Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007), reg. 16, in effect as per reg. 2.

Revised Acts

Latest News and Publications

Irish Medicines Board Act 1995