Irish Medicines Board Act 1995


Number 29 of 1995


IRISH MEDICINES BOARD ACT 1995

REVISED

Updated to 14 September 2023


This Revised Act is an administrative consolidation of the Irish Medicines Board Act 1995. It is prepared by the Law Reform Commission in accordance with its function under the Law Reform Commission Act 1975 (3/1975) to keep the law under review and to undertake revision and consolidation of statute law.

All Acts up to and including the Historic and Archaeological Heritage and Miscellaneous Provisions Act 2023 (26/2023), enacted 13 October 2023, and all statutory instruments up to and including the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023 (S.I. No. 451 of 2023), made 14 September 2023, were considered in the preparation of this Revised Act.

Disclaimer: While every care has been taken in the preparation of this Revised Act, the Law Reform Commission can assume no responsibility for and give no guarantees, undertakings or warranties concerning the accuracy, completeness or up to date nature of the information provided and does not accept any liability whatsoever arising from any errors or omissions. Please notify any errors, omissions and comments by email to

revisedacts@lawreform.ie.


Number 29 of 1995


IRISH MEDICINES BOARD ACT 1995

REVISED

Updated to 14 September 2023


Introduction

This Revised Act presents the text of the Act as it has been amended since enactment, and preserves the format in which it was passed.

Related legislation

Irish Medicines Board Acts 1995 and 2006: this Act is one of a group of Acts included in this collective citation, to be construed together as one (Irish Medicines Board (Miscellaneous Provisions) Act 2006, s. 1(3)). The Acts in the group are:

Irish Medicines Board Act 1995 (29/1995)

Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), Part 3 (ss. 10-20)

Annotations

This Revised Act is annotated and includes textual and non-textual amendments, statutory instruments made pursuant to the Act and previous affecting provisions.

An explanation of how to read annotations is available at

www.lawreform.ie/annotations.

Material not updated in this revision

Where other legislation is amended by this Act, those amendments may have been superseded by other amendments in other legislation, or the amended legislation may have been repealed or revoked. This information is not represented in this revision but will be reflected in a revision of the amended legislation if one is available.

Where legislation or a fragment of legislation is referred to in annotations, changes to this legislation or fragment may not be reflected in this revision but will be reflected in a revision of the legislation referred to if one is available.

A list of legislative changes to any Act, and to statutory instruments from 1972, may be found linked from the page of the Act or statutory instrument at

www.irishstatutebook.ie.

Acts which affect or previously affected this revision

Data Protection Act 2018 (7/2018)

Health (Miscellaneous Provisions) Act 2017 (1/2017)

Freedom of Information Act 2014 (30/2014)

Health (Pricing and Supply of Medical Goods) Act 2013 (14/2013)

Ministers and Secretaries (Amendment) Act 2011 (10/2011)

Fines Act 2010 (8/2010)

Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006)

Health Act 2004 (42/2004)

Finance Act 1999 (2/1999)

Freedom of Information Act 1997 (13/1997)

All Acts up to and including Historic and Archaeological Heritage and Miscellaneous Provisions Act 2023 (26/2023), enacted 13 October 2023, were considered in the preparation of this revision.

Statutory instruments which affect or previously affected this revision

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023 (S.I. No. 451 of 2023)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2023 (S.I. No. 422 of 2023)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2023 (S.I. No. 284 of 2023)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2023 (S.I. No. 238 of 2023)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023 (S.I. No. 105 of 2023)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2023 (S.I. No. 11 of 2023)

Health Products Regulatory Authority (Fees) Regulations 2022 (S.I. No. 679 of 2022)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2022 (S.I. No. 467 of 2022)

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2022 (S.I. No. 416 of 2022)

Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2022 (S.I. No. 415 of 2022)

Medicinal Products (Control of Manufacture) (Amendment) (No. 2) Regulations 2022 (S.I. No. 414 of 2022)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2022 (S.I. No. 402 of 2022)

In Vitro Diagnostic Medical Devices (Registration) Regulations 2022 (S.I. No. 365 of 2022)

Medicinal Products (Safety Features on Packaging) Regulations 2022 (S.I. No. 270 of 2022)

In Vitro Diagnostic Medical Devices Regulations 2022 (S.I. No. 256 of 2022)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2022 (S.I. No. 84 of 2022)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2022 (S.I. No. 57 of 2022)

Medicinal Products (Control of Manufacture) (Amendment) Regulations 2022 (S.I. No. 43 of 2022)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2022 (S.I. No. 32 of 2022)

Health Products Regulatory Authority (Fees) Regulations 2021 (S.I. No. 744 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 15) Regulations 2021 (S.I. No. 718 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 14) Regulations 2021 (S.I. No. 692 of 2021)

Medical Devices (Registration) Regulations 2021 (S.I. No. 691 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 13) Regulations 2021 (S.I. No. 605 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 12) Regulations 2021 (S.I. No. 578 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 11) Regulations 2021 (S.I. No. 558 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 10) Regulations 2021 (S.I. No. 511 of 2021)

Medical Devices (Amendment) Regulations 2021 (S.I. No. 510 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 9) Regulations 2021 (S.I. No. 492 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) No. 8 Regulations 2021 (S.I. No. 411 of 2021)

Medical Devices Regulations 2021 (S.I. No. 261 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2021 (S.I. No. 245 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No.6) Regulations 2021 (S.I. No. 155 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2021 (S.I. No. 130 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No.4) Regulations 2021 (S.I. No. 81 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2021 (S.I. No. 43 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2021 (S.I. No. 8 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2021 (S.I. No. 2 of 2021)

Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2021 (S.I. No. 1 of 2021)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2020 (S.I. No. 698 of 2020)

Health Products Regulatory Authority (Fees) Regulations 2020 (S.I. No. 654 of 2020)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2020 (S.I. No. 614 of 2020)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2020 (S.I. No. 401 of 2020)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2020 (S.I. No. 241 of 2020)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2020 (S.I. No. 204 of 2020)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2020 (S.I. No. 177 of 2020)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020 (S.I. No. 98 of 2020)

Health Products Regulatory Authority (Fees) Regulations 2019 (S.I. No. 700 of 2019)

Medicinal Products (Control of Manufacture) (Amendment) Regulations 2019 (S.I. No. 219 of 2019)

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2019 (S.I. No. 218 of 2019)

Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2019 (S.I. No. 217 of 2019)

Medicinal Products (Safety Features On Packaging) Regulations 2019 (S.I. No. 36 of 2019)

Health Products Regulatory Authority (Fees) (No. 2) Regulations 2018 (S.I. No. 531 of 2018)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2018 (S.I. No. 530 of 2018)

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2018 (S.I. No. 529 of 2018)

Health Products Regulatory Authority (Fees) Regulations 2018 (S.I. No. 208 of 2018)

Health Products Regulatory Authority (Fees) Regulations 2017 (S.I. No. 557 of 2017)

European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (S.I. No. 547 of 2017)

Health Products Regulatory Authority (Fees) Regulations 2016 (S.I. No. 602 of 2016)

Health Products Regulatory Authority (Fees) Regulations 2015 (S.I. No. 599 of 2015)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015 (S.I. No. 449 of 2015)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015 (S.I. No. 87 of 2015)

Health Products Regulatory Authority (Fees) Regulations 2014 (S.I. No. 607 of 2014)

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2014 (S.I. No. 504 of 2014)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2014 (S.I. No. 300 of 2014)

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2014 (S.I. No. 151 of 2014)

Irish Medicines Board (Fees) Regulations 2013 (S.I. No. 510 of 2013)

Irish Medicines Board (Fees) (Amendment) Regulations 2013 (S.I. No. 165 of 2013)

Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 (S.I. No. 164 of 2013)

Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 (S.I. No. 163 of 2013)

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (S.I. No. 162 of 2013)

Irish Medicines Board (Fees) Regulations 2012 (S.I. No. 572 of 2012)

Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 (S.I. No. 274 of 2012)

Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012 (S.I. No. 273 of 2012)

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 (S.I. No. 272 of 2012)

European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2012 (S.I. No. 207 of 2012)

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2011 (S.I. No. 722 of 2011)

Irish Medicines Board (Fees) Regulations 2011 (S.I. No. 684 of 2011)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 (S.I. No. 525 of 2011)

Finance (Transfer of Departmental Administration and Ministerial Functions) Order 2011 (S.I. No. 418 of 2011)

Irish Medicines Board (Fees) Regulations 2010 (S.I. No. 632 of 2010)

Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2010 (S.I. No. 288 of 2010)

Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2010 (S.I. No. 287 of 2010)

Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2010 (S.I. No. 286 of 2010)

Medicinal Products (Control of Placing On the Market) Regulations 2007 (Amendment) (No. 2) Regulations 2009 (S.I. No. 553 of 2009)

Irish Medicines Board (Fees) Regulations 2009 (S.I. No. 551 of 2009)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009 (S.I. No. 442 of 2009)

Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2009 (S.I. No. 4 of 2009)

Medicinal Products (Control of Placing On the Market) Regulations 2007 (Amendment) Regulations 2009 (S.I. No. 3 of 2009)

Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2009 (S.I. No. 2 of 2009)

Irish Medicines Board (Fees) Regulations 2008 (S.I. No. 542 of 2008)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008 (S.I. No. 512 of 2008)

Irish Medicines Board (Fees) Regulations 2007 (S.I. No. 866 of 2007)

European Communities (Amendment of the Irish Medicines Board Act 1995) Regulations 2007 (S.I. No. 542 of 2007)

Medicinal Products (Control of Advertising) Regulations 2007 (S.I. No. 541 of 2007)

Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007)

Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007)

Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007)

 Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 (S.I. No. 201 of 2007)

Medicinal Products (Revocation of the Medical Preparations (Control of Amphetamine) Regulations 1969) Regulations 2007 (S.I. No. 99 of 2007)

Irish Medicines Board (Fees) Regulations 2006 (S.I. No. 617 of 2006)

Irish Medicines Board (Fees) Regulations 2005 (S.I. No. 882 of 2005)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 (S.I. No. 510 of 2005)

Irish Medicines Board (Fees) Regulations 2004 (S.I. No. 877 of 2004)

Medicinal Products (Amendment) Regulations 2004 (S.I. No. 663 of 2004)

Irish Medicines Board (Fees) (Amendment) Regulations 2004 (S.I. No. 524 of 2004)

Irish Medicines Board (Fees) Regulations 2003 (S.I. No. 731 of 2003)

Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2002 (S.I. No. 627 of 2002)

European Communities (Medical Devices) (Amendment) Regulations 2002 (S.I. No. 576 of 2002)

Irish Medicines Board (Fees) (Medicinal Products For Human Use) Regulations 2002 (S.I. No. 262 of 2002)

Medicinal Products (Licensing and Sale) (Amendment) Regulations 2001 (S.I. No. 512 of 2001)

European Communities (Medical Devices) (Amendment) Regulations 2001 (S.I. No. 444 of 2001)

European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 (S.I. No. 304 of 2001)

Medicinal Products (Control of Paracetamol) Regulations 2001 (S.I. No. 150 of 2001)

Irish Medicines Board (Fees) (Amendment) Regulations 2000 (S.I. No. 233 of 2000)

Customs-Free Airport (Extension of Laws) Regulations 2000 (S.I. No. 169 of 2000)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2000 (S.I. No. 116 of 2000)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 1999 (S.I. No. 271 of 1999)

Medicinal Products (Amendment) Regulations 1999 (S.I. No. 188 of 1999)

Medical Preparations (Labelling and Package Leaflets) (Amendment) Regulations 1999 (S.I. No. 187 of 1999)

Irish Medicines Board (Competent Authority) Order 1998 (S.I. No. 143 of 1998)

Medicinal Products (Licensing and Sale) Regulations 1998 (S.I. No. 142 of 1998)

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 1996 (S.I. No. 309 of 1996)

Medical Preparations (Advertising) (Amendment) Regulations 1996 (S.I. No. 308 of 1996)

Medicinal Products (Prescription and Control of Supply) Regulations 1996 (S.I. No. 256 of 1996)

Irish Medicines Board (Fees) Regulations 1996 (S.I. No. 44 of 1996)

Medical Preparations (Licensing and Sale) Regulations 1996 (S.I. No. 43 of 1996)

Medical Preparations (Licensing of Manufacture) (Amendment) Regulations 1996 (S.I. No. 42 of 1996)

Medical Preparations (Wholesale Licences) (Amendment) Regulations 1996 (S.I. No. 41 of 1996)

Irish Medicines Board Act 1995 (Commencement) Order 1996 (S.I. No. 40 of 1996)

Irish Medicines Board Act 1995 (Establishment) Order 1995 (S.I. No. 346 of 1995)

Irish Medicines Board Act 1995 (Commencement) Order 1995 (S.I. No. 345 of 1995)

All statutory instruments up to and including Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023 (S.I. No. 451 of 2023), made 14 September 2023, were considered in the preparation of this revision.


Number 29 of 1995


IRISH MEDICINES BOARD ACT 1995

REVISED

Updated to 14 September 2023


ARRANGEMENT OF SECTIONS

Section

1.

Interpretation.

2.

Establishment day.

3.

Establishment of Irish Medicines Board.

4.

Functions of Board.

5.

Conferral of additional functions on Board.

6.

Chairperson of Board.

7.

Members of Board.

7A.

Remuneration and allowances for expenses of members of Health Products Regulatory Authority.

8.

Meetings of Board.

9.

Advisory committees.

10.

Chief Executive.

11.

Staff of Board.

12.

Superannuation of staff of Board.

13.

Fees.

14.

Charges for services.

15.

Grants to Board.

16.

Gifts.

17.

Borrowing by Board.

18.

Accounts and audits of Board.

19.

Reports and information to Minister.

20.

Assessment by Board of performance of certain of its functions.

21.

General duty of Board.

22.

Membership of either House of Oireachtas or of European Parliament.

23.

Disclosure of information.

24.

Disclosure of interests.

25.

Dissolution of former Board.

26.

Transfer of assets and liabilities of former Board.

27.

Preservation of certain continuing contracts and adaptation of references to former Board.

28.

Saving for certain acts.

29.

Pending legal proceedings.

30.

Exemption from stamp duty. (Repealed)

31.

Completion of certain matters commenced by Minister or by former Board.

32.

Regulations.

32A.

Interpretation of sections 32A to 32F inclusive.

32B.

Authorised officers.

32C.

Taking of samples, etc., by authorised officers.

32D.

Certificate of result of test, etc., of sample, etc.

32E.

Penalties for offences.

32F.

Proceedings.

33.

Offences by bodies corporate.

34.

Repeal and transitional provisions.

35.

Amendment of enactments.

36.

Expenses.

37.

Laying of orders and regulations before Houses of Oireachtas.

38.

Short title and commencement.

SCHEDULE

Amendment of Enactments


Number 29 of 1995


IRISH MEDICINES BOARD ACT 1995

REVISED

Updated to 14 September 2023


AN ACT TO MAKE FURTHER PROVISION IN RELATION TO THE REGULATION OF THE MANUFACTURE, PRODUCTION, PREPARATION, IMPORTATION, ADVERTISEMENT, SALE AND DISTRIBUTION OF MEDICINAL AND COSMETIC PRODUCTS, FOR THOSE AND OTHER PURPOSES TO PROVIDE FOR THE ESTABLISHMENT OF A BOARD TO BE KNOWN AS THE IRISH MEDICINES BOARD, TO PROVIDE FOR THE DISSOLUTION OF THE NATIONAL DRUGS ADVISORY BOARD AND THE CONFERRAL OF ITS FUNCTIONS ON THE IRISH MEDICINES BOARD AND TO PROVIDE FOR RELATED MATTERS. [15th November, 1995]

BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS:

Annotations:

Modifications (not altering text):

C1

Functions in relation to Act transferred to Health Service Executive (1.01.2005) by Health Act 2004 (42/2004), ss. 58, 59 and sch. 3, S.I. No. 887 of 2004.

Dissolution of health boards and other specified bodies.

58.—The specified bodies are, by this Act, dissolved on the establishment day.

Transfer of functions of specified bodies to Executive.

59.—(1) The functions that, immediately before the establishment day, were the functions of a specified body under or in connection with the enactments referred to in Schedule 3 are, by this Act, transferred to the Executive on that day.

(2) If a provision of an enactment referred to in Schedule 3, or a provision of an instrument made under such enactment, does not come into effect until on or after the establishment day, a function that on the passing of that enactment or the making of that instrument was assigned under or in connection with that provision to a specified body is, by this Act, transferred to the Executive on the commencement of that provision.

(3) The functions transferred by this Act to the Executive include the functions specified in any enactment referred to in Schedule 3 as a function of the following:

(a) the chief executive officer of a health board;

(b) the Regional Chief Executive of the Eastern Regional Health Authority;

(c) the area chief executive of an Area Health Board.

...

SCHEDULE 3

Transfer of Functions and References to Functional Areas

Section 59 and 67

...

39. Irish Medicines Board Act 1995

...

C2

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.