Irish Medicines Board Act 1995

Number 29 of 1995

IRISH MEDICINES BOARD ACT 1995

REVISED

Updated to 31 October 2024

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 Criminal Justice (Hate Offences) Act 2024 (41/2024), enacted 29 October 2024, and all statutory instruments up to and including the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2024 (S.I. No. 582 of 2024), made 31 October 2024, made 31 October 2024, 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 31 October 2024


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.

32G.

Substitution by pharmacists in case of medicinal product shortage.

32H.

Regulations governing protocol.

32I.

Reporting of information to support the security of supply of medicines.

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 31 October 2024


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.