IE
(LRC Revised)
Statutory Text (1 Articles)
Number 29 of 1995
IRISH MEDICINES BOARD ACT 1995
REVISED
Updated to 17 December 2025
Changes to legislation
as of 10 July 2026, there are changes to this Act which have not been implemented by the Revised Acts editorial team, see highlighted entries
here
. Note that some amendments may not be in force until commenced by a commencement order or other provision.
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
Employment (Contractual Retirement Ages) Act 2025
(16/2025), enacted 16 December 2025, and all statutory instruments up to and
including the
Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations
2025
(S.I. No. 625 of 2025), made 17 December 2025, 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 17 December 2025
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 17 December 2025
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. [15
th 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.
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.
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