Irish Medicines Board (Miscellaneous Provisions) Act 2006

Irish Medicines Board (Miscellaneous Provisions) Act 2006 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.ie) Translations (Houses of the Oireachtas) Government Publications for Sale EU Law (EUR-Lex) FAQ Disclaimer Feedback Helpdesk Search Baile Reachtaíocht Achtanna an Oireachtais Ionstraimí Reachtúla Reachtaíocht Réamh-1922 Bunreacht Acmhainní Seachtracha Billí (Tithe an Oireachtais) Iris Oifigiúil Achtanna Athbhreithnithe (CAD) (An Coimisiún um Athchóiriú an Dlí) Liosta Rangaithe Reachtaíochta Aistriúcháin (achtanna.ie) Aistriúcháin (Tithe an Oireachtais) Foilseacháin Rialtais ar Díol Dlí AE (EUR-Lex) CCanna (Ceisteanna Coitianta) Séanadh Aiseolas Deasc chabhrach Cuardach TitleTeideal Year(s) or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile ActsAchtanna 2006 Irish Medicines Board (Miscellaneous Provisions) Act 2006 Irish Medicines Board (Miscellaneous Provisions) Act 2006 Permanent Page URL View by SectionAmharc de réir Ailt View Full ActAmharc ar an Acht Iomlán Bill History Stair Bille Commencement, Amendments, SIs made under the Act Tosach Feidhme, Leasuithe, IRí arna ndéanamh faoin Acht Open PDFOscail PDF Print Full ActPriontáil an tAcht Iomlán Number 3 of 2006 IRISH MEDICINES BOARD (MISCELLANEOUS PROVISIONS) ACT 2006 ARRANGEMENT OF SECTIONS

PART 1

Preliminary Section

Section 1

Section 2

PART 2

Amendment of Misuse of Drugs Act 1977

Section 3

Section 4

Section 5

Section 6

Section 7

Section 8

Section 9

PART 3

Amendment of Irish Medicines Board Act 1995

Section 10

Section 11

Section 12

Section 13

Section 14

Section 15

Section 16

Section 17

Section 18

Section 19

Section 20

PART 4

Amendment of Control of Clinical Trials Act 1987

Section 21

Section 22

Section 23

Section 24

PART 5

Amendment of Health Acts 1947 to 2005

Section 25

Section 26

Section 27

Section 28

Section 29

PART 6

Consequential Amendments to Regulations Made Under Section 32 of Irish Medicines Board Act 1995 or Referred to in Section 34(4) of that Act

Section 30

Section 31

Section 32

Section 33

Section 34

Section 35

Section 36

Section 37

Section 38

Section 39

Section 40

PART 7

Amendment of Animal Remedies Act 1993

Section 41

Acts Referred to Animal Remedies Act 1993 1993, No. 23 Companies Act 1963 1963, No. 33 Control of Clinical Trials Act 1987 1987, No. 28 Control of Clinical Trials Acts 1987 and 1990 Data Protection Acts 1988 and 2003 Dentists Act 1985 1985, No. 9 European Communities Act 1972 1972, No. 27 Health Act 1947 1947, No. 28 Health Act 1970 1970, No. 1 Health Acts 1947 to 2005 Health (Amendment) Act 1994 1994, No. 11 Irish Medicines Board Act 1995 1995, No. 29 Medical Practitioners Act 1978 1978, No. 4 Misuse of Drugs Act 1977 1977, No. 12 Misuse of Drugs Act 1984 1984, No. 18 Misuse of Drugs Acts 1977 and 1984 Nurses Act 1985 1985, No. 18 Petty Sessions (Ireland) Act 1851 14 & 15 Vic., c. 93 Pharmacy Acts 1875 to 1977 Sale of Food and Drugs Act 1875 38 & 39 Vic., c. 63 Trade Marks Act 1996 1996, No. 6 Number 3 of 2006 IRISH MEDICINES BOARD (MISCELLANEOUS PROVISIONS) ACT 2006 AN ACT TO AMEND THE MISUSE OF DRUGS ACT 1977 (AS AMENDED BY THE MISUSE OF DRUGS ACT 1984); TO AMEND THE IRISH MEDICINES BOARD ACT 1995; TO AMEND THE CONTROL OF CLINICAL TRIALS ACT 1987; TO AMEND THE HEALTH ACTS 1947 TO 2005; AND TO CONSEQUENTIALLY AMEND REGULATIONS THAT ARE EITHER MADE UNDER THE IRISH MEDICINES BOARD ACT 1995 OR REFERRED TO IN SECTION 34(4) OF THAT ACT AND TO AMEND THE ANIMAL REMEDIES ACT 1993. [4th March, 2006] BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS:

PART 1

Preliminary Short title, collective citation, construction and commencement.

1.— (1) This Act may be cited as the Irish Medicines Board (Miscellaneous Provisions) Act 2006.

Part 2

may be cited together as the Misuse of Drugs Acts 1977 to 2006 and shall be construed together as one.

Part 3

may be cited together as the Irish Medicines Board Acts 1995 and 2006 and shall be construed together as one.

Part 4

may be cited together as the Control of Clinical Trials Acts 1987 to 2006 and shall be construed together as one.

Part 5

may be cited together as the Health Acts 1947 to 2006 and shall be construed together as one.

Part 7

may be cited together as the Animal Remedies Acts 1993 and 2006.

Part 7

) shall come into operation on such day or days as the Minister for Health and Children may appoint by order or orders either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or provisions.

Interpretation.

2.— A reference in this Act to any enactment shall be construed as a reference to the enactment as amended, adapted or extended by or under any other enactment including this Act.

PART 2

Amendment of Misuse of Drugs Act 1977 Amendment of section 1 of Misuse of Drugs Act 1977 (interpretation).

3.—

Section 1

Amendment of section 5 of Misuse of Drugs Act 1977 (regulations to prevent misuse of controlled drugs).

4.—

Section 5

of the Misuse of Drugs Act 1977 is amended— (a) in subsection (1), by substituting the following for paragraph (f): “(f) subject to subsection (1A) of this section, regulating the issue by— (i) registered medical practitioners, registered dentists or registered veterinary surgeons, or (ii) registered nurses, or registered nurses belonging to a class of registered nurses, of prescriptions for controlled drugs and the supply of controlled drugs on prescription,”, (b) by inserting the following after subsection (1): “(1A) The Minister shall only exercise the power to make regulations under subsection (1)(f) of this section in the case of registered nurses, or registered nurses belonging to a class of registered nurses, if the Minister, after having had regard to the nature and purpose of the controlled drug concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the issue by registered nurses, or registered nurses belonging to a class of registered nurses, of prescriptions for that drug.”, (c) in subsection (2), in paragraph (a), by inserting “(other than a registered nurse)” after “practitioner”, and (d) by inserting the following after subsection (2): “(3) Subject to section 13 of this Act, the Minister may exercise the Minister's power to make regulations under this section so as to secure that it is not unlawful under this Act for a practitioner who is a registered nurse, or a practitioner who is a registered nurse belonging to a class of registered nurses, for the purpose of the practitioner's profession as a registered nurse, to prescribe, administer, manufacture, compound or supply a controlled drug if the Minister, after having had regard to the nature and purpose of the controlled drug (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the practitioner, for the purpose of the practitioner's profession as a registered nurse, to prescribe, administer, manufacture, compound or supply that controlled drug.”.

Amendment of section 6 of Misuse of Drugs Act 1977 (directions prohibiting prescribing, supply, etc., of controlled drugs by practitioners or pharmacists, etc., convicted of offences).

5.—

Section 6

of the Misuse of Drugs Act 1977 is amended— (a) by inserting the following after subsection (1): “(1A) Where a relevant person has after the commencement of this subsection been convicted of— (a) an offence under this Act, or (b) an offence against the Customs Acts in relation to the importation or exportation of a controlled drug, the Minister may give a direction under subsection (2) of this section in respect of that person.”, (b) in subsection (2)(b), by substituting “or relevant person, be a direction prohibiting the pharmacist or relevant person, as the case may be, from having in the pharmacist’s or relevant person’s, as the case may be,” for “, be a direction prohibiting him from having in his”, and (c) by inserting the following after subsection (6): “(7) In this section, ‘relevant person’ means— (a) a person, not being a pharmacist, keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the provisions of the Pharmacy Acts 1875 to 1977, or (b) any director, manager, secretary or other official of a person referred to in paragraph (a) of this definition which is a body corporate.”.

Amendment of section 8 of Misuse of Drugs Act 1977 (investigation of cases where Minister considers there are grounds for special direction).

6.—

Section 8

Amendment of section 14 of Misuse of Drugs Act 1977 (licences, etc.).

7.—

Section 14

of the Misuse of Drugs Act 1977 is amended— (a) in subsection (1), by substituting “Irish Medicines Board” for “Minister”, and (b) by inserting the following after subsection (2): “(3) A licence, permit or authorisation— (a) granted or issued by the Minister under subsection (1) (including granted or issued by way of being renewed) at any time before the commencement of this subsection, and (b) in force immediately before that commencement, shall, on and after that commencement but subject to the conditions, if any, attached under subsection (1) to it and in force immediately before that commencement, continue in force, unless sooner revoked under subsection (1), for the unexpired portion of the period of validity, if any, which it had left to run immediately before that commencement as if, on that commencement, the Irish Medicines Board had, under subsection (1)— (c) granted or issued that licence, permit or authorisation, and (d) attached to that licence, permit or authorisation those conditions, if any, and the provisions of this Act shall apply to the licence, permit or authorisation accordingly.”.

Amendment of section 17 of Misuse of Drugs Act 1977 (prohibition of cultivation of opium poppy or cannabis plant).

8.—

Section 17

of the Misuse of Drugs Act 1977 (as amended by section 11

Amendment of section 24 of Misuse of Drugs Act 1977 (powers to inspect and demand production of drugs, books or documents).

9.—

Section 24

of the Misuse of Drugs Act 1977 is amended— (a) in subsection (1)— (i) by substituting “writing in that behalf by the Minister or the Irish Medicines Board” for “that behalf by the Minister in writing”, (ii) in paragraph (a), by adding “or as a practitioner” after “drugs”, and (iii) in paragraph (c), by inserting “(including any data within the meaning of the Data Protection Acts 1988 and 2003)” after “documents”, and (b) by substituting the following for subsection (2): “(2) For the purposes of enforcing this Act and any statutory instruments made thereunder, and without prejudice to the generality of subsection (1) of this section, a person authorised in writing in that behalf by the Council of the Pharmaceutical Society of Ireland may at all reasonable times— (a) enter any building or premises in which a person keeps open shop for the dispensing or compounding of medical prescriptions, (b) require any such person, or any person employed in connection with keeping such open shop for the dispensing or compounding of medical prescriptions, to produce any controlled drugs which are in his possession or under his control, (c) require any such person, or any person so employed, to produce any books, records or other documents (including any data within the meaning of the Data Protection Acts 1988 and 2003) which relate to transactions concerning controlled drugs and which are in his possession or under his control, and (d) inspect any controlled drug, book, record or other document produced in pursuance of a requirement under this section.

PART 3

Amendment of Irish Medicines Board Act 1995 Amendment of section 1 of Irish Medicines Board Act 1995 (interpretation).

10.—

Section 1

Amendment of section 4 of Irish Medicines Board Act 1995 (functions of Board).

11.—

Section 4

of the Irish Medicines Board Act 1995 is amended— (a) in subsection (1)— (i) by substituting “Subject to subsection (4), the” for “The”; (ii) by substituting the following for paragraphs (b), (c) and (d): “(b) to exercise the powers conferred on the competent authority by Directive No. 2001/83/EC of 6 November 20015, (c) to exercise the powers conferred on the supervisory authority by Regulation (EC) No. 726/2004 of 31 March 2004 7 , (d) to exercise the powers conferred on the competent authority by Directive No. 2001/82/EC of 6 November 20016,”; (iii) by substituting the following for paragraph (k): “(k) to establish and administer a service— (i) for the receipt of applications from persons proposing to export any description of medicinal products, cosmetic products, veterinary medicinal products or medical devices, and (ii) for the issue to such persons of certificates containing any statement relating to such description of such products or devices as the Board considers appropriate after having regard to— (I) the law (whether under any enactment or rule of law or otherwise) in the State which is for the time being applicable to such description of such products or devices, and (II) the law (whether under any enactment or rule of law or otherwise) in the place to which such description of such products or devices is to be exported which is for the time being applicable to such description of such products or devices,”; (iv) in paragraph (p), by substituting “1994),” for “1994).”; and (v) by inserting the following after paragraph (p): “(q) to exercise, subject to subsection (5), the powers specified in section 14

Amendment of section 5 of Irish Medicines Board Act 1995 (conferral of additional functions on Board).

12.—

Section 5

Amendment of section 7 of Irish Medicines Board Act 1995 (members of Board).

13.—

Section 7

of the Irish Medicines Board Act 1995 is amended by substituting the following for subsection (9): “(9) Of the members of the Board— (a) one shall be the chairperson of the Advisory Committee for Human Medicines, (b) one shall be the chairperson of the Advisory Committee for Veterinary Medicines, and (c) one shall be the chairperson of the Advisory Committee for Medical Devices, but no member shall be the chairperson of more than one of those committees.”.

Amendment of section 9 of Irish Medicines Board Act 1995 (advisory committees).

14.—

Section 9

of the Irish Medicines Board Act 1995 is amended— (a) by substituting the following for subsections (8) and (9): “(8) The Board shall not refuse to grant a licence or authorisation in respect of— (a) a medicinal product or class of medicinal products, or (b) the manufacture or wholesale of a medicinal product or class of medicinal products, on any ground relating to the safety, quality or efficacy of the medicinal product or class of medicinal products, as the case may be, unless the Board has requested the advice of the appropriate committee in relation thereto and considered the advice given pursuant to the request.

Amendment of section 13 of Irish Medicines Board Act 1995 (fees).

15.—

Section 13

of the Irish Medicines Board Act 1995 is amended— (a) by substituting the following for subsection (1): “(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.”; (b) in subsection (2), by substituting “matter or application, the matter or application” for “application or matter, the application or matter”; and (c) by inserting the following after subsection (4): “(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.

Amendment of section 32 of Irish Medicines Board Act 1995 (regulations).

16.—

Section 32

of the Irish Medicines Board Act 1995 is amended— (a) in subsection (2)— (i) by substituting “, cosmetic products or medical devices” for “or cosmetic products”, (ii) in paragraph (a)— (I) by inserting “administration,” after “supply,”, and (II) by inserting “, or the device or devices,” after “the product or products”, (iii) in paragraph (b)— (I) by inserting “, or the device or devices,” after “the product or products”, and (II) by inserting “or such device or devices” after “such product or products”, (iv) in paragraph (c)— (I) by inserting “, or the device or devices,” after “the product or products”, (II) by substituting “, authorisation or certificate for such product or products or such device or devices” for “for the advertisement of such products”, and (III) by substituting “or products or such device or devices which is or are” for “which is”, (v) in paragraph (d)— (I) by inserting “, or the device or devices,” after “the product or products”, (II) by inserting “, or such device or devices,” after “such product or products” where it twice appears, (vi) in paragraphs (e), (f) and (g), by inserting “, authorisations or certificates” after “licences”, (vii) in paragraph (h)— (I) by inserting “, authorisation or certificates” after “of licences”, (II) by inserting “, or the device or devices,” after “products”, (III) by inserting “, authorisations or certificates” after “or licences”, (viii) by substituting the following for paragraphs (i), (j), (k), (l) and (m): “(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, or (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 2001 12 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

Insertion of new sections 32A to 32F into Irish Medicines Board Act 1995 (authorised officers, etc.).

17.— The Irish Medicines Board Act 1995 is amended by inserting the following after section 32: “Interpretation of sections 32A to 32F inclusive.

32A.— In this section and sections 32B to 32F inclusive— ‘ authorised officer ’ means— (a) a person appointed under section 32B(1) to be an authorised officer, or (b) an officer of customs and excise; ‘ inspect ’ includes search; ‘ premises ’ means any place, ship or other vessel, aircraft, railway wagon or other vehicle, and includes a container used to transport relevant things; ‘ record ’ includes, in addition to a record in writing— (a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form, (b) a film, tape or other device in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and (c) a photograph, and any reference to a copy of a record includes— (d) in the case of a record to which paragraph (a) applies, a transcript of the sounds or signals embodied therein, (e) in the case of a record to which paragraph (b) applies, a still reproduction of the images embodied therein, and (f) in the case of a record to which paragraphs (a) and (b) apply, such a transcript together with such a still reproduction; ‘ relevant person ’ means— (a) the Minister, (b) the Chief Executive, (c) the Chief Executive Officer of the Health Service Executive, or (d) the Council of the Pharmaceutical Society of Ireland; ‘ relevant thing ’ means— (a) any medicinal product, cosmetic product or medical device, and (b) any article or substance used in the manufacture, processing or storage of any medicinal product, cosmetic product or medical device; ‘ this Act ’ includes any regulations— (a) made under this Act, or (b) referred to in section 34(4).

Authorised officers.

32B.— (1) A relevant person— (a) may appoint such and so many persons as the relevant person thinks fit to be authorised officers for the purposes of this Act, and (b) shall furnish each authorised officer appointed by the relevant person with a warrant of the authorised officer’s appointment.

(i) without payment, take possession of and remove from the premises for any test, examination or analysis any relevant thing found there, and detain it for such period as he or she considers reasonably necessary for the purposes of his or her functions under this Act, (j) without payment, take samples of any relevant thing, detained pursuant to paragraph (i), for the purposes of any test, examination, or analysis, (k) where the taking of samples of any relevant thing pursuant to paragraph (f) or (j) is, for whatever reason, not practicable, without payment take the relevant thing concerned for the purposes of any test, examination or analysis, (l) inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 and 2003, (m) require a person, having authority to do so, to break open any container or package, or to open any vending machine, or to permit him or her to do so, as he or she may reasonably require for the purposes of his or her functions under this Act, or (n) require a person, who makes available facilities such as post office boxes, telecommunications or electronic mail address or other like facilities, to give him or her such assistance and information as he or she may reasonably require for the purposes of his or her functions under this Act in any case where the officer has reasonable grounds for believing that any relevant thing is being supplied by mail.

Taking of samples, etc., by authorised officers.

32C.— (1) Subject to subsection (3), where an authorised officer takes a sample of a relevant thing pursuant to section 32B(3)(f) or (j), he or she shall— (a) divide the sample into 3 approximately equal parts, (b) place each part into separate containers, and (c) forthwith seal and mark each such container in such a manner as to identify it as part of the sample taken by that authorised officer.

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

32D.— (1) In any proceedings for an offence under this Act, a certificate in the form specified in Schedule 2 to this Act signed by— (a) either— (i) the State Chemist, or (ii) another chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign the certificate, (b) either— (i) a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875 , or (ii) another analyst authorised by such a public analyst to sign the certificate, or (c) a chemist or analyst appointed by the Board or the Council of the Pharmaceutical Society of Ireland, stating the result of any test, examination or analysis of a sample of any relevant thing, or of a relevant thing, as the case may be, forwarded under section 32C(2)(c) or (4)(c) shall, with regard to that sample of the relevant thing, or the relevant thing, as the case may be, be evidence of the matters stated in the certificate unless the contrary is proved.

Penalties for offences.

32E.— (1) A person guilty of an offence under section 32B(7) or (10) shall be liable on summary conviction to a fine not exceeding €2,000, or to imprisonment for a term not exceeding 3 months, or to both.

Proceedings.

32F.— (1) Summary proceedings for an offence under this Act may be brought and prosecuted by a relevant person.

Amendment of section 35 of Irish Medicines Board Act 1995 (amendment of enactments).

18.— Section 35(1) of the Irish Medicines Board Act 1995 is amended by substituting “Schedule 1” for “the Schedule”.

Amendment of Schedule to Irish Medicines Board Act 1995.

19.— The Schedule to the Irish Medicines Board Act 1995 is amended by substituting “SCHEDULE 1” for “SCHEDULE”.

Insertion of new Schedule 2 into Irish Medicines Board Act 1995.

20.— The Irish Medicines Board Act 1995 is amended by inserting the following after Schedule 1 to that Act (as amended by section 19 of this Act):

Section 32D. “SCHEDULE 2 IRISH MEDICINES BOARD ACT 1995 (AS AMENDED BY THE IRISH MEDICINES BOARD (MISCELLANEOUS PROVISIONS) ACT 2006) Certificate Stating Results of Test, Examination or Analysis This certificate is issued by me, the undersigned, for the purpose of section 32D of the Irish Medicines Board Act 1995 (as amended by section 17 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006), being— 1.

I hereby certify that I received, on the day of , from 2 of a sample of the relevant thing/the relevant thing*, being 3 for test, examination or analysis; which was undamaged, duly sealed and marked 4.

I further certify that the said sample/relevant thing* has been tested, examined or analysed by me or under my direction and that the results are as follows— 5 Signature Date Address 1. Here insert official title of person signing the certificate.

PART 4

Amendment of Control of Clinical Trials Act 1987 Amendment of section 1 of Control of Clinical Trials Act 1987 (interpretation).

21.— Section 1(1) of the Control of Clinical Trials Act 1987 is amended— (a) by inserting after the definition of “administered” the following: “‘ authorised officer ’ means an authorised officer appointed under section 15A(1);”; (b) by inserting the following after the definition of “ethics committee”: “ ‘ Irish Medicines Board ’ means the Irish Medicines Board established under section 3 of the Irish Medicines Board Act 1995 ; ‘ medical device ’ means medical device within the meaning of section 1(1) of the Irish Medicines Board Act 1995 ;”; and (c) by inserting the following after the definition of “participant”: “ ‘ premises ’ includes any aircraft, hovercraft, ship, stall or vehicle; ‘ record ’ includes, in addition to a record in writing— (a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form, (b) a film, tape or other device in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and (c) a photograph, and any reference to a copy of a record includes— (d) in the case of a record to which paragraph (a) of this definition applies, a transcript of the sounds or signals embodied therein, (e) in the case of a record to which paragraph (b) of this definition applies, a still reproduction of the images embodied therein, and (f) in the case of a record to which paragraphs (a) and (b) of this definition apply, such a transcript together with such a still reproduction;”.

Amendment of section 2 of Control of Clinical Trials Act 1987 (restriction on application of Act, etc.).

22.—

Section 2

of the Control of Clinical Trials Act 1987 is amended by inserting the following after subsection (3): “(4) The provisions of this Act shall not apply in respect of any clinical trial that is subject to control under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ).”.

Amendment of section 13 of Control of Clinical Trials Act 1987 (offences).

23.—

Section 13

of the Control of Clinical Trials Act 1987 is amended— (a) in subsection (3), by substituting “2 years” for “12 months”; and (b) by inserting the following after subsection (3): “(4) An offence under this section may be prosecuted summarily by the Irish Medicines Board.”.

Insertion of new section 15A into Control of Clinical Trials Act 1987 (authorised officers).

24.— The Control of Clinical Trials Act 1987 is amended by inserting the following after section 15: “Authorised officers.

15A.— (1) The Irish Medicines Board may appoint any of its officers to be authorised officers for the purposes of this Act and any regulations under this Act.

PART 5

Amendment of Health Acts 1947 to 2005 Amendment of section 54 of Health Act 1947 (regulations for prevention of danger from food and drink).

25.—

Section 54

of the Health Act 1947 (as amended by the European Communities (Health Act 1947 Amendment of Sections 54 and 61) Regulations 1991 ( S.I. No. 333 of 1991 )) is repealed and the following substituted: “Regulations for prevention of danger from food and drink.

54.— (1) The Minister may, after consultation with the Minister for Enterprise, Trade and Employment and the Minister for Agriculture and Food, make regulations providing for— (a) the prevention of danger to the public health arising from the manufacture, preparation, importation, storage, distribution or exposure for sale of food intended for sale for human consumption, (b) the prevention of contamination of food intended for sale for human consumption, (c) the prohibition and prevention of the sale or offering or keeping for sale of— (i) articles of food intended for human consumption, (ii) living animals intended for such food, (iii) materials or articles used or intended for use in the preparation or manufacture of such food, which are diseased, contaminated or otherwise unfit for human consumption, (d) the protection of consumer interests (including regulations requiring persons operating in the retail, restaurant or catering sectors to provide information on the country of origin of meat sold or otherwise supplied to consumers where, in the opinion of the Minister, such information is not already adequately provided under national or EU legislation), (e) 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 the official control of foodstuffs for the protection of health.

Amendment of section 59 of Health Act 1970.

26.— Section 59(2) of the Health Act 1970 is amended by inserting “, or on the prescription of a registered nurse (being a person whose name is entered in the register of nurses maintained under section 27 of the Nurses Act 1985 ) entitled pursuant to any enactment to prescribe the drugs, medicines or medical or surgical appliances so obtained,” after “practitioner”.

Amendment of section 66 of Health Act 1970 (child health service).

27.—

Section 66

of the Health Act 1970 is amended by substituting the following for subsections (2), (3) and (4): “(2) The Health Service Executive shall make available without charge a health examination and treatment service for pupils who attend any primary school or who are taught at home.

Amendment of section 67 of Health Act 1970 (dental, ophthalmic and aural services).

28.—

Section 67

of the Health Act 1970 is amended— (a) in subsection (1), by deleting “and persons with limited eligibility”, (b) in subsection (3), by substituting “Charges” for “Save as provided for under subsection (4), charges,”, and (c) by deleting subsection (4).

Amendment of section 1 of Health (Amendment) Act 1994 (free dental health services for children).

29.— Section 1(1) of the Health (Amendment) Act 1994 is amended by substituting “any primary school or who are taught at home, and who” for “national school or a school standing specified in an order under section 66

PART 6

Consequential Amendments to Regulations Made Under Section 32 of Irish Medicines Board Act 1995 or Referred to in Section 34(4) of that Act Amendment of regulation 3 of Medical Preparations (Wholesale Licences) Regulations 1993.

30.— Regulation 3 of the Medical Preparations (Wholesale Licences) Regulations 1993 ( S.I. No. 39 of 1993 ) (as amended by the Medicinal Products (Amendment) Regulations 2004 ( S.I. No. 663 of 2004 )) is amended by deleting the definition of “State Chemist”.

Revocation of regulations 11, 12 and 13 of, and Schedule to, Medical Preparations (Wholesale Licences) Regulations 1993.

31.— The Medical Preparations (Wholesale Licences) Regulations 1993 ( S.I. No. 39 of 1993 ) (as amended by the Medical Preparations (Wholesale Licences) (Amendment) Regulations 1996 ( S.I. No. 41 of 1996 ) and the Medicinal Products (Amendment) Regulations 2004 ( S.I. No. 663 of 2004 )) are amended by revoking regulations 11, 12 and 13 and the Schedule.

Amendment of regulation 3 of Medical Preparations (Licensing of Manufacture) Regulations 1993.

32.— Regulation 3 of the Medical Preparations (Licensing of Manufacture) Regulations 1993 ( S.I. No. 40 of 1993 ) (as amended by the Medicinal Products (Amendment) Regulations 2004 ( S.I. No. 663 of 2004 )) is amended by deleting the definition of “State Chemist”.

Revocation of regulations 11, 12 and 13 of, and Schedule III to, Medical Preparations (Licensing of Manufacture) Regulations 1993.

33.— The Medical Preparations (Licensing of Manufacture) Regulations 1993 ( S.I. No. 40 of 1993 ) (as amended by the Medical Preparations (Licensing of Manufacture) (Amendment) Regulations 1996 ( S.I. No. 42 of 1996 ) and the Medicinal Products (Amendment) Regulations 2004 ( S.I. No. 663 of 2004 )) are amended by revoking regulations 11, 12 and 13 and Schedule III.

Revocation of regulation 13 of Medical Preparations (Labelling and Package Leaflets) Regulations 1993.

34.— The Medical Preparations (Labelling and Package Leaflets) Regulations 1993 ( S.I. No. 71 of 1993 ) (as amended by the Medical Preparations (Labelling and Package Leaflets) (Amendment) Regulations 1999 ( S.I. No. 187 of 1999 )) are amended by revoking regulation 13.

Amendment of regulation 2 of Medicinal Products (Licensing and Sale) Regulations 1998.

35.— Regulation 2 of the Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ) (as amended by the Medicinal Products (Amendment) Regulations 2004 ( S.I. No. 663 of 2004 )) is amended by deleting the definition of “State Chemist”.

Revocation of regulations 12, 13 and 13A of, and Second Schedule to, Medicinal Products (Licensing and Sale) Regulations 1998.

36.— The Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ) (as amended by the Medicinal Products (Amendment) Regulations 2004 ( S.I. No. 663 of 2004 )) are amended by revoking regulations 12, 13 and 13A and the Second Schedule.

Amendment of regulation 4(1) of Medicinal Products (Prescription and Control of Supply) Regulations 2003 (interpretation).

37.— Regulation 4(1) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ) is amended by deleting the definition of “authorised officer”.

Revocation of regulations 21 and 22 of, and Sixth Schedule to, Medicinal Products (Prescription and Control of Supply) Regulations 2003.

38.— The Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ) are amended by revoking regulations 21 and 22 and the Sixth Schedule.

Amendment of regulation 23 of Medicinal Products (Prescription and Control of Supply) Regulations 2003.

39.— Regulation 23 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ) is amended by substituting “section 32B of the Act” for “regulation 21 herein”.

Revocation of regulation 18 of Medical Preparations (Advertising) Regulations 1993.

40.— The Medical Preparations (Advertising) Regulations 1993 ( S.I. No. 76 of 1993 ) are amended by revoking regulation 18.

PART 7

Amendment of Animal Remedies Act 1993 Regulations and fees and increase of fines.

41.— (1) The Animal Remedies Act 1993 is amended— (a) in section 8(1)— (i) in paragraph (a)(iii), by inserting “and any building or structure containing such” after “animal remedies”, and (ii) in paragraph (b)(iii)(I) and (II), by inserting “or certificates” after “authorisations”, (b) in section 23— (i) in subsection (1)— (I) in paragraph (a), by substituting “€5,000” for “£1,000”, and (II) in paragraph (b), by substituting— (A) in subparagraph (i), “€150,000” for “£100,000”, and (B) in subparagraph (ii), “€350,000” for “£250,000”, and (ii) in subsection (2)— (I) in paragraph (a), by substituting “€5,000” for “£1,000”, and (II) in paragraph (b), by substituting— (A) in subparagraph (i), “€50,000” for “£25,000”, and (B) in subparagraph (ii), “€100,000” for “£50,000”, and (c) in section 29— (i) by substituting for subsection (1) the following: “(1) There shall be paid— (a) on an application for the grant of a licence the issue of an authorisation or a certificate or the provision of a service under regulations made under section 8 or a renewal or amendment of any of them, such fee (if any), (b) in respect of a licence, authorisation or certificate under regulations made under section 8 which is in force for a definite or indefinite period of more than 12 months, such annual fee (if any), and (c) in respect of any fee or levy to which regulations made under section 8(2)(b)(vii) relate, such fee or levy.”, (ii) in subsection (2), by substituting “licences, authorisations, certificates or services” for “licences or authorisations”, and (iii) in subsection (3)(b)(i), by substituting “authorisations or certificates” for “authorisations”.

1 OJ L22, 26.01.2005, p.1 2OJ L189, 20.07.1990, p.17 3OJ L169, 12.07.1993, p.1 4OJ L331, 07.12.1998, p.1 5OJ L311, 28.11.2001, p.67 6OJ L311, 28.11.2001, p.1 7OJ L136, 30.04.2004, p.1 8OJ L121, 01.05.2001, p.34 9OJ L262, 27.09.1976, p.169 10OJ L140, 23.06.1995, p.26 11OJ L102, 07.04.2004, p.48 12 OJ L311, 28.11.2001, p.67 13 OJ L31, 01.02.2002, p.1 Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais