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

STATUTORY INSTRUMENTS

S.I. No. 663 of 2004

Medicinal Products (Amendment) Regulations 2004

S.I. No. 663 of 2004

Medicinal Products (Amendment) Regulations 2004

I, Mary Harney, Minister for Health and Children, in exercise of the powers conferred on me by section 32 of the Irish Medicines Board Act 1995 (No. 29 of 1995), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997 ( S.I. No. 308 of 1997 ), hereby make the following regulations:-

1. These Regulations may be cited as the Medicinal Products (Amendment) Regulations 2004.

2. Regulation 11 of the Medical Preparations (Wholesale Licences) Regulations 1993 ( S.I. No. 39 of 1993 ) (as amended), Regulation 11 of the Medical Preparations (Licensing of Manufacture) Regulations 1993 ( S.I. No 40 of 1993 ) (as amended) and Regulation 12 of the Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ) (as amended) are each hereby substituted by the following provisions:

“(1) (a) The Minister may appoint such and so many officers as he or she thinks fit to be authorised officers for the purposes of these Regulations.

(b) The Pharmaceutical Society of Ireland may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(c) The Chief Executive Officer of each health board may appoint such and so many officers as he or she thinks fit to be authorised officers for the purposes of these Regulations.

(d) The Irish Medicines Board may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(2) (a) An authorised officer shall be furnished with a warrant of his or her appointment.

(b) When exercising a power conferred on him or her under this Regulation, an authorised officer shall, if required by a person thereby affected, produce the warrant to that person for inspection.

(3) Subject to paragraphs (4) and (5) an authorised officer may, for the purpose ensuring of that these Regulations are being complied with -

(a) at all reasonable times, enter any premises or place where he or she has reason to believe there is -

(i) a medicinal product to which these Regulations relate, or

(ii) any book, invoice, order, record, register or other document relating to any such product (including documentation relating to labelling and packaging)

and to inspect and search the said premises or place,

(b) inspect any substance or product which is stored, or offered or kept for supply at such premises or place,

(c) require the production of, inspect and, if he or she thinks fit, take copies of any book, invoice, order, record, register, or other document (including documentation relating to labelling and packaging) or of any entry in any such book, invoice, order, record register, or other documentation at such premises or place,

(d) remove any such book, invoice, order, record, register or other document (including documentation relating to labelling and packaging) from such premises or place and detain them for such period as he or she reasonably considers to be necessary for the purposes of his or her functions under these Regulations,

(e) inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 and 2003, found by or produced to the officer under these Regulations,

(f) take (without payment) samples of any medicinal product or substance for test, examination or analysis,

(g) seize and detain any medicinal product, substance or article,

(h) take any document which he or she has reasonable cause to believe to be a document which may be required as evidence in proceedings under the Irish Medicines Board Act 1995 .

(4) An authorised officer shall not other than with the consent of the occupier enter a private dwelling or such part of any premises (not being a shop) as is used by a registered medical practitioner or registered dentist for carrying on his or her professional practice unless he or she has obtained a warrant from the District Court under paragraph (8) authorising such entry.

(5) So much of paragraph (3) as enables officers of the Pharmaceutical Society of Ireland to enter premises of any class or description shall not apply as respects any of the following premises -

(a) a hospital;

(b) the premises of a manufacturer of a medicinal product.

(6) An authorised officer, for the purpose of exercising any of the powers conferred on him or her by paragraph (3), may require any other 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.

(7) Where an authorised officer seizes any medicinal product, substance, article or document in the exercise of a power conferred on him or her by paragraph (3), he or she shall inform the person from whom it is seized, and, in the case of any medicinal product seized from a vending machine, the person whose name and address are stated on the machine, or if no name and address are so stated, the occupier of the premises on which the machine stands or to which it is affixed, of that fact.

(8) If a judge of the District Court is satisfied, on the sworn information of an authorised officer, that there are reasonable grounds to authorise entry into any of those premises set out at paragraph (4) herein, the judge may issue a warrant authorising such an authorised officer accompanied by such other authorised officers or members of An Garda Síochána or such other persons as may be necessary, at any time or times within one month from the date of issue of the warrant, on production of the warrant requested, to enter those premises or part thereof, if need be by reasonable force, and to exercise any of the powers conferred on such an authorised officer under these Regulations.

(9) A person shall not wilfully obstruct or interfere with the exercise of a power by an authorised officer pursuant to these Regulations.

(10) A person shall not, without reasonable excuse, fail to comply with any request made by an authorised officer under these Regulations.”

3. Regulations 12 and 13 of the Medical Preparations (Wholesale Licences) Regulations 1993 ( S.I. No. 39 of 1993 ) as amended, are hereby substituted by the following Regulation:

“12 (1) In any proceedings for an offence under section 32 of the Irish Medicines Board Act 1995 in relation to these Regulations, a certificate signed by —

(a) the State Chemist, or such other chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign any such certificate, or

(b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875 (38 & 39 Vic., c.63), or such other analyst authorised by such public analyst to sign any such certificate, or

- stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of the result of such test.

(2) The certificate referred to in paragraph (1) shall be in the form set out in the Schedule.”.

4. The Medical Preparations (Licensing of Manufacture) Regulations 1993 ( S.I. No 40 of 1993 ) (as amended) are hereby amended by: -

(a) the insertion of the following Regulation after Regulation 11 —

“12 (1) In any proceedings for an offence under section 32 of the Irish Medicines Board Act 1995 in relation to these Regulations, a certificate signed by —

(a) the State Chemist, or such other chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign any such certificate, or

(b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875 (38 & 39 Vic., c.63), or such other analyst authorised by such public analyst to sign any such certificate, or

- stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of the result of such test.

(2) The certificate referred to in paragraph (1) shall be in the form set out in Schedule III.”; and

(b) the insertion of the Schedule to these Regulations after Schedule II.

5. The Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ) are hereby amended by the substitution of the following Regulation for Regulation 13 —

“13 (1) In any proceedings for an offence under section 32 of the Irish Medicines Board Act 1995 in relation to these Regulations, a certificate signed by —

(a) the State Chemist, or such other chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign any such certificate, or

(b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875 (38 & 39 Vic., c.63), or such other analyst authorised by such public analyst to sign any such certificate, or

- stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of the result of such test.

(2) The certificate referred to in paragraph (1) shall be in the form set out in the Second Schedule.”.

6. The Medical Preparations (Wholesale Licences) Regulations 1993 ( S.I. No. 39 of 1993 ) and the Medicinal Products (Licensing of Manufacture) Regulations 1993 ( S.I. No 40 of 1993 ) are hereby amended by the insertion of the following Regulation after Regulation 12 —

“13. (1) Where an authorised officer takes a sample of a medicinal product or a sample of a substance, for the purposes of these Regulations, he or she shall divide the sample into three approximately equal parts, and place each part into separate containers which he or she shall forthwith seal and mark in such a manner as to identify it as part of the sample taken by that authorised officer.

(2) Where an authorised officer has complied with paragraph (1) he or she shall —

(a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the medicinal product or substance from which the sample concerned was taken,

(b) retain one of the sealed containers, and

(c) forward, or cause to be forwarded, one of the sealed containers for analysis by one of the persons referred to in Regulation 12 (1)(a), (b), or (c).

(3) Where a medicinal product or a substance is contained in a container and its division into parts is (for whatever reason) not practicable, an authorised officer, who wishes to take samples of such medicinal product or substance for the purposes of analysis, shall take possession of three such containers belonging to the same batch, and each such container shall be deemed to be part of a sample for the purposes of paragraph (1) and the provisions of paragraphs (1) and (2) shall apply thereto accordingly.”

7. The Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ) are hereby amended by the insertion of the following Regulation after Regulation 13 —

“13A. (1) Where an authorised officer takes a sample of a medicinal product or a sample of a substance, for the purposes of these Regulations, he or she shall divide the sample into three approximately equal parts, and place each part into separate containers which he or she shall forthwith seal and mark in such a manner as to identify it as part of the sample taken by that authorised officer.

(2) Where an authorised officer has complied with paragraph (1) he or she shall —

(a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the medicinal product or substance from which the sample concerned was taken,

(b) retain one of the sealed containers, and

(c) forward, or cause to be forwarded, one of the sealed containers for analysis by one of the persons referred to in Regulation 13 (1)(a), (b), or (c).

8. Any reference in the Medicinal Products (Licensing and Sale) Regulations 1998 (S.I. 142 of 1998) to the Medicinal Products (Prescription and Control of Supply) Regulations 1996 (S.I. 256 and 309 of 1996) shall be construed as a reference to the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. 540 of 2003).

9. (1) Regulation 3 of the Medical Preparations (Wholesale Licences) Regulations 1993 ( S.I. No. 39 of 1993 ) is hereby amended by the insertion of the definition —

““State Chemist” means the head of the State Laboratory;”

- after the definition of “sale by wholesale”.

(2) Regulation 3 of the Medical Preparations (Licensing of Manufacture) Regulations 1993 ( S.I. No. 40 of 1993 ) is hereby amended by the insertion of the definition —

““State Chemist” means the head of the State Laboratory;”

after the definition of “retail sale”.

(3) Regulation 2 of the Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ) is hereby amended by the insertion of the definition —

““State Chemist” means the head of the State Laboratory;”

after the definition of “sell”.

Schedule

“Schedule III

Regulation 12

Medical Preparations (Licensing of Manufacture) Regulations 1993

( S.I. No 40 of 1993 )

CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS

This Certificate is issued by me, the undersigned, for the purpose of Regulation 15 of the Medical Preparations (Licensing of Manufacture) Regulations 1993, being

⁽¹⁾ __________ _______________________.

I hereby certify that I received, on the _____ day of _________

20 ____, from ⁽²⁾ ___________________ of ___________________________ a sample of ⁽³⁾ _________________ for test, examination or analysis; which was undamaged, duly sealed and marked ⁽⁴⁾ ________________.

I further certify that the said sample 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 analyst.

⁽²⁾ Here insert the name of the sampling officer who submitted the sample for analysis.

⁽³⁾ Here insert the name or description of the product.

⁽⁴⁾ Here insert the distinguishing mark on the sample and the date of sampling shown thereon.

⁽⁵⁾ Here inser the relevant results as appropriate.

/images/seal.jpg

GIVEN under my Official Seal

this 18^th day of October 2004.

Mary Harney

________________________

Minister for Health and Children

Explanatory Note

(This note is not part of the Instrument and does not purport to be a legal interpretation)

The purpose of these Regulations is to ensure consistency in the inspection procedures and powers of officers authorised under the Medical Preparations (Wholesale Licences) Regulations 1993 ( SI No 39 of 1993 )(as amended), the Medical Preparations (Licensing of Manufacture) Regulations 1993 ( S.I. No 40 of 1993 ) (as amended) and the Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ) (as amended).

These Regulations provide for the handling of samples taken in the course of enforcement and for the recognition of certificates of analysis in the course of court proceedings. The Regulations also provide powers to obtain warrants from a District Court Judge authorising the inspection of premises that may be used as private dwellings.