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


S.I. No. 201 of 2007

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007

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, as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006), hereby make the following Regulations:

Citation

1.         These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007.

Definition.

2.         In these Regulations, “Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003) as amended by the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 (S.I. No. 510 of 2005).

Amendment of Regulation 4 of Principal Regulations.

3.         Regulation 4(1) of the Principal Regulations is amended by substituting the following for the definition of “prescription”:

““prescription” means a prescription issued by -

(a)       a registered medical practitioner or registered dentist;

(b)       a practitioner, of status equivalent to a registered medical practitioner or registered dentist, practising in another Member State if, and only if -

(i)         the address of the practitioner in that Member State is shown on the prescription;

(ii)        the practitioner is not connected with any practice of medicine or dentistry in the State; and

(iii)       the prescription has not been issued with a view to enabling the supply of a medicinal product by mail order; or

(c)       a registered nurse;”.

Insertion of new Regulations 5A and 5B into Principal Regulations.

4.         The Principal Regulations are amended by inserting the following after Regulation 5:

“Prescription by registered nurses.

5A.      (1)       Subject to paragraph (2), a registered nurse shall not issue a prescription for a medicinal product referred to in Regulation 5(1) unless the following conditions are satisfied:

(a)        the nurse is employed by a health service provider in a hospital, nursing home, clinic or other health service setting (including any case where the health service is provided in a private home);

(b)        the medicinal product is a medicinal product which would be given in the usual course of the provision of the health service provided in the health service setting in which the nurse is employed; and

(c)        the prescription is in fact issued in the usual course of the provision of that health service.

(2)       Nothing in this Regulation shall be construed as restricting -

(a)        a health service provider from -

(i)        prohibiting a registered nurse employed by the provider from issuing, in the course of that employment, a prescription for any medicinal product, or any class of medicinal product, for which the nurse may otherwise issue a prescription pursuant to these Regulations; or

(ii)        imposing conditions, in addition to those referred to in paragraph (1), which must be satisfied before a registered nurse employed by the provider may issue a prescription pursuant to these Regulations; or

(b)        the performance of any function conferred on An Bord Altranais under -

(i)        the Nurses Act 1985 (No. 18 of 1985); or

(ii)       any other enactment or statutory instrument.

(3)       In this Regulation, “health service provider” means the Health Service Executive, a hospital, a nursing home, a clinic or other person whose sole or principal activity or business is the provision of health services, or a class of health services, to the public or a class of the public.

Person may refuse to supply medicinal product if reasonable cause to believe conditions referred to in Regulation 5A(1) have not been satisfied.

5B.      Without prejudice to the generality of the other provisions of these Regulations pursuant to which a person may refuse to supply a medicinal product, a person may refuse to supply a medicinal product pursuant to a prescription issued by a registered nurse if the person has reasonable cause to believe that the conditions referred to in Regulation 5A(1) have not been satisfied in relation to the nurse, the medicinal product and the prescription.”.

Amendment of Regulation 7 of Principal Regulations.

5.         Regulation 7(1) of the Principal Regulations is amended by substituting the following for paragraph (c):

“(c)      clearly indicate the name of the person issuing it and state -

(i)         whether he of she is a registered medical practitioner, registered dentist or registered nurse; and

(ii)        in the case of a registered nurse, the registration number assigned to the nurse in the register of nurses established under section 27 of the Nurses Act 1985; and”.

Amendment of Regulation 8 of Principal Regulations.

6.         Regulation 8 of the Principal Regulations is amended -

(a)      in paragraph (1) -

(i)         in subparagraph (a), by substituting “, registered dentist or registered nurse” for “or registered dentist”; and

(ii)        in subparagraphs (b) and (c), by inserting “or nurse” after “practitioner”; and

(b)      in paragraph (2)(a)(ii), by inserting “, registered dentist or registered nurse” after “practitioner”.

 

GIVEN under my Official Seal,

1 May 2007.

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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).

This Order may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007.

The purpose of these Regulations is to allow registered nurses to prescribe medicinal products in certain circumstances.

Department of Health and Children

1 May 2007