S.I. No. 502/2025 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2025

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 28th October, 2025.

I, JENNIFER CARROLL MACNEILL, Minister for Health, in exercise of the powers conferred on me by section 32 (as amended by section 9 of the Health (Miscellaneous Provisions) Act 2024 (No. 23 of 2024)) of the Irish Medicines Board Act 1995 (No. 29 of 1995), hereby make the following regulations:

1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2025.

(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2025” includes these regulations.

2. In these Regulations —

“Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 );

“Regulation of Retail Pharmacy Businesses Regulations” means the Regulation of Retail Pharmacy Businesses Regulations 2008 to 2025;

“Society” means the Pharmaceutical Society of Ireland.

3. Regulation 4(1) (as amended by Regulation 3 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2023 ( S.I. No. 284 of 2023 )) of the Principal Regulations is amended —

(a) by inserting after the definition of “clinical practice guidelines” the following definitions:

“‘Common Conditions Service’ means a service that may be provided by a registered pharmacist practising in a retail pharmacy business, which may include the provision of a prescription for a medicinal product listed in Schedule 13, following appropriate advice and counselling. Delivery of a Common Conditions Service by a registered pharmacist will be subject to that pharmacist adhering to CCSP;

‘Common Conditions Service Protocols (“CCSP”)’ mean the protocols developed by the Health Service Executive and approved by the Minister for Health for use in a Common Conditions Service;”.

(b) by inserting after paragraph (e) in the definition of “prescription” the following paragraph:

“(f) a registered pharmacist who is practising in, and operating under the governance of, a retail pharmacy business and is issuing a prescription as part of a Common Conditions Service, which is provided in that retail pharmacy business;”; and

(c) by substituting for the definition of “professional registration number” the following definition:

“‘professional registration number’ means—

(a) in the case of a registered medical practitioner, the number attached to the medical practitioner’s registration in accordance with section 43 (5) of the Medical Practitioners Act 2007 (No. 25 of 2007),

(b) in the case of a registered nurse, the number attached to the nurse’s registration in accordance with section 46 (7) of the Nurses and Midwives Act 2011 (No. 41 of 2011),

(c) in the case of a registered dentist, the number assigned by the Dental Council to the dentist’s registration in the Register of Dentists in accordance with section 26 of the Dentists Act 1985; or

(d) in the case of a registered pharmacist, the number attached to the pharmacist’s registration in accordance with section 13 of the Pharmacy Act, 2007;”.

4. Regulation 4A of the Principal Regulations (as amended by Regulation 2 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009 ( S.I. No. 442 of 2009 )) is amended —

(a) by substituting for subparagraph (c) of paragraph (1) the following subparagraph:

“(c) Any person, other than a registered medical practitioner or registered dentist, to administer to a patient, in accordance with the directions of a registered medical practitioner or registered dentist or in accordance with a prescription issued by a registered pharmacist, any medicinal product subject to control by virtue of these Regulations.”; and

(b) by inserting after paragraph (2) the following paragraph:

“(3) In paragraph (1) a reference to a registered pharmacist shall be construed as a reference to a registered pharmacist acting in the course of his or her practice as a pharmacist.”

5. The Principal Regulations are amended by inserting after Regulation 5B (inserted by Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 ( S.I. No. 201 of 2007 )) the following Regulation:

“Prescription by registered pharmacists in the context of a Common Conditions Service

5C. (1) Subject to paragraph (3), a registered pharmacist may only issue a prescription for a medicinal product listed in Schedule 13, where the following conditions are satisfied:

(a) the prescription is issued as part of a Common Conditions Service provided in a retail pharmacy business;

(b) the registered pharmacist has satisfactorily completed training as specified by the Society in accordance with education and training rules made by the Society.

(c) the medicinal product is prescribed by the registered pharmacist for the purpose set out in Schedule 13, and in accordance with the CCSP.

(2) Nothing in this Regulation shall be construed as restricting the performance of any function conferred on the Society under the Pharmacy Act 2007 (No. 20 of 2007); or any other enactment or statutory instrument.”.

6. Regulation 7(1) (as amended by Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2024 ( S.I. No. 73 of 2024 )) of the Principal Regulations is amended –

(a) in subparagraph (c), by substituting for clause (i) the following:

“whether he or she is a registered medical practitioner, registered dentist, registered nurse or registered pharmacist; and”; and

(b) in subparagraph (c), by inserting after clause (ii) the following:

“(iii) in the case of a registered pharmacist, the registration number assigned to the pharmacist in the register of pharmacists established under section 13 of the Pharmacy Act, 2007; and”.

7. The Principal Regulations are amended by inserting after Regulation 10E (as inserted by Regulation 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2024 ( S.I. No. 73 of 2024 )) the following regulations:

“Keeping of records in relation to a Common Conditions Service

10F. A registered pharmacist who makes a decision to issue a prescription for a medicinal product listed in Schedule 13 pursuant to Regulation 5C(1), shall, on the making of such decision in relation to a prescription, make an entry, in the register kept in accordance with Regulation 10(1), recording the following particulars:

(a) the date of the decision;

(b) the name and registration number of the registered pharmacist who made the decision to issue the prescription; and

(c) details of the prescription.

8. The Principal Regulations are amended by inserting after the Twelfth Schedule (as amended by Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2025 ( S.I. No. 418 of 2025 )) the following Schedule:

THIRTEENTH SCHEDULE

Regulation 5C

Medicinal products which may be prescribed by registered pharmacists

GIVEN under my Official Seal,

22 October, 2025.

JENNIFER CARROLL MACNEILL,

Minister for Health.

EXPLANATORY NOTE

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

These Regulations amend the Medicinal Products (Prescription and Control of Supply) Regulations 2003.

The purpose of these Regulations is to provide for prescribing by registered pharmacists of certain medicinal products, in accordance with specific protocols, as part of a Common Conditions Service.

These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2025.