S.I. No. 503/2025 - Regulation of Retail Pharmacy Businesses (Amendment) 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 18 of the Pharmacy Act 2007 (No. 20 of 2007), hereby make the following regulations:

1. (1) These Regulations may be cited as the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2025.

(2) The Principal Regulations and these Regulations may be cited together as the Regulation of Retail Pharmacy Businesses Regulations 2008 to 2025 and shall be construed together as one.

2. In these Regulations—

“Principal Regulations” means the Regulation of Retail Pharmacy Businesses Regulations 2008 ( S.I. No. 488 of 2008 );

“Medicinal Products Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2025.

3. The Principal Regulations are amended—

(a) in Regulation 3, by inserting after the definition of “certificate of registration” and before the definition of “Council”, the following—

““Common Conditions Service’ has the same meaning as it has in the Medicinal Products Regulations;

“‘Common Conditions Service Protocols (“CCSP”)’ has the same meaning as it has in the Medicinal Products Regulations;”;

(b) in Regulation 4—

(i) by inserting after Regulation 1(b), the following—

“(c) Parts (a) and (b) of this Regulation also apply to a Common Conditions Service, as the prescribing activity that may happen in the provision of that service.”;

(c) in Regulation 5, by substituting for paragraph (2), the following—

“(2) The requirements of paragraph—

(a) (1) apply to persons employed or engaged in a retail pharmacy business in which a Common Conditions Service is provided, and

(b) (1)(h) and (i) apply to persons employed or engaged in a retail pharmacy business that consists of, or includes, the sale or supply of veterinary medicinal products.”.

(d) in Regulation 9, by inserting after paragraph 9A(4) the following Regulation (as inserted by Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2024) :

“Providing a Common Conditions Service

9B (1) Where a Common Conditions Service is provided in a retail pharmacy business, the person carrying on a retail pharmacy business, the superintendent pharmacist, and the supervising pharmacist shall ensure that—

(a) the services adhere to the guidance put in place by the Pharmaceutical Society of Ireland and any CCSP approved by the Minister for Health,

(b) the pharmacist provides advice having regard to proper patient care and, if required to prescribe, does so with regard to the pharmaceutical and therapeutic appropriateness of the medicine therapy,

(c) in recommending any treatment, the pharmacist has engaged in dialogue with the patient or the carer of such a patient in the separate and designated area referred to in Regulation 4(3) and sought to ascertain any history with the medicine therapy or course of treatment,

(d) the pharmacist has retained a record of the consultation, and

(e) where a prescription is issued in the course of the provision of the service, prescribing and dispensing can occur in the same pharmacy, if it is in the best interest of the patient and if it is the patient’s choice that this should happen.

(2) Where a Common Conditions Service is provided in a retail pharmacy business and a medicinal product is supplied to the patient in the course of that service—

(a) and subject to paragraph 1(e) of this Regulation, that product may be dispensed in the same pharmacy, and

(b) Regulation 9(1), (2) and (3) apply to the dispensing and supply of the product.”,

(e) in Regulation 10, by inserting after “prescription” and before “and prior” the following—

“whether that product is sold or supplied under a Common Conditions Service, or otherwise”, and

(f) in Regulation 12(1)—

(i) (b), by deleting the word “and”,

(ii) (c), by substituting for “pharmacy.”, the following “pharmacy, and”, and

(iii) by inserting after paragraph (c), the following—

“(d) such other records in electronic form as will enable the identification of a patient in respect of whom a medicinal product has been supplied on foot of a prescription issued by a pharmacist as part of a Common Conditions Service, together with that patient’s medication record in respect of his or her previous supplies of medicinal products made by the pharmacy.”.

GIVEN under my Official Seal,

23 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 Regulation of Retail Pharmacy Businesses Regulations 2008.

These Regulations set out certain requirements to be complied with by persons carrying on retail pharmacy businesses in their provision of a Common Conditions Service.

These Regulations may be cited as the Regulation of Retail Pharmacy Businesses Regulations 2025.