S.I. No. 140/2026 - Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2026

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 14th April, 2026.

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. These Regulations may be cited as the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2026.

2. The Regulation of Retail Pharmacy Businesses Regulations 2008 to 2025 and these Regulations may be cited together as the Regulation of Retail Pharmacy Businesses Regulations 2008 to 2026.

3. These Regulations come into operation on 30 June 2026.

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

5. Regulation 5 (as amended by Regulation 3 of the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2025 ( S.I. No. 503 of 2025 )) of the Principal Regulations is amended —

(a) in subparagraph (c) of paragraph (1)—

(i) by inserting “subject to paragraph (1A),” before the word “an”;

(ii) by deleting the word “other”; and

(iii) by inserting after “maintained,” the following—

“and is kept readily available for inspection at the premises of the retail pharmacy business for a period of two years from the date on which the last entry is made in the record,”;

(b) by inserting after subparagraph (d) of paragraph (1) the following subparagraph:

“(da) the keeping of records of, and in connection with—

(i) the sale and supply of medicinal products,

(ii) the preparation and prescribing of medicinal products, and

(iii) the preparation and dispensing of prescriptions,

is subject to written procedures for managing such records,”; and

(c) by inserting after paragraph (1) the following paragraph:

“(1A) Where the record referred to in paragraph (1)(c) is maintained in an electronic format, the pharmacy owner shall verify that the computer software in use for maintaining the record ensures that—

(a) the record is subject to user access controls capable of restricting the functions that may be used; and

(b) every alteration to an entry in the record is capable of being traced by identifying the original entry, the alteration to the original entry, the identity of the person who made the alteration and the date of the alteration.”.

6. Regulation 12 (as amended by Regulation 3 of the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2025 ( S.I. No. 503 of 2025 )) of the Principal Regulations is amended —

(a) in paragraph (1)—

(i) by substituting for subparagraph (a) the following subparagraph:

“(a) such records as are prescribed, and such registers as are prescribed, under Regulations 10, 10A, 10B, 10D, 10E and 10F of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ) (as amended);”;

(ii) by substituting for subparagraph (b) the following subparagraph:

“(b) such records as are prescribed under Regulation 16, and such register as is prescribed under Regulation 19, of the Misuse of Drugs Regulations 2017 ( S.I. No. 173 of 2017 ) (as amended);”;

(iii) by substituting for subparagraph (c) the following subparagraph:

“(c) such other records in electronic form as will enable the patient in respect of whom a medicinal product has been supplied on foot of a medical prescription to be identified together with the said patient’s medication record in respect of his or her previous supplies of such products made by the pharmacy, including, where applicable, the records referred to in—

(i) Regulation 7(2A) and Regulation 10(8)(b)(i) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ) (as amended), and

(ii) Regulation 16(2B), (3A) and (8)(b) of the Misuse of Drugs Regulations 2017 ( S.I. No. 173 of 2017 ) (as amended); and”;

(b) by substituting for paragraph (2) the following paragraph:

“(2) A person carrying on a retail pharmacy business shall, in the case of records referred to in paragraph (1)(a), keep such records readily available for inspection as required under Regulation 10(3), 10A(3) and 10B(3) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ) (as amended).”;

(c) by deleting paragraph (3); and

(d) by deleting paragraph (4).

GIVEN under my Official Seal,

9 April, 2026.

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.

The purpose of these Regulations is to make provision with respect to certain retail pharmacy business records retained electronically and to make other incidental amendments.

These Regulations may be cited as the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2026.