S.I. No. 139/2026 - Misuse of Drugs (Amendment) (No. 2) 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 sections 4 , 5 (amended by section 3 of the Misuse of Drugs (Amendment) Act 2016 (No. 9 of 2016)), 18 and 38 of the Misuse of Drugs Act 1977 (No. 12 of 1977) and section 5 of the Misuse of Drugs Act 1984 (No. 18 of 1984), hereby make the following regulations:

1. These Regulations may be cited as the Misuse of Drugs (Amendment) (No. 2) Regulations 2026.

2. The collective citation “the Misuse of Drugs Regulations 2017 to 2026” includes these Regulations.

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

4. In these Regulations “Principal Regulations” means the Misuse of Drugs Regulations 2017 ( S.I. No. 173 of 2017 ).

5. Regulation 2 (as amended by Regulation 3 of the Misuse of Drugs (Amendment) Regulations 2026 ( S.I. No. 9 of 2026 )) of the Principal Regulations is amended —

(a) in paragraph (1), by substituting for the definition of “registration number” the following definition:

“‘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 veterinary practitioner, the identification number issued to the veterinary practitioner for the purposes of registration under section 37 of the Veterinary Practice Act 2005 ,

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

(d) in the case of a registered dentist, the number assigned by the Dental Council to the registration in the Register of Dentists in accordance with section 26 of the Dentists Act 1985 (No. 9 of 1985), or

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

(b) in paragraph (2)—

(i) in subparagraph (a), by substituting “Subject to subparagraphs (b) and (c),” for “Subject to subparagraph (b),”; and

(ii) by inserting after subparagraph (b) the following subparagraph:

“(c) In the case of a retail pharmacy business, the register may be an electronic register which shall be based on a computerised system equivalent to the register.”.

6. Regulation 16 (as amended by Regulation 5 of the Misuse of Drugs (Amendment) Regulations 2020 ( S.I. No. 99 of 2020 )) of the Principal Regulations is amended —

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

“(2) Subject to paragraph (4), and paragraph (7) or (8), where applicable, a person dispensing a prescription for a controlled drug, other than a drug specified in Schedule 4 or 5 shall, at the time of dispensing that controlled drug—

(a) mark on the prescription the date on which the drug is dispensed,

(b) in the case of a pharmacist practising in a retail pharmacy business, mark on the prescription the registration number of the pharmacist by whom the drug was dispensed, and

(c) retain the prescription on the premises from which the drug was dispensed.”;

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

“(2A) Notwithstanding paragraph (2), where, in the case of a retail pharmacy business—

(a) a prescription for a controlled drug, other than a drug specified in Schedule 4 or 5, is transferred in electronic form via the national electronic prescription transfer system,

(b) the dispensing of the prescription has been completed by a pharmacist practising in the retail pharmacy business, and

(c) the electronic copy of the prescription is preserved in accordance with paragraph (8)(b),

the requirements of paragraph (2B) shall apply.”;

(c) by inserting after paragraph (2A) the following paragraph:

“(2B) The requirements referred to in paragraph (2A), where applicable, are that a pharmacist shall, in conjunction with the electronic copy of the prescription preserved in accordance with paragraph (8)(b), forthwith enter in a record in electronic form referred to in Regulation 12(1)(c) of the Regulation of Retail Pharmacy Businesses Regulations 2008 ( S.I. No. 488 of 2008 ) the following particulars, that is to say—

(a) the date on which the prescription was dispensed by the pharmacist, and

(b) the registration number of the pharmacist by whom the prescription was dispensed.”;

(d) in paragraph (3)—

(i) by substituting “Subject to paragraph (7) or (8), where applicable,” for “Subject to paragraph (7),”;

(ii) by substituting for clause (i) of subparagraph (c) the following clause:

“(i) forthwith record on the prescription—

(I) the quantity of each controlled drug dispensed by him or her,

(II) the date on which he or she dispensed such quantity, and

(III) his or her name and address and, in the case of a pharmacist practising in a retail pharmacy business, the registration number of the pharmacist by whom such quantity of each controlled drug was dispensed, and”;

(iii) in clause (ii) of subparagraph (c), by deleting “and”;

(iv) by inserting after subparagraph (c) the following subparagraph:

“(ca) notwithstanding subparagraph (c), where, in the case of a retail pharmacy business—

(i) the prescription is transferred in electronic form via the national electronic prescription transfer system,

(ii) the prescription is one which has been endorsed by the practitioner as one which may be dispensed on more than one occasion,

(iii) the prescription is dispensed in part by a pharmacist practising in the retail pharmacy business, and

(iv) the electronic copy of the prescription is preserved in accordance with paragraph (8)(b),

the requirements of paragraph (3A)(a) shall apply,”;

(v) by substituting for subparagraph (d) the following subparagraph:

“(d) where the dispensing of the controlled drug has been completed, the person who dispensed it shall—

(i) forthwith write or print prominently on the prescription the word ‘dispensed’ and the date on which it was dispensed,

(ii) in the case of a pharmacist practising in a retail pharmacy business, forthwith write or print prominently on the prescription the registration number of the pharmacist by whom the drug was dispensed, and

(iii) subject to paragraph (4), retain the prescription on the premises from which the drug was dispensed, and”; and

(vi) by inserting after subparagraph (d) the following subparagraph:

“(e) notwithstanding subparagraph (d), where, in the case of a retail pharmacy business—

(i) the prescription is transferred in electronic form via the national electronic prescription transfer system,

(ii) the dispensing of the controlled drug has been completed by a pharmacist practising in the retail pharmacy business, and

(iii) the electronic copy of the prescription is preserved in accordance with paragraph (8)(b),

the requirements of paragraph (3A)(b) shall apply.”;

(e) by inserting after paragraph (3) the following paragraph:

“(3A) The requirements referred to in paragraph (3)(ca) and (e), where applicable, are that a pharmacist shall, in conjunction with the electronic copy of the prescription preserved in accordance with paragraph (8)(b), forthwith enter in a record in electronic form referred to in Regulation 12(1)(c) of the Regulation of Retail Pharmacy Businesses Regulations 2008 ( S.I. No. 488 of 2008 ), the following particulars, that is to say—

(a) in the case of a prescription referred to in paragraph (3)(ca)—

(i) the quantity of each controlled drug dispensed by the pharmacist and the date on which he or she dispensed each such quantity, and

(ii) the registration number of the pharmacist by whom the controlled drug was dispensed in part, and

(b) in the case of a prescription referred to in paragraph (3)(e)—

(i) the date on which the controlled drug was dispensed by the pharmacist, and

(ii) the registration number of the pharmacist by whom the controlled drug was dispensed.”;

(f) by inserting after paragraph (7) the following paragraph—

“(8) Notwithstanding paragraph (7), in the case of a retail pharmacy business and in the case of a prescription transferred via the national electronic prescription transfer system, a person supplying a controlled drug on such prescription shall—

(a) print a copy of the prescription and the requirements of paragraphs (2), (3)(c) and (d), where applicable, shall apply in respect of that copy of the prescription as if it were the original prescription; or

(b) subject to paragraph (9), preserve an electronic copy of the prescription in a record in electronic form referred to in Regulation 12(1)(c) of the Regulation of Retail Pharmacy Businesses Regulations 2008 ( S.I. No. 488 of 2008 ) and the requirements referred to in paragraphs (2A), (3)(ca) and (e), where applicable, shall apply in respect of that electronic copy of the prescription.”; and

(g) by inserting after paragraph (8) the following paragraph—

“(9) A person carrying on a retail pharmacy business shall ensure that the electronic copy of a prescription referred to in paragraph (8)(b), where applicable, is preserved in such a manner which shall enable the ready identification of—

(a) the prescription used to authorise the dispensing of the controlled drug, or drugs, and

(b) the controlled drug, or drugs, previously dispensed under that prescription.”.

7. Regulation 19 of the Principal Regulations is amended by inserting after paragraph (5) the following paragraph —

“(6) Where a register required to be kept under this Regulation is an electronic register referred to in Regulation 2(2)(c), a person carrying on a retail pharmacy business shall verify that the computer software in use for the retention of the register ensures that—

(a) the entries in the register are subject to user access controls capable of restricting the functions that may be used;

(b) every correction to an entry in the register is capable of being traced by identifying the original entry, the correction to the original entry, the identity of the person who made the correction and the date of the correction; and

(c) every entry in the register is capable of being searched, sorted and reproduced by—

(i) the date on which the supply was received or the transaction was effected;

(ii) the name and address of the person from whom the product was obtained or to whom the product was supplied;

(iii) the authority of the person supplied to be in possession, where applicable; and

(iv) the product.”.

8. Regulation 22 of the Principal Regulations is amended by inserting after paragraph (2) the following paragraph:

“(2A) Paragraph (2) shall apply to every copy of a prescription made in pursuance of Regulation 16(8)(a) and (8)(b), where applicable.”.

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 Misuse of Drugs Regulations 2017.

The purpose of these Regulations is to make provision for certain records to be retained electronically and to further specify record-keeping requirements with respect to prescriptions transferred via the national electronic prescription transfer system.

These Regulations may be cited as the Misuse of Drugs (Amendment) (No. 2) Regulations 2026.