Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020

• Jurisdiction: Ireland
• Citation: IR SI 98/2020
• Year: 2020

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 10th April, 2020.

I, SIMON HARRIS, Minister for Health, in exercise of the powers conferred on me by section 32 (as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) 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) Regulations 2020.

(2) The Principal Regulations, the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 ( S.I. No. 510 of 2005 ), the Regulations of 2007, Part 4 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008 ( S.I. No. 512 of 2008 ), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009 ( S.I. No. 442 of 2009 ), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 ( S.I. No. 525 of 2011 ), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2014 ( S.I. No. 300 of 2014 ), the Regulations of 2014, the Regulations of 2015, the Regulations (No. 2) of 2015, the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2018 ( S.I. No. 530 of 2018 ) and these Regulations may be cited together as the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2020.

2. In these Regulations—

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

“Regulations of 2007” means the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 ( S.I. No. 201 of 2007 );

“Regulations of 2014” means the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2014 ( S.I. No. 504 of 2014 );

“Regulations of 2015” means the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015 ( S.I. No. 87 of 2015 );

“Regulations (No. 2) of 2015” means the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015 ( S.I. No. 449 of 2015 ).

3. Regulation 4(1) (as amended by Regulation 3 of the Regulations (No. 2) of 2015) of the Principal Regulations is amended—

(a) by inserting after the definition of “controlled drug” the following definition:

“‘Covid-19 emergency’ means the situation resulting from the spread in the State of the disease caused by infection with the virus SARS-CoV-2, being a disease specified as an infectious disease in accordance with Regulation 6 of, and the Schedule to, the Infectious Diseases Regulations 1981 ( S.I. No. 390 of 1981 ), or any variant of the disease so specified as an infectious disease in those Regulations;”,

(b) by inserting after the definition of “the Minister” the following definition:

“‘national electronic prescription transfer system’ means a system providing for the transfer of prescriptions, in permanent and unalterable form, by electronic means approved, on behalf of the Health Service Executive, by the head of the Primary Care Reimbursement Service (PCRS) and the Chief Information Officer;”, and

(c) by inserting after the definition of “product authorisation” 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), or

(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 ;”.

4. Regulation 7 (as amended by Regulation 4 of the Regulations of 2014) of the Principal Regulations is amended—

(a) in paragraph (1), by substituting for subparagraph (a) the following:

“(a) be in—

(i) nk and be signed by the person issuing it with his or her usual signature and be dated by him or her, or

(ii) electronic form, transmitted by the national electronic prescription transfer system and clearly indicate the date of issuance and, without prejudice to subparagraph (c)(ii), the professional registration number of the person issuing it, and must be traceable electronically back to him or her;”,

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

“(2A) Notwithstanding the provisions of paragraph (2), in the circumstances arising from the Covid-19 emergency, the following provisions shall apply to the dispensing of a...