Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 26th February, 2016.

I, KATHLEEN LYNCH, Minister of State at the Department of Health, in exercise of the powers conferred on me by section 18 (1) of the Pharmacy Act 2007 (No. 20 of 2007) (as adapted by the Health and Children (Alteration of Name of Department and Title of Minister) Order 2011 ( S.I. No. 219 of 2011 )) and the Health (Delegation of Ministerial Functions) Order 2014 ( S.I. No. 532 of 2014 ), hereby make the following regulations:

1. (1) These Regulations may be cited as the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2016.

(2) The Principal Regulations and these Regulations may be cited together as the Regulation of Retail Pharmacy Businesses Regulations 2008 and 2016 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 ).

3. The Principal Regulations are amended—

(a) in Regulation 5(1), by inserting after sub-paragraph (e) the following subparagraph:

“(ea) medicinal products other than medicinal products referred to in sub-paragraph (e), and not being medicinal products on a general sales list, are stored in a part of the premises to which the public does not have access,”, and

(b) in Regulation 15(a), by substituting “5(1)(c), (e) and (ea)” for “5(1)(c)”.

GIVEN under my Hand

22 February 2016.

KATHLEEN LYNCH,

Minister of State at the Department of 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 to require pharmacy owners and superintendent pharmacists to store medicinal products, which are not prescription medication or schedule 5 controlled drugs or medicines listed on a general sales list, to be stored in a part of the pharmacy premises to which the public does not have access.

These Regulations also amend the Regulations of 2008 to provide that this requirement, along with the requirement to ensure that prescription medication and schedule 5 controlled drugs are not accessible to the public for self-selection, are relevant provisions for the purpose of section 18 (3) of the Pharmacy Act 2007 .

These Regulations may be cited as the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2016.