Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015.

• Jurisdiction: Ireland
• Year: 2015
• Citation: IR SI 449/2015

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 23rd October, 2015.

I, LEO VARADKAR, 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) (No. 2) Regulations 2015.

(2) The Principal Regulations, the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 ( S.I. No. 510 of 2005 ), the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 ( S.I. No. 201 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 Regulations of 2011, the Regulations of 2014, the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2014 ( S.I. No. 504 of 2014 ), the Regulations of 2015 and these Regulations may be cited together as the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2015 and shall be construed together as one.

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 2011” means the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 ( S.I. No. 525 of 2011 );

“Regulations of 2014” means the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2014 ( S.I. No. 300 of 2014 );

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

3. Regulation 4(1) (as amended by Regulation 4 of the Regulations of 2015) of the Principal Regulations is amended—

(a) by inserting after the definition of “EEA Agreement” the following definitions:

“‘emergency’, for the purposes of Regulations 4C, 4D, 4E and 20(10) and (11), means a situation in which the physical state of an individual reasonably leads another to suspect that the first individual is experiencing a life-threatening event that requires the provision of immediate care to assist the physiological functioning of that person;

‘emergency rescue organisation’ means an organisation whose functions include provision of rescue services to persons who cannot, without specialised assistance, remove themselves from danger or entrapment, due to injury, illness or environmental conditions;”,

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

“‘listed organisation’ means an organisation or emergency rescue organisation listed in the list of organisations maintained by the Health Products Regulatory Authority pursuant to Regulation 4D(3);”,

(c) by inserting after the definition of “Opticians Board” the following definition:

“‘organisation’ includes—

(a) an organisation, body, person or group in control of a place of worship, a place of hospitality, an entertainment venue, a place of work, a sports venue, a sports club, a train station, a bus station, a ferry port, an airport or aerodrome, a commercial aircraft, a passenger ferry, a supermarket, a shopping centre, an educational establishment, a childcare facility, a crche, a museum, an art gallery, an exhibitions centre,

(b) An Garda Síochána,

(c) the Courts Service,

(d) a local authority,

(e) the Health Service Executive,

(f) a fire service,

(g) an emergency rescue organisation;”, and

(d) by substituting for the definition of “premises” the following definition:

“‘premises’ includes any aircraft, hovercraft, ship, stall, land, building or vehicle;”.

4. The Principal Regulations are amended by substituting for Regulation 4B (inserted by Regulation 4 of the Regulations of 2011) the following Regulations:

“Supply and administration of certain medicinal products by authorised persons

4B.It shall not be a contravention of a provision of these Regulations for an authorised person, in the course of his or her professional practice as an authorised person and at the premises of the retail pharmacy business in which he or she carries on that professional practice (or, in the case of epinephrine (adrenaline), glucagon, glyceryl trinitrate, naloxone or salbutamol at any place), to supply a person with, and to administer to the person, a medicinal product specified in column 1 of the Eighth Schedule if, and only if—

(a) a body recognised by the Council of the Pharmaceutical Society of Ireland has issued to the authorised person a certificate stating that he or she has satisfactorily completed a course of training approved by the Registrar of the Pharmaceutical Society of Ireland relating to the supply and administration of the product and the management of any immediate adverse reaction that may follow from such administration, and

(b) the product is administered in accordance with the requirements specified in columns 2 to 5 of the Eighth Schedule opposite the mention of the product specified in column 1 of that Schedule.

Supply and administration of medicinal products in emergencies by persons engaged or employed by listed organisations

4C.It shall not be a contravention of a provision of these Regulations for a person to supply another person with, and to administer to that person, a medicinal product specified in column 1 of the Tenth Schedule if, and only if—

(a) the medicinal product is used in an emergency,

(b) the person to whom the product is administered—

(i) has previously been prescribed the medicinal product or has been diagnosed as having the particular medical condition in respect of which the medicinal product is to be administered, provided that it is reasonable to expect this information to be obtained in the circumstances, or

(ii) where the product is a medical gas mixture consisting of 50% nitrous oxide and 50% oxygen, requires management of severe pain,

(c) the person supplying and administering the medicinal product has been issued with a certificate stating that he or she has satisfactorily completed a course of training, approved by the Pre-Hospital Emergency Care Council or another body nominated by the Minister for that purpose, in the use of the specific medicinal product, relating to the administration of the medicinal product, the management of any immediate adverse reaction that may follow from such administration, the storage and safe keeping of the medicinal product and the clinical practice guidelines and record-keeping requirements for administration of the medicinal product,

(d) the certificate certifying completion of the course of training referred to in paragraph (c) is valid for a period not longer than 2 years from the date of issuance,

(e) the product is administered in accordance with the requirements specified in columns 2 and 3 of the Tenth Schedule opposite the product listing in column 1 of that Schedule, and

(f) the person supplying and administering the medicinal product is employed or engaged by a listed organisation, or in the case of a medical gas mixture consisting of 50% nitrous oxide and 50% oxygen by a listed emergency rescue organisation, including in a voluntary capacity, and supplies and administers the medicinal product in the course of that engagement or employment.

Listed organisations

4D.(1) An organisation which wishes to procure a medicinal product specified in column 1 of the Tenth Schedule for use in emergencies, in accordance with Regulation 4C, shall notify the Health Products Regulatory Authority, prior to the first such procurement, in accordance with this Regulation.

(2) A notification under paragraph (1) shall—

(a) be made to the Health Products Regulatory Authority in such electronic form as that Authority shall accept,

(b) be accompanied by any fee which may be payable in connection with that notification,

(c) include at least the particulars listed in the Eleventh Schedule, and

(d) be made for each individual premises, should the organisation wish to procure the medicinal product for more than one premises.

(3) The Health Products Regulatory Authority shall establish and maintain a list of organisations that have provided a valid notification to it in accordance with this Regulation.

(4) The Health Products Regulatory Authority shall enter in the list referred to in paragraph (3)—

(a) the name of each organisation which has made a valid notification in accordance with this Regulation to procure a medicinal product specified in Column 1 of the Tenth Schedule,

(b) the address of the organisation by which the medicinal product shall be procured,

(c) the business name or trading style, if different to the name referred to in paragraph (a), used in connection with such procurement,

(d) the medicinal product or products in respect of which procurement has been notified,

(e) the address of the premises, which shall not be a dwelling, where the medicinal product shall be stored, and

(f) the name of the accountable person(s) pursuant to Regulation 4E.

(5) The Health Products Regulatory Authority shall publish the list referred to in paragraph (3) on its website.

(6) A listed organisation shall ensure that information provided at the time of notification under paragraph (1) remains up to date and must notify any change to that information to the Health Products Regulatory Authority within 4 weeks of that change taking place.

Accountable person in listed organisation

4E.(1) A listed organisation...