Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011

• Jurisdiction: Ireland
• Citation: IR SI 525/2011
• Year: 2011

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 18th October, 2011.

I, JAMES REILLY, 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), make the following regulations:

1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011.

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

3. Regulation 4(1) of the Principal Regulations is amended by inserting the following definitions:

“ ‘pharmacy owner’ and ‘retail pharmacy business’ shall have the meanings they have in the Pharmacy Act 2007 (No. 20 of 2007);”.

4. The Principal Regulations are amended by inserting the following after Regulation 4A:

“Supply and administration of influenza vaccine, etc., 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), 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 Council relating to the administration of the product and the management of any 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.”.

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

“(6) Paragraph (1) shall not apply as respects a medicinal product specified in column 1 of the Eighth Schedule in any case where it is to be, and is, administered by an authorised person pursuant to Regulation 4B.”.

6. The Principal Regulations are amended by inserting the following after Regulation 10:

“Keeping of records in relation to supply and administration of influenza vaccine, etc.

10A.(1) Subject to paragraph (4), an authorised person who administers a medicinal product pursuant to Regulation 4B shall make an entry, in a register kept for the purpose by the pharmacy owner (who may be that authorised person) at the premises of the retail pharmacy business in which the authorised person carries on his or her professional practice as an...