Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations 2014

• Jurisdiction: Ireland
• Citation: IR SI 504/2014
• Year: 2014

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 7th November, 2014.

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) and for the purposes of giving further effect to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 20111 and giving effect to Commission Implementing Directive 2012/52/EU of 20 December 20122 , 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 2014.

(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 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 ) and these Regulations may be cited together as the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2014 and shall be construed 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 ).

3. Regulation 4(1) (as amended by Regulation 3 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011) of the Principal Regulations is amended—

(a) by inserting after the definition of “authorised person” the following definition:

“‘biological medicinal product’ means a product, the active substance of which is a biological substance as described in Part 1 of Annex 1 to the 2001 Directive;”,

(b) by inserting after the definition of “clinical practice guidelines” the following definition:

“‘common name’ means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name;”,

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

“‘2001 Directive’ means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20012, as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 20033 , Commission Directive 2003/63/EC of 25 June 20034 , Directive 2004/24/EC of the European Parliament and of the Council of 31 March 20045 , Directive 2004/27/EC of the European Parliament and of the Council of 31 March 20046 , Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 20067 , Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 20078 , Directive 2008/29/EC of the European Parliament and of the Council of 11 March 20089 , Directive 2009/53/EC of the European Parliament and of the Council of 18 June 200910 , Commission Directive 2009/120/EC of 14 September 200911 , Directive 2010/84/EU of the European Parliament and of the Council of 15 December 201012 , Directive 2011/62/EU of the European Parliament and of the Council of 8 June 201113 and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 201214 ;”,

(d) by inserting after the definition of “dosage unit” the following definitions:

“‘EEA Agreement’ means the Agreement on the European Economic Area signed in Oporto on 2 May 1992 as adjusted by the Protocol to that Agreement done at Brussels on 17 March 1993;

‘EEA state’ means a state, which is a contracting party to the EEA Agreement;

‘European Economic Area’ means the European Economic Area created by the EEA Agreement;”,

(e) by inserting after the definition of “maximum strength” or “MS” the following definition:

“‘medicinal product subject to special medical prescription’ means a medicinal product which is subject to the prescription writing requirements specified in Article 13 of the Misuse of Drugs Regulations 1988 ( S.I. No. 328 of 1988 );”

(f) by substituting for the definition...