Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012

• Jurisdiction: Ireland
• Citation: IR SI 274/2012
• Year: 2012

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 27th July, 2012.

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), for the purpose of giving further effect to Directive 2008/29/EC of the European Parliament and of the Council of 11 March 20081 , Directive 2009/53/EC of the European Parliament and of the Council of 18 June 20092 and Directive 2010/84/EU of the European Parliament and of the Council of 15 December 20103 , hereby make the following regulations:

1. These Regulations may be cited as the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012.

2. In these Regulations “Principal Regulations” means the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 ( S.I. No. 538 of 2007 ).

3. Regulation 4(1) (as amended by the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2010 ( S.I. No. 286 of 2010 )) of the Principal Regulations is amended—

(a) by substituting for the definition of “Act” the following:

“‘Act’ means the Irish Medicines Board Act 1995 (No. 29 of 1995), as amended by s. 197 of the Finance Act 1999 (No. 2 of 1999), Regulation 3 of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 ( S.I. No. 444 of 2001 ), Regulation 3 of the European Communities (Medical Devices) (Amendment) Regulations 2002 ( S.I. No. 576 of 2002 ), the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) and the European Communities (Amendment of the Irish Medicines Board Act 1995 ) Regulations 2007 ( S.I. No. 542 of 2007 );”,

(b) by inserting after the definition of “advanced therapy regulation” the following definition:

“‘Agency’ means the European Medicines Agency established by Article 55 of Regulation (EC) No. 726/2004/EC of the European Parliament and of the Council of 31 March 20044 ;”, and

(c) by substituting for the definition of “2001 Directive” the following:

“‘2001 Directive’ means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20015 , as amended by Directive 2002/98/EC of the European Parliament...