Medicinal Products (Safety Features On Packaging) Regulations 2019

• Jurisdiction: Ireland
• Citation: IR SI 36/2019
• Year: 2019

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” 15th of February, 2019

I, SIMON HARRIS, 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 purpose of giving effect to Commission Delegated Regulation (EU) 2016/161 of 2 October 20151 , hereby make the following regulations:

Citation

1. (1) These Regulations may be cited as the Medicinal Products (Safety Features on Packaging) Regulations 2019.

(2) The Control of Placing on the Market Regulations, the Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2009 ( S.I. No. 3 of 2009 ), the Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) (No. 2) Regulations 2009 ( S.I. No. 553 of 2009 ), the Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2010 (No. 287 of 2010), the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2011 ( S.I. No. 722 of 2011 ), the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 ( S.I. No. 272 of 2012 ), the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 ( S.I. No. 162 of 2013 ), the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2014 ( S.I. No. 151 of 2014 ), the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2018 (S.I. No. 529 of 2018) and Regulation 6 may be cited together as “the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2019”.

(3) The Control of Wholesale Distribution Regulations, the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2009 ( S.I. No. 2 of 2009 ), the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2010 ( S.I. No. 286 of 2010 ), the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 ( S.I. No. 274 of 2012 ), the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 ( S.I. No. 164 of 2013 ) and Regulation 7 may be cited together as “the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2019”.

(4) The Control of Manufacture Regulations, the Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2009 ( S.I. No. 4 of 2009 ), the Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2010 ( S.I. No. 288 of 2010 ), the Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2012 ( S.I. No. 273 of 2012 ), the Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 ( S.I. No. 163 of 2013 ) and Regulation 8 may be cited together as “the Medicinal Products (Control of Manufacture) Regulations 2007 to 2019”.

Commencement

2. These Regulations come into operation on 9 February 2019.

Interpretation

3. (1) In these Regulations—

“Authority” means the Health Products Regulatory Authority;

“Control of Manufacture Regulations” means the Medicinal Products (Control of Manufacture) Regulations 2007 ( S.I. No. 539 of 2007 );

“Control of Placing on the Market Regulations” means the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 );

“Control of Wholesale Distribution Regulations” means the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 ( S.I. No. 538 of 2007 );

“Directive” means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20012 , as amended from time to time;

“EU Regulation” means Commission Delegated Regulation (EU) 2016/161 of 2 October 20151 ;

“health centre” means a health centre under the management or control of a hospital;

“healthcare institution” means a hospital, in patient or out patient clinic or health centre;

“in patient or out patient clinic” means an in patient or out patient, or day patient, clinic under the management or control of a hospital;

“packaging” means outer packaging or, in the case of a medicinal product with no outer packaging, the immediate packaging;

“Society” means the Pharmaceutical Society of Ireland;

“unique identifier” means the unique identifier required to be placed on the packaging of medicinal products under the EU Regulation;

“wholesaler” means the holder of a wholesaler’s authorisation, as defined in Regulation 4(1) of the Control of Wholesale Distribution Regulations and, for the avoidance of doubt, does not include a pharmacist supplying medicinal products pursuant to Regulation 6(c) of those Regulations.

(2) A word or expression that is used in these Regulations and is also used in the EU Regulation or the Directive has, unless the context otherwise requires, the same meaning in these Regulations that it has in the EU Regulation or the Directive.

Competent authorities under EU Regulation

4. (1) The competent authority in the State for the purposes of Articles 18, 22(d), 24, 25(4)(b), 30, 35(1)(i)(ii), 36(i) and (m), 37(a), (d), and (e), 39, 43, 44 and 46 of the EU Regulation...