Medicinal Products (Safety Features On Packaging) Regulations 2019.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: (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”.
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paragraphs: These Regulations come into operation on 9 February 2019.
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paragraphs: (1) In these 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.
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paragraphs: (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 is the Authority.
(2) The competent authorities in the State for the purposes of Articles 31(2), 32(4), 35(1)(e), 36(j) and 37(f) and (g) of the EU Regulation are the Authority and the Society.
(3) The Authority and the Society may exchange and share information and data in carrying out their duties as competent authorities under the EU Regulation.
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paragraphs: (1) This Regulation applies to—
(a) medicinal products subject to prescription other than those listed in Annex I to the EU Regulation, and
(b) medicinal products which are not subject to prescription and are listed in Annex II to the EU Regulation.
(2) Subject to paragraph (3), a wholesaler shall verify and decommission the unique identifier of a medicinal product before he or she supplies that product to any of the following persons or institutions:
(a) persons authorised to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;
(b) a veterinary practitioner, as defined in section 2(1) of the Veterinary Practice Act 2005 (No. 22 of 2005);
(c) retailers of veterinary medicinal products;
(d) registered dentist, as defined in section 2 of the Dentists Act 1985 (No. 9 of 1985);
(e) persons registered with the Optical Registration Board under the Health and Social Care Professionals Act 2005 (No. 27 of 2005);
(f) paramedics and emergency medical practitioners;
(g) the Defence Forces, An Garda S[html]och[html]na and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;
(h) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions;
(i) prisons;
(j) schools;
(k) hospices;
(l) nursing homes.
(3) Paragraph (2) shall not apply where, before the wholesaler supplies the medicinal product, the person or institution to be supplied informs the wholesaler that such person or institution will verify and decommission the unique identifier before supplying the product to the public.
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paragraphs: The Control of Placing on the Market Regulations are amended—
(a) in Regulation 3(1) (as amended by Regulation 3 of the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2018), by inserting after the definition of “Regulation (EC) No. 726/2004” the following definition:
“‘Regulation (EU) 2016/161’ means Commission Delegated Regulation (EU) 2016/161 of 2 October 2015;”, and
(b) in Regulation 17 (inserted by Regulation 6 of the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013)—
(i) in paragraph (1), by inserting “, in accordance with Regulation (EU) 2016/161,” after “safety features”,
(ii) in paragraph (2), by inserting “, in accordance with Regulation (EU) 2016/161,” after “device”, and
(iii) in paragraph (3), by substituting for subparagraphs (b) and (c) the following:
“(b) medicinal products subject to prescription which are listed in Annex I to Regulation (EU) 2016/161, and
(c) medicinal products which are not subject to prescription and are not listed in Annex II to the Regulation (EU) 2016/161.”.
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paragraphs: The Control of Wholesale Distribution Regulations are amended—
(a) in Regulation 4(1) (as amended by Regulation 3(g) of the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013)—
(i) by substituting for the definition of “safety features” the following:
“‘safety features’ means the unique identifier and anti-tampering device required to be affixed on the packaging of a medicinal product under Regulation (EU) 2016/161;”, and
(ii) by inserting after the definition of “Regulation (EC) No. 726/2004” the following definition:
“‘Regulation (EU) 2016/161’ means Commission Delegated Regulation (EU) 2016/161 of 2 October 2015;”, and