The Human Medicines (Amendment) Regulations 2019

Amendment of regulation 8 (general interpretation)

3.  In regulation 8(1)(1) at the appropriate places insert—

““care home”—

(a)

in relation to England, has the meaning given by section 3 of the Care Standards Act 2000(2);

(b)

in relation to Wales, has the meaning given by paragraph 1 of Schedule 1 to the Regulation and Inspection of Social Care (Wales) Act 2016(3);

(c)

in relation to Scotland, has the meaning given by paragraph 2 of Schedule 12 to the Public Services Reform (Scotland) Act 2010(4); and

(d)

in relation to Northern Ireland, means a nursing home as defined in article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003(5);”;

““Commission Regulation 2016/161” means Commission Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use(6);”;

““healthcare institution” has the meaning given by Article 3(2) of Commission Regulation 2016/161;”;

““hospice” means an institution whose primary function is the provision of palliative care to persons resident there who are suffering from a progressive disease in its final stages;”.

(1)

Regulation 8 was amended by S.I. 2013/1855 and 2593, 2015/1503, 2016/186, 190 and 696, 2017/715 and 2018/199.

(2)

2000 c.44; section 3 was amended by the Regulation and Inspection of Social Care (Wales) Act 2016 (2016 anaw.2) and the Health and Social Care Act 2008 (2008 c.14).

(3)

2016 anaw.2; paragraph 1 of Schedule 1 was amended by S.I. 2018/195.

(4)

2010 asp. 8

(5)

S.I. 2003/431 (N.I. 9); article 11 was amended by the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1)

(6)

OJ no. L 32, 9.2.2016, p. 1