The Human Medicines (Amendment) (No. 2) Regulations 2015

Amendment of regulation 219

4.—(1) Regulation 219(1) (electronic prescriptions) is amended as follows.

(2) In paragraph (1), for the words “product subject to special medical prescription” substitute “substance or product for the time being specified in Schedule 1 to the Misuse of Drugs Regulations 2001(2) or in Schedule 1 to the Misuse of Drugs Regulations (Northern Ireland) 2002(3)”.

(3) Omit paragraph (3).

(4) In paragraph (4)—

(a) for the words “paragraphs (2)(b) and (3)(b)” substitute “paragraph (2)(b)”;

(b) for sub-paragraphs (b) and (c) substitute—

“(b) signed with an advanced electronic signature; and

(c) sent to the person by whom it is dispensed—

(i) as an electronic communication (whether or not through one or more intermediaries), and

(ii) via the electronic prescription service, if it is for a substance or product for the time being specified in Schedule 2 or 3 to the Misuse of Drugs Regulations 2001(4) or in Schedule 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002(5).”.

(5) For paragraph (5) substitute—

“(5) In this regulation—

“advanced electronic signature” means an electronic signature that is—

(a)

uniquely linked to the person giving the prescription;

(b)

capable of identifying that person;

(c)

created using means which that person can maintain under that person’s sole control; and

(d)

linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

“electronic prescription service” means the service of that name which is managed by the Health and Social Care Information Centre established under section 252 of the Health and Social Care Act 2012(6) (the Health and Social Care Information Centre).”.

(1)

Regulation 219 was amended by S.I. 2014/490.

(2)

S.I. 2001/3998. Schedule 1 was amended by S.I. 2005/1653, 2009/3136, 2010/1144 and 1799, 2011/448, 2012/1311, 2013/176 and 625, 2014/1275, 1377 and 3277 and 2015/231.

(3)

S.R. (N.I.) 2002 No. 1. Schedule 1 was amended by S.R. 2005 No. 360, S.R. 2009 No. 390, S.R. 2010 No. 148 and 247, S.R. 2011 No. 153, S.R. 2012 No. 213, S.R. 2013 No. 78, S.R. 2014 No. 21, 158 and 261 and S.R. 2015 No. 53.

(4)

Schedule 2 was amended by S.I. 2003/1432, 2009/3136, 2011/448 and 2014/1275 and 3277. Schedule 3 was amended by S.I. 2007/2154, 2012/1311 and 2014/1275.

(5)

Schedule 2 was amended by S.R. 2003 No. 314, S.R. 2009 No. 390, S.R. 2011 No. 153, S.R. 2014 No. 158 and S.R. 2015 No. 53. Schedule 3 was amended by S.R. 2007 No. 348, S.R. 2012 No. 213 and S.R. 2014 No. 158.

(6)

2012 c. 7.