2015 No. 903

Medicines

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

Made

Laid before Parliament

Coming into force

The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in the exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 19721, having been designated for the purposes of section 2(2) of that Act in relation to medicinal products2.

Citation and commencement1

These Regulations may be cited as the Human Medicines (Amendment) (No. 2) Regulations 2015 and shall come into force on 1st July 2015.

Amendment of the Human Medicines Regulations 20122

The Human Medicines Regulations 20123 are amended in accordance with regulations 3 to 8.

Amendment of regulation 2183

In regulation 2184 (requirements for prescriptions: EEA health professionals), in paragraph (8), for the words “219 (electronic prescriptions)” substitute “219A (electronic prescriptions: EEA health professionals)”.

Amendment of regulation 2194

1

Regulation 2195 (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 20016 or in Schedule 1 to the Misuse of Drugs Regulations (Northern Ireland) 20027”.

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 20018 or in Schedule 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 20029.

5

For paragraph (5) substitute—

5

In this regulation—

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

    1. a

      uniquely linked to the person giving the prescription;

    2. b

      capable of identifying that person;

    3. c

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

    4. 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 201210 (the Health and Social Care Information Centre).

Insertion of regulation 219A5

After regulation 219 (electronic prescriptions) insert—

Electronic Prescriptions: EEA health professionals219A

1

This regulation applies to a prescription that is not a health prescription for a product subject to special medical prescription.

2

A prescription only medicine is also sold or supplied in accordance with a prescription given by an EEA health professional if—

a

conditions B and C in regulation 218 are not met; but

b

the conditions in paragraph (3) of this regulation and conditions A and D to F in regulation 218 are met.

3

The conditions mentioned in paragraph (2)(b) are that the prescription is—

a

created in electronic form;

b

signed with an electronic signature; and

c

sent to the person by whom it is dispensed as an electronic communication (whether or not through one or more intermediaries).

Amendment of regulation 2466

In regulation 246 (exemption where requirements for prescriptions not met), in sub-paragraph (a), for the words “or 219” substitute “, 219 or 219A”.

Amendment of regulation 2697

In regulation 269 (offences relating to packaging and package leaflets: other persons), in paragraph (1), after the words “in the course of a business” insert “carried on by that person,”.

Amendment of regulation 3468

In regulation 34611 (Secretary of State to carry out a review of certain provisions), in paragraph (2), for paragraph (xxviiie)12 substitute—

xxviiie

219 and 219A,

Signed by the authority of the Secretary of State.

Earl HoweParliamentary Under-Secretary of StateDepartment of Health
Jim WellsMinister for Health, Social Services and Public Safety
EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Human Medicines Regulations 2012, which sets out the requirements in respect of the manufacture, distribution, sale and supply (amongst other things) of medicines for human use in the United Kingdom.

Regulation 4 amends regulation 219 of the 2012 Regulations in order to allow appropriate practitioners other than EEA health professionals to use electronic prescriptions for a product specified in Schedule 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002, provided these are sent via the Electronic Prescription Service.

Regulations 3, 5 and 6 are required to preserve the current arrangements for electronic prescriptions given by an EEA health professional.

Regulation 7 corrects an error in regulation 269 of the 2012 Regulations by adding in words that were included in the equivalent provision of the Medicines Act 1968 (c. 67), which the 2012 Regulations replaced.

Regulation 8 amends regulation 346 of the 2012 Regulations to ensure that the new provisions relating to electronic prescriptions are subject to review by the Secretary of State.

A full impact assessment has not been produced for this instrument as no adverse impact on private, public or voluntary sectors is foreseen.