Part IIIU.K. Further Provisions relating to Dealings with Medicinal Products

Modifications etc. (not altering text)

C1Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)

C2Pt. III amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)

Offences, and provision for disqualificationU.K.

[F167FSections 67A to 67D: “relevant pharmacy service”U.K.

(1)For the purposes of sections 67A to 67D a pharmacy service is a relevant pharmacy service if conditions A and B are met in respect of it.

(2)Condition A is met in respect of a pharmacy service if—

(a)the service is provided in England by a person in the course of carrying on a regulated activity in respect of which the person is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008;

(b)the service is provided in Wales—

(i)in the course of the business of a hospital,

(ii)in a prison or youth detention accommodation within the meaning of sections 185 to 187 of the Social Services and Well-being (Wales) Act 2014 (anaw 4) (see section 188 of that Act),

(iii)in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act),

(iv)by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 2 of the Care Standards Act 2000, or

(v)by a person in the course of providing a regulated service in respect of which the person is registered under Chapter 2 of Part 1 of the Regulation and Inspection of Social Care (Wales) Act 2016 (anaw 2);

(c)the service is provided in Scotland—

(i)in the course of the business of a hospital,

(ii)in a prison within the meaning of section 49C of the Criminal Law (Consolidation) (Scotland) Act 1995 (see subsection (7) of that section),

(iii)in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act),

(iv)by a person in the course of providing an independent health care service which is registered under section 10P of the National Health Service (Scotland) Act 1978, or

(v)by a person in the course of carrying on a care service which is registered under Chapter 3 of Part 5 of the Public Services Reform (Scotland) Act 2010 (asp 8); or

(d)the service is provided in Northern Ireland—

(i)in the course of the business of a hospital,

(ii)in a prison or other institution for the treatment of offenders, including a place mentioned in section 2 of the Treatment of Offenders Act (Northern Ireland) 1968 (c. 29 (N.I.)) and a juvenile justice centre within the meaning of the Criminal Justice (Children) (Northern Ireland) Order 1998 (S.I. 1998/1504 (N.I. 9)) (see Article 51(1) of that Order),

(iii)in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act), or

(iv)by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 (S.I. 2003/431 (N.I. 9)).

(3)Condition B is met in respect of a pharmacy service if it has a chief pharmacist.

(4)A chief pharmacist, in relation to a pharmacy service, is a pharmacist who—

(a)plays a significant role (irrespective of whether other individuals also do so) in—

(i)the making of decisions about how the whole or a substantial part of the activities of the pharmacy service are to be managed or organised, or

(ii)the actual managing or organising of the whole or a substantial part of those activities,

(b)has the authority to make decisions that affect the running of the pharmacy service so far as concerns the sale or supply of medicinal products, and

(c)is responsible for securing that the pharmacy service is carried on safely and effectively.

(5)For the purposes of subsection (4)(c) a pharmacy service is carried on safely and effectively if it is carried on in ways that ensure its safe and effective running so far as concerns the sale or supply of medicinal products.]

Textual Amendments