Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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articles 4

Reform history JSON API

(1) A person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is subject to general sale elsewhere than at or from a registered pharmacy unless the following conditions are met.

(2) Condition A is that the place at or from which the medicinal product is sold, supplied, or offered for sale or supply, consists of premises of which P is the occupier and which P is able to close so as to exclude the public.

(3) Condition B is that—

(a) the medicinal product was made up for sale in its immediate and outer packaging elsewhere than at the place at or from which it is sold, supplied, or offered for sale or supply; and

(b) the immediate and outer packaging has not been opened since the product was made up for sale in it.

(4) Condition C is that, if the medicinal product is of a kind specified in Schedule 15, it is presented for sale in accordance with the requirements specified in that Schedule for a product of that kind.

(5) This regulation is subject to Chapter 3.

Sale of medicinal products from automatic machines

222

A person may not sell or offer for sale a medicinal product by means of an automatic machine if the product is not subject to general sale.

CHAPTER 3 — Exemptions

Exemptions relating to supply in specific circumstances

Exemptions for doctors and dentists etc

223

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a doctor or dentist to a patient of that doctor or dentist.

(2) Regulations 220 and 221 do not apply to the sale, offer for sale, or supply of a medicinal product by a doctor or dentist—

(a) to a patient of the doctor or dentist, or

(b) to a person under whose care such a patient is.

(3) Regulations 220 and 221 do not apply to the sale, offer for sale or supply of a medicinal product in the course of the business of a hospital or health centre, where—

(a) the product is sold, offered for sale or supplied for the purposes of being administered to a person (whether in the hospital or health centre or elsewhere) in accordance with directions relating to that person; and

(b) those directions have been given by—

(i) a doctor,

(ii) a dentist,

(iii) a supplementary prescriber,

(iv) a pharmacist independent prescriber,

(v) an optometrist independent prescriber,

(vi) a nurse independent prescriber,

(vii) a community practitioner nurse prescriber,

(viii) a podiatrist independent prescriber, ...

(ix) a physiotherapist independent prescriber...

(x) a therapeutic radiographer independent prescriber, or

(xi) a paramedic independent prescriber.

(4) Regulations 220 and 221 do not apply to the sale or supply of a medicinal product to which paragraph (5) applies where—

(a) the product is sold or supplied by a registered midwife in the course of the registered midwife's professional practice; or

(b) the product is delivered or administered by a registered midwife on being supplied the product under arrangements made by the Secretary of State or the Minister for Health, Social Services and Public Safety.

(5) The products to which this paragraph applies are—

(a) medicinal products that are not prescription only medicines;

(b) prescription only medicines which by virtue of an exemption conferred under regulation 235(1) and 235(3) and Part 1 of Schedule 17 may be sold or supplied by a registered midwife otherwise than in accordance with a prescription given by a doctor or a dentist; and

(c) prescription only medicines which by virtue of an exemption conferred under regulation 235(3) and Part 3 of Schedule 17 may be administered by a registered midwife or a student midwife otherwise than in accordance with a prescription given by a doctor or a dentist.

Emergency sale etc by pharmacist: prescriber unable to provide prescription

224

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A to E are met.

(2) Condition A is that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied that the sale or supply has been requested by a relevant prescriber who by reason of an emergency is unable to provide a prescription immediately.

(3) Condition B is that the relevant prescriber has undertaken to provide the person lawfully conducting the retail pharmacy business with a prescription within the period of 72 hours beginning with the sale or supply.

(4) Condition C is that the prescription only medicine is sold or supplied in accordance with the directions of the relevant prescriber.

(5) Condition D is that the prescription only medicine is not a product subject to special medical prescription, other than a prescription only medicine that—

(a) consists of or contains phenobarbital or phenobarbital sodium; and

(b) is sold or supplied for use in the treatment of epilepsy.

(6) Condition E is that an entry is made in the record kept under regulation 253 within the time specified in that regulation stating the particulars required under paragraph 2 of Schedule 23.

Emergency sale etc by pharmacist: at patient's request

225

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A to E are met.

(2) Condition A is that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting it and is satisfied—

(a) that there is an immediate need for the prescription only medicine to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay;

(b) that treatment with the prescription only medicine has on a previous occasion been prescribed by a relevant prescriber for the person requesting it; and

(3) Condition B is that for a prescription only medicine shown in column 1 of the following table, the quantity of the product that is sold or supplied does not exceed that shown in column 2 for that prescription only medicine—

Prescription only medicine	Maximum quantity
A prescription only medicine that—ais a preparation of insulin, an aerosol for the relief of asthma, an ointment or cream, andbhas been made up for sale in a package elsewhere than at the place of sale or supply.	The smallest pack that the pharmacist has available for sale or supply.
An oral contraceptive.	A quantity sufficient for a full treatment cycle.
An antibiotic for oral administration in liquid form.	The smallest quantity that will provide a full course of treatment.
A controlled drug within the meaning of Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 or Schedule 4 or 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.	Five days' treatment.
Any other prescription only medicine.	30 days' treatment.

(4) Condition C is that the prescription only medicine—

(a) does not consist of or contain a substance specified in Schedule 18; and

(b) is not a product subject to special medical prescription, other than a prescription only medicine that—

(i) consists of or contains phenobarbital or phenobarbital sodium, and

(ii) is sold or supplied for use in the treatment of epilepsy.

(5) Condition D is that an entry is made in the record kept under regulation 253 within the time specified in that regulation stating the particulars required under paragraph 4 of Schedule 23.

(6) Condition E is that the inner or outer packaging of the prescription only medicine is labelled to show—

(a) the date on which the prescription only medicine is sold or supplied;

(b) the name, quantity and (unless apparent from the name) the pharmaceutical strength of the prescription only medicine;

(d) the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied; and

(e) the words “Emergency Supply”.

(7) In this regulation “aerosol” means a product that is dispersed from its container by a propellant gas or liquid.

Emergency sale etc by pharmacist: pandemic diseases

226

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A and B are met.

(2) Condition A is that the supply is made whilst a disease is, or in anticipation of a disease being imminently,—

(a) pandemic; and

(b) a serious risk, or potentially a serious risk, to human health.

(3) Condition B is that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied—

(a) that treatment with the prescription only medicine has on a previous occasion been prescribed by a relevant prescriber for the person to be treated with it; and

(b) as to the dose which in the circumstances it would be appropriate for that person to take.

Exemption for sale or supply in hospitals

227

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine—

(a) in the course of the business of a hospital; and

(b) for the purpose of being administered (in the hospital or elsewhere) to a particular person in accordance with directions that meet the conditions in paragraph (2).

(2) Those conditions are that the directions—

(a) are in writing;

(b) relate to the particular person to whom the prescription only medicine is to be administered; and

(3) But such directions may be given by a supplementary prescriber only where the supplementary prescriber complies with regulations 215 (prescribing and administration by supplementary prescribers) and 216 (exceptions to regulation 215) in relation to the directions as if they were a prescription.

(4) This regulation applies regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

Exemptions relating to prescriptions given by certain health professionals

228

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist where—

(a) the sale or supply is in accordance with a prescription given by a person listed in paragraph (2) who is not an appropriate practitioner in relation to that prescription only medicine; but

(b) the pharmacist, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.

(2) Those persons are—

(a) another pharmacist;

(b) a registered nurse;

(d) a person whose name is entered in the part of the Health and Care Professions Council register relating to—

(i) chiropodists and podiatrists,

(ii) physiotherapists, ...

(iii) radiographers: diagnostic or therapeutic; or

(iv) paramedics; or

(e) a registered optometrist.

(3) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist where—

(a) the sale or supply is in accordance with a prescription given by a supplementary prescriber; and

(b) the pharmacist, having exercised all due diligence, believes on reasonable grounds that the supplementary prescriber has complied with regulation 215.

Exemption for supply by national health service bodies and local authorities

229

(1) Regulations 214(1) and (2), 220 and 221 do not apply to the supply of a medicinal product in accordance with condition A or B by—

(a) the Common Services Agency;

(b) a health authority or special health authority;

(d) an NHS foundation trust;

(da) a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); ...

(db) the United Kingdom Health Security Agency;

(dc) Public Health Agency; or

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f) a person who is not a doctor, dentist or person lawfully conducting a retail pharmacy business, where the person supplies the product pursuant to an arrangement with an integrated care board, NHS England or one of the persons specified in paragraphs (a) to (dc).

(2) Condition A is that the product is supplied for the purpose of being administered to a person in accordance with the written directions of a doctor, dentist, nurse independent prescriber, optometrist independent prescriber , physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber , paramedic independent prescriber or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

(2A) In relation to a medicinal product that is for parenteral administration, condition A only applies if the person who has given the written directions is an appropriate practitioner in relation to that medicinal product.

(3) Condition B is that—

(a) the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”);

(b) the PGD relates to the supply of a description or class of medicinal product by the person by whom the medicinal product is supplied and has effect at the time at which it is supplied;

(d) the PGD is signed on behalf of the person specified in column 2 of the table in Part 2 of that Schedule (“the authorising person”) against the entry in column 1 of that table for the class of person by whom the product is supplied;

(e) the individual who supplies the product—

(i) belongs to one of the classes of individual specified in Part 4 of that Schedule, and

(ii) is designated in writing, on behalf of the authorising person, for the purpose of the supply or administration of products under the PGD; and

(f) when the product is supplied , either an authorisation by the licensing authority on a temporary basis under regulation 174 or—

(i) in Northern Ireland, a UKMA(NI), UKMA(UK)..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB), or

(ii) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exemption for supply etc under a PGD to assist doctors or dentists

230

(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product by an individual belonging to one of the classes specified in Part 4 of Schedule 16 where—

(a) the individual supplies or (as the case may be) administers the product to assist a doctor in the provision of NHS primary medical services or a dentist in the provision of NHS primary dental services;

(b) the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”); and

(2) Condition A is that the PGD relates to the supply or (as the case may be) administration of a description or class of medicinal product in order to assist the doctor or dentist in providing the services (whether or not it relates to such supply in order to assist any other doctor or dentist).

(3) Condition B is that the PGD has effect at the time at which the product is supplied or (as the case may be) administered.

(4) Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(5) Condition D is that the PGD is signed—

(a) by the doctor or dentist; or

(b) where it also relates to supply or administration to assist one or more other doctors or dentists, by one of those doctors or dentists.

(6) Condition E is that the PGD is signed—

(a) in the case of—

(i) NHS primary medical services, or

(ii) NHS primary dental services in England or Wales,

on behalf of the health authority, local authority or National Health Service Commissioning Board with which a contract or agreement for the provision of those services has been made or which provides those services;

(b) in the case of dental services in Scotland under the National Health Service (Scotland) Act 1978 , or general dental services in Northern Ireland, on behalf of the health authority with which an arrangement for the provision of those services has been made; and

(c) in the case of personal dental services provided under a pilot scheme in Scotland or Northern Ireland, on behalf of the health authority which is a party to the pilot scheme.

(7) Condition F is that the individual supplying the product is designated in writing for the purpose of the supply or (as the case may be) administration of medicinal products under the PGD—

(a) by the doctor or dentist; or

(b) where it also relates to supply to assist one or more other doctors or dentists, by one of those doctors or dentists.

(8) Condition G is that when the product is supplied or (as the case may be) administered , either an authorisation by the licensing authority on a temporary basis under regulation 174 or—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK)..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.

Exemption for supply etc under a PGD by independent hospitals etc

231

(1) Regulations 214, 220 and 221 do not apply to the sale or supply, or administration, of a medicinal product in accordance with the following conditions by—

(a) an independent hospital;

(b) an independent clinic;

(d) a nursing home (in Northern Ireland).

(2) Condition A, which applies only to England, is that the registered provider at the hospital, clinic or agency is registered in compliance with section 10 of the Health and Social Care Act 2008 in respect of one or more of the following regulated activities —

(a) treatment of disease, disorder or injury;

(b) assessment or medical treatment of persons detained under the Mental Health Act 1983;

(d) diagnostic and screening procedures;

(e) maternity and midwifery services; and

(f) family planning.

(3) Condition B is that the product is sold or supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).

(4) Condition C is that the PGD—

(a) relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person by whom the medicinal product is sold or supplied or administered; and

(b) has effect at the time at which it is sold or supplied.

(5) Condition D is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(6) Condition E is that the PGD is signed—

(a) by or on behalf of the registered provider; and

(b) if there is a relevant manager for the independent hospital, clinic or medical agency, or nursing home, by that manager.

(7) Condition F is that the individual who sells or supplies or (as the case may be) administers the product—

(a) belongs to one of the classes of individual specified in Part 4 of Schedule 16; and

(b) is designated in writing for the purpose of the sale or supply or (as the case may be) administration of products under the PGD—

(i) by or on behalf of the registered provider, or

(ii) if there is a relevant manager for the independent hospital, clinic or medical agency, or nursing home, by that manager.

(8) Condition G is that when the product is supplied , either an authorisation by the licensing authority on a temporary basis under regulation 174 or—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK)..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK) or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.

Exemption for supply etc under a PGD by independent hospitals etc

232

(1) Regulations 214, 220 and 221 do not apply to the sale or supply, or administration, of a medicinal product in accordance with the following conditions by—

(a) a dental practice in England and Wales to which paragraph (2) applies; or

(b) a dental clinic in England and Wales to which paragraph (2) applies.

(2) This paragraph applies to a dental practice or dental clinic —

(a) in England, in respect of which the registered provider is registered in compliance with section 10 of the Health and Social Care Act 2008 in respect of one or both of the following regulated activities—

(i) treatment of disease, disorder or injury, or

(ii) diagnostic and screening procedures;

(b) in Wales, in which dental services are provided by private dentists and those dentists are registered with Healthcare Inspectorate Wales in accordance with the Private Dentistry (Wales) Regulations 2008 , in relation to the services provided by those dentists.

(3) Condition A is that the product is sold or supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).

(4) Condition B is that the PGD—

(a) relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person by whom the medicinal product is sold or supplied or administered; and

(b) has effect at the time at which it is sold or supplied.

(5) Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(6) Condition D is that the PGD is signed—

(a) in England—

(i) by or on behalf of the registered provider, and

(ii) if there is a relevant manager for the practice or clinic, by that manager;

(b) in Wales—

(i) by the private dentist who is treating the person, and

(ii) if there is a manager for the practice or clinic, by that manager.

(7) Condition E is that the individual who sells or supplies or (as the case may be) administers the product—

(a) belongs to one of the classes of individual specified in Part 4 of Schedule 16; and

(b) is designated in writing for the purpose of the sale or supply or (as the case may be) administration of products under the PGD—

(i) in England—

(aa) by or on behalf of the registered provider, or

(bb) if there is a relevant manager for the practice or clinic, by that manager, or

(ii) in Wales, by the private dentist who is treating the person.

(8) Condition F is that when the product is supplied, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK) is in force in relation to it.

(9) In relation to Wales, in this regulation “manager” means—

(a) a person who carries on the dental practice or dental clinic; or

(b) if there is no such person, a person who manages the practice or clinic.

Exemption for supply etc under a PGD by dental practices and clinics: England and Wales

233

(1) Regulation 214 does not apply to the sale or supply, or administration, of a prescription only medicine by a person lawfully conducting a retail pharmacy business where—

(a) the person sells, supplies or (as the case may be) administers the prescription only medicine pursuant to an arrangement for the supply or administration of prescription only medicines with—

(i) the Common Services Agency,

(ii) a health authority or special health authority,

(iii) an NHS trust,

(iv) an NHS foundation trust,

(iva) an integrated care board,

(ivb) NHS England,

(ivc) a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006),

(ivd) the United Kingdom Health Security Agency,

(ive) Public Health Agency,

(v) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(vi) a police force in England, Wales or Scotland,

(vii) the Police Service of Northern Ireland,

(viii) a prison service,

(ix) Her Majesty's Forces, or

(x) an authority or person carrying on the business of an independent hospital, an independent clinic, an independent medical agency or, in Northern Ireland, a nursing home;

(b) the prescription only medicine is sold or supplied for the purpose of being supplied or (as the case may be) is administered to a person in accordance with a patient group direction (“PGD”); and

(2) Condition A is that the PGD relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person lawfully conducting a retail pharmacy business who sells or supplies or (as the case may be) administers the prescription only medicine.

(3) Condition B is that the PGD has effect at the time at which the prescription only medicine is sold or supplied or (as the case may be) administered.

(4) Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(5) Condition D is that the PGD is signed—

(a) in the case of an arrangement with a body referred to in paragraph (1)(a)(i) to (ive) (health bodies), by or on behalf of the person specified in column 2 of Part 2 of Schedule 16 against the entry in column 1 for that body;

(b) in the case of an arrangement with a police force in England, Wales or Scotland or with the Police Service of Northern Ireland—

(i) by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body, and

(ii) by a doctor who is not employed or engaged by, and does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland;

(c) in the case of an arrangement with a prison service, by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body;

(d) in the case of an arrangement with Her Majesty's Forces, by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for Her Majesty's Forces;

(e) in the case of an arrangement with an authority or person referred to in paragraph (1)(a)(x) (independent hospitals etc)—

(i) by or on behalf of the registered provider, and

(ii) if there is a relevant manager for the establishment or agency in question, by that manager.

(6) Condition E is that, where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business, the person belongs to one of the classes of individual specified in Part 4 of Schedule 16 and is designated in writing for the purpose of the administration of medicinal products under the PGD—

(a) in the case of an arrangement with a body referred to in paragraph (1)(a)(i) to (v) (health bodies), on behalf of that body;

(b) in the case of an arrangement with a body referred to in paragraph (1)(a)(vi) to (ix) (a police force, the Police Service of Northern Ireland, a prison service and Her Majesty's Forces), by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body; and

(c) in the case of an arrangement with an authority or person referred to in paragraph (1)(a)(x) (independent hospitals etc)—

(i) by or on behalf of the registered provider, or

(ii) if there is a relevant manager for the establishment or agency in question, by that manager.

(7) Condition F is that when the prescription only medicine is supplied or (as the case may be) administered , either an authorisation by the licensing authority on a temporary basis under regulation 174 or—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK)..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK) or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.

(8) Regulation 220 does not apply to the supply, or administration, of a prescription only medicine used for vaccination against an infectious disease where paragraph (1)(a) and (b) applies and conditions A to F are met.

(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exemption for supply etc of products under a PGD to assist the police etc

234

(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product by an individual belonging to one of the classes specified in Part 4 of Schedule 16 in accordance with the following conditions.

(2) Condition A is that the individual supplies or (as the case may be) administers the product to assist the provision of health care by, on behalf of, or under arrangements made by, one of the following bodies (“the relevant body”)—

(a) a police force in England and Wales or in Scotland;

(b) the Police Service of Northern Ireland;

(d) Her Majesty’s Forces; or

(e) a contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency.

(3) Condition B is that the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).

(4) Condition C is that the PGD relates to the supply or (as the case may be) the administration of a description or class of medicinal product to assist the provision of health care by, on behalf of, or under arrangements made by, the relevant body.

(5) Condition D is that the PGD has effect at the time at which the product is supplied or (as the case may be) administered.

(6) Condition E is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(7) Condition F is that the PGD is signed—

(a) by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for the relevant body; and

(b) where the relevant body is a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland.

(8) Condition G is that the individual who supplies the product is designated in writing by or on behalf of the relevant body for the purpose of the supply or (as the case may be) the administration of medicinal products under the PGD.

(9) Condition H is that when the product is supplied , either an authorisation by the licensing authority on a temporary basis under regulation 174 or—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK)..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.

Exemption for sale, supply or administration by certain persons

235

(1) Regulation 214(1) does not apply to the sale or supply by a person of a prescription only medicine if—

(a) the person is listed in column 1 of Part 1 of Schedule 17;

(b) the prescription only medicine is listed in the corresponding paragraph in column 2 of that Part; and

(2) Regulation 214(1) does not apply to the supply by a person of a prescription only medicine if—

(a) the person is listed in column 1 of Part 2 of Schedule 17;

(b) the prescription only medicine is listed in the corresponding paragraph in column 2 of that Part; and

(3) Regulation 214(1) does not apply to the administration by a person of a prescription only medicine if—

(a) the person is listed in column 1 of Part 3 of Schedule 17;

(b) the product is a prescription only medicine for parenteral administration listed in the corresponding paragraph in column 2 of that Part; and

(4) Regulation 220 does not apply to the sale, supply or offer for sale or supply by a person of a medicinal product if—

(a) the person is listed in column 1 of Part 4 of Schedule 17;

(b) the product is a prescription only medicine or pharmacy medicine listed in the corresponding paragraph in column 2 of that Part; and

(5) Regulation 220 does not apply to the supply by a person of a medicinal product if—

(a) the person is listed in column 1 of Part 5 of Schedule 17;

(b) the product is a prescription only medicine or pharmacy medicine listed in the corresponding paragraph in column 2 of that Part; and

(6) Regulation 221 does not apply to the sale, supply, or offer for sale or supply by a person of a medicinal product if—

(a) the person is listed in column 1 of Part 4 of Schedule 17;

(b) the product is a medicinal product subject to general sale that is listed in the corresponding paragraph in column 2 of that Part; and

(7) Regulation 221 does not apply to the sale, supply, or offer for sale or supply by a person of a medicinal product if—

(a) the person is listed in column 1 of Part 5 of Schedule 17;

(b) the product is a medicinal product subject to general sale that is listed in the corresponding paragraph in column 2 of that Part; and

(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exemptions in relation to specific kinds of product

Products consisting of or containing aloxiprin, aspirin or paracetamol

236

Regulation 214(1) does not apply to a medicinal product that is a prescription only medicine by virtue of paragraph 1(e) of Schedule 1 (non-effervescent aloxiprin, aspirin or paracetamol) if the quantity of the product sold or supplied to a person at any one time does not exceed 100 tablets or capsules.

Products consisting of or containing pseudoephedrine salts or ephedrine base or salts

237

(1) Regulation 214(1) does not apply to a medicinal product that is a prescription only medicine by virtue of paragraph 1(f) of Schedule 1 (products consisting of or containing pseudoephedrine salts or ephedrine base or salts) if conditions A and B are met.

(2) Condition A is that the product is not sold or supplied at the same time as another medicinal product that consists of or contains—

(a) in the case of pseudoephedrine salts, ephedrine base or salts; or

(b) in the case of ephedrine base or salts, pseudoephedrine salts.

(3) Condition B is that the medicinal products sold or supplied to a person at any one time do not in total contain more than—

(a) in the case of pseudoephedrine salts, 720mg pseudoephedrine salts; or

(b) in the case of ephedrine base or salts, 180mg ephedrine base or salts.

Administration of certain medicines in an emergency

238

Regulation 214(2) does not apply to the administration of a prescription only medicine specified in Schedule 19 where this is for the purpose of saving life in an emergency.

Administration of smallpox vaccine

239

(1) Regulation 214(2) does not apply to the administration of smallpox vaccine if condition A or B is met.

(2) Condition A is that—

(a) the vaccine has been supplied by, on behalf of, or under arrangements made by—

(i) the Secretary of State,

(ii) the Scottish Ministers,

(iii) the Welsh Ministers,

(iv) the Department of Health, Social Services and Public Safety, or

(v) an NHS body; and

(b) the vaccine is administered for the purpose of providing protection against smallpox virus in the event of a suspected or confirmed case of smallpox in the United Kingdom.

(3) Condition B is that—

(a) the vaccine has been supplied by, on behalf of, or under arrangements made by, Her Majesty's Forces; and

(b) the vaccine is administered for the purpose of providing protection against smallpox virus to members of Her Majesty's Forces or other persons employed or engaged by them.

Radioactive medicinal products

240

(1) Regulation 214(2) does not apply to—

(a) a radioactive substance, administration of which results in a medical exposure; or

(b) any other prescription only medicine if it is being administered in connection with a medical exposure,

if Conditions A to E are met.

(2) Condition A is that the prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to—

(a) in England and Wales and Scotland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations 2017 which apply to the exposure;

(b) in Northern Ireland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 which apply to the exposure.

(3) Condition B is that the medical exposure has been authorised by—

(a) an IRME practitioner; or

(b) where it is not practical for an IRME practitioner to authorise the exposure, an operator acting in accordance with written guidelines issued by an IRME practitioner.

(4) Condition C is that—

(a) in England and Wales and Scotland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(b) in Northern Ireland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.

(5) Condition D is that the prescription only medicine is not a product subject to special medical prescription.

(6) Condition E is that, in the case of a prescription only medicine that is not a radioactive substance, it is specified in the protocols referred to in paragraph (2).

(7) In this regulation—

“IRME practitioner” means—in relation to a medical exposure in England and Wales and Scotland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;in relation to a medical exposure in Northern Ireland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“medical exposure” has the same meaning—in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“radioactive substance” has the same meaning—in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.

Exemptions in respect of certain herbal remedies

241

(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“A”) of a herbal medicinal product if—

(a) the product does not contain a substance listed in Part 1 of Schedule 20;

(b) the product does not contain a substance listed in column 1 of Part 2 of that Schedule, unless the product is sold or supplied—

(i) in the case of a product for which there is a corresponding entry in column 2 of that Part, in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in that entry, and

(ii) in the case of a product for which there is a corresponding entry in column 3 of that Part, with the percentage of the substance in the product not exceeding that specified in that entry;

(c) the sale or supply, or offer for sale or supply, takes place on premises occupied by A and from which A can exclude the public; and

(d) the product is for administration to a person (“B”) and A has been requested by or on behalf of B and in B's presence to use A's judgment as to the treatment required.

(2) A reference in this regulation to a substance listed in either Part of Schedule 20 is a reference to a substance that is obtained from any botanical source listed in either Part.

Exemption for medicinal products at high dilution

242

(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a) the medicinal product is neither for parenteral administration nor a product subject to special medical prescription;

(b) paragraph (2) applies to the medicinal product; and

(c) P has been requested by or on behalf of a particular person and in that person's presence to use P's own judgment as to the treatment required.

(2) This paragraph applies to a medicinal product that consists solely of one or more unit preparations of—

(a) any substance where the unit preparation has been diluted to at least one part in a million (6x);

(b) any substance that is listed in Part 1 of Schedule 21 where the unit preparation has been diluted to at least one part in a thousand (3x); or

(i) is the active substance of a medicine that is subject to general sale;

(ii) is listed in Part 3 of Schedule 21; or

(iii) in the case of a medicinal product for external use only, is listed in Part 4 of Schedule 21,

where the unit preparation has been diluted to at least one part in ten (1x).

(3) Regulation 220 does not apply to the sale, supply, or offer for sale or supply by a person of a medicinal product if—

(a) the medicinal product is neither for parenteral administration nor a product subject to special medical prescription;

(b) paragraph (4) applies to the medicinal product; and

(4) This paragraph applies to a medicinal product that consists solely of one or more unit preparations of—

(a) any substance where the unit preparation has been diluted to at least one part in a million million (6c);

(b) any substance that is listed in Part 2 of Schedule 21 where the unit preparation has been diluted to at least one part in a million (6x); or

(i) is the active substance of a medicine that is subject to general sale;

(ii) is listed in Part 3 of Schedule 21; or

(iii) in the case of a medicinal product for external use only, is listed in Part 4 of Schedule 21,

where the unit preparation has been diluted to at least one part in ten (1x).

Exemption for certain homoeopathic medicinal products

243

(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a) a certificate of registration is in force in relation to the product;

(b) the product is not an excluded product; and

(c) P has been requested by or on behalf of a particular person and in that person's presence to use P's own judgment as to the treatment required.

(2) Regulation 220 does not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a) a certificate of registration is in force in relation to the product;

(b) the product is not an excluded product; and

(3) In this regulation “excluded product” means a product that is promoted, recommended or marketed—

(a) for use as an anthelmintic;

(b) for parenteral administration;

(d) for use as an eye ointment;

(e) for use as an enema;

(f) for use wholly or mainly for irrigation of wounds or of the bladder, vagina or rectum; or

(g) for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.

Other exemptions

Exemption in cases involving another's default

244

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person if the person, having exercised all due diligence, believes on reasonable grounds that the product is not a prescription only medicine.

(2) Regulation 220 does not apply to the sale or supply, or offer for sale or supply of a medicinal product by a person if—

(a) the person, having exercised all due diligence, believes on reasonable grounds that the product is subject to general sale;

(b) that belief is due to the act or default of another person; and

(c) the conditions in regulation 221 are met in relation to the sale or supply, or offer for sale or supply of the product.

Exemption in case of forged prescription

245

Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription if the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

Exemption where requirements for prescriptions not met

246

Regulation 214(1) does not apply to the sale or supply of a prescription only medicine otherwise than in accordance with a prescription given by an appropriate practitioner if—

(a) the sale or supply is otherwise than in accordance with such a prescription because a condition in regulation 217, 218, 219 or 219A is not met; and

(b) the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that the condition is met.

Exemption for supply in the event or anticipation of pandemic disease

247

(1) Regulations 214(1), 220 and 221 do not apply to the supply of a medicinal product that meets the following conditions.

(2) Condition A is that the supply is made whilst a disease is, or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk, or potentially a serious risk, to human health.

(3) Condition B is that the supply is accordance with a protocol that—

(a) is approved by the Ministers or an NHS body;

(b) specifies how the medicinal product is to be used for the prevention of or as a treatment for the disease; and

(i) the name of the person who supplies the product to the person to be treated (“the patient”) or to a person acting on the patient's behalf, and

(ii) evidence that the product was supplied to the patient or to a person acting on the patient's behalf.

(4) A function of the Ministers under this regulation may be exercised by either of them acting alone or both of them acting jointly (and the reference in this regulation to “the Ministers” is to be read accordingly).

Exemption for certain collection and delivery arrangements

248

(1) Regulations 220 and 221 do not apply to the supply of a medicinal product on premises that are not a registered pharmacy where the supply—

(a) is in accordance with a prescription issued by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber , physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber , paramedic independent prescriber or optometrist independent prescriber; and

(b) forms part of a collection and delivery arrangement used by a person who lawfully conducts a retail pharmacy business.

(2) In this regulation “collection and delivery arrangement” means an arrangement whereby a person may—

(a) take or send a prescription given by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber , physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber , paramedic independent prescriber or optometrist independent prescriber to premises other than a registered pharmacy and which are capable of being closed by the occupier to exclude the public; and

(b) collect or have collected on his or her behalf from such premises a medicinal product prepared or dispensed in accordance with such a prescription at a registered pharmacy by or under the supervision of a pharmacist or by a person who acts in accordance with regulation 220A or 220B.

CHAPTER 4 — Miscellaneous provisions, offences and disqualification

Miscellaneous provisions

Restrictions on persons to be supplied with medicinal products

249

(1) The holder of an authorisation of the kind referred to in paragraph (2) may not sell a prescription only medicine or a pharmacy medicine by way of wholesale dealing to a person who does not fall within a class specified in Schedule 22.

(2) Those authorisations are—

(a) a UK marketing authorisation;

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a certificate of registration;

(d) an Article 126a authorisation.

(3) A person may not, in the course of a business consisting (wholly or partly) of manufacturing medicinal products or of selling medicinal products by way of wholesale dealing, sell a prescription only medicine or a pharmacy medicine by way of wholesale dealing to a person who does not fall within a class specified in Schedule 22.

(4) This regulation is subject to regulation 250.

Exceptions to regulation 249

250

(1) This regulation makes provision for exceptions to regulation 249.

(2) A person may sell by way of wholesale dealing a pharmacy medicine which is for the purpose of being administered to human beings in the course of a business to any person carrying on such a business.

(3) A person may sell by way of wholesale dealing a pharmacy medicine to which a general sale exemption applies to any person who by virtue of that exemption may sell the pharmacy medicine by retail, or supply it in circumstances corresponding to retail sale, otherwise than by or under the supervision of a pharmacist or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12).

(4) In paragraph (3) “general sale exemption” means an exemption from regulation 220 conferred by a provision of Chapter 3.

(4A) A person may, in the course of a business consisting (wholly or partly) of manufacturing medicinal products or of selling products by way of wholesale dealing, sell by way of wholesale dealing a prescription only medicine to any person who by virtue of regulation 235A or 247 may supply or administer that medicine in accordance with a direction or protocol of the type mentioned in those regulations.

(4B) A person may, in the course of a business consisting (wholly or partly) of manufacturing medicinal products, or of selling products by way of wholesale dealing, sell or supply by way of wholesale dealing a naloxone product that is a prescription only medicine to—

(a) providers of drug treatment services that have arrangements as mentioned in regulation 237A(2)(a);

(b) the medical services of His Majesty’s forces;

(d) local naloxone providers.

(5) A person may sell by way of wholesale dealing to a person specified in column 1 of Parts 1 to 3 of Schedule 17 a prescription only medicine specified in relation to that person in column 2 of Parts 1 to 3 of that Schedule.

(6) A person may sell by way of wholesale dealing to a registered optometrist a product that is a prescription only medicine by reason only that it contains one or more of the following substances—

(a) amethocaine hydrochloride;

(b) lidocaine hydrochloride;

(d) proxymetacaine hydrochloride.

(7) A person may sell by way of wholesale dealing to an additional supply optometrist a product that is a prescription only medicine by reason only that it contains thymoxamine hydrochloride.

(8) A person may sell by way of wholesale dealing to a registered dispensing optician a prescription only medicine that—

(a) is required for use by a registered optometrist or doctor attending the optician's practice; and

(b) contains one or more of the following substances—

(i) amethocaine hydrochloride,

(ii) chloramphenicol,

(iii) cyclopentolate hydrochloride,

(iv) fusidic acid,

(v) lidocaine hydrochloride,

(vi) oxybuprocaine hydrochloride,

(vii) proxymetacaine hydrochloride, and

(viii) tropicamide.

(9) A person may sell by way of wholesale dealing to a registered dispensing optician a prescription only medicine that—

(a) is required for use by the optician in the course of a professional practice as a contact lens specialist; and

(b) contains one or more of the following substances—

(i) lidocaine hydrochloride,

(ii) oxybuprocaine hydrochloride, and

(iii) proxymetacaine hydrochloride.

(10) In this regulation—

“additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;

“contact lens specialist” means a person who is a registered dispensing optician and against whose name particulars of the contact lens speciality have been entered in—the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989; orthe register of visiting dispensing opticians from relevant European States maintained under section 8B(1)(b) of that Act.

Compliance with standards specified in certain publications

251

(1) A person may not sell a medicinal product that has been demanded by the purchaser by, or by express reference to, a particular name if—

(a) the name is a name at the head of the relevant monograph; and

(b) the product does not comply with the standard specified in that monograph.

(2) A person may not sell or supply a medicinal product in pursuance of a prescription given by a doctor or dentist in which the product required is described by, or by express reference to, a particular name if—

(a) the name is a name at the head of the relevant monograph; and

(b) the product does not comply with the standard specified in that monograph.

(3) A person may not sell or supply a medicinal product that has been offered or exposed for sale by, or by express reference to, a particular name if—

(a) the name is a name at the head of the relevant monograph; and

(b) the product does not comply with the standard specified in that monograph.

(4) If the particular name referred to in paragraph (1), (2) or (3) is that of an active ingredient of the product, the product does not comply with the standard specified in the relevant monograph if, in so far as it consists of that ingredient, it does not comply with that standard.

(5) See regulation 252 for the meaning of certain expressions used in this regulation.

(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—

(a) the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and

(b) the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.

(7) In paragraph (6), “relevant marketing authorisation” means—

(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or

Compliance with standards specified in certain publications: supplementary

252

(1) Where, together with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, there was specified a particular edition of a particular publication, “the relevant monograph” in that paragraph means—

(a) the monograph (if any) headed by the name in that edition; or

(b) if there is no such monograph, the appropriate current monograph (if any) headed by that name.

(2) Where, together with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, there was specified a particular publication, but not an edition of that publication, “the relevant monograph” in that paragraph means—

(a) the monograph (if any) headed by the name in the current edition; or

(b) if there is no monograph of the kind mentioned in sub-paragraph (a), the appropriate current monograph (if any) headed by that name; or

(c) if there is no monograph of the kinds mentioned in sub-paragraphs (a) or (b), the monograph headed by that name in the latest edition of the specified publication that contained a monograph headed by that name.

(3) Where no publication was specified with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, “the relevant monograph” in that paragraph means the appropriate current monograph (if any).

(4) In this regulation “publication” means—

(a) the British Pharmacopoeia; or

(b) a compendium published under Part 15 (British Pharmacopoeia).

(5) In this regulation “current” means current at the time when the medicinal product is demanded, described in a prescription or offered or exposed for sale (as the case may be).

(6) In this regulation “the appropriate current monograph”, in relation to a particular name, means—

(a) the monograph (if any) headed by that name in the current edition of the British Pharmacopoeia; or

(b) if there is no such monograph, the monograph (if any) headed by that name in the current edition of a compendium published under Part 15 (British Pharmacopoeia).

(7) For the purposes of regulation 251 and this regulation, any monograph in an edition of a publication must be construed in accordance with any general monograph or notice, or any appendix, note or other explanatory material, that is contained in that edition and applies to that monograph.

Pharmacy records

253

(1) A person lawfully conducting a retail pharmacy business must, in respect of every sale or supply of a prescription only medicine, make or cause to be made an entry in a written or computerised record kept for that purpose.

(2) An entry required by paragraph (1)—

(a) must state the particulars specified in Schedule 23; and

(b) subject to paragraph (3), must be made—

(i) on the day of the sale or supply, or

(ii) if that is not reasonably practicable, on the day following that day.

(3) Where the sale or supply is made under regulation 224 (emergency sale etc by pharmacist: prescriber unable to provide prescription), the particulars specified in paragraph 2(e) and (f) of Schedule 23 may be entered on the day that the prescription is received.

(4) Paragraphs (1) to (3) do not apply if any of the following apply—

(a) the sale or supply is in pursuance of a health prescription or a prescription for oral contraceptives;

(b) a separate record of the sale or supply is made in accordance with the Misuse of Drugs Regulations 2001 or the Misuse of Drugs Regulations (Northern Ireland) 2002;

(c) the sale is by way of wholesale dealing and the order or invoice relating to the sale or a copy of the order or invoice is retained by the person lawfully conducting the retail pharmacy business who makes the sale;

(d) in Scotland, the sale or supply is to a doctor for use in the circumstances referred to in paragraph 45 of Schedule 5 to the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 (provision of drugs, medicines and appliances for immediate treatment or personal administration);

(e) in Northern Ireland, the sale or supply is to a doctor for use in the circumstances referred to in paragraph 47 of Schedule 5 to the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 (provision of drugs, medicines and appliances for immediate treatment or personal administration).

(5) A person lawfully conducting a retail pharmacy business must preserve for a period of two years beginning immediately after the relevant date—

(a) the record kept under paragraphs (1) to (3);

(b) a prescription in pursuance of which a prescription only medicine has been sold or supplied other than—

(i) a health prescription, or

(ii) a prescription for a product subject to special medical prescription;

(d) orders referred to in column 3 of Parts 1 to 3 of Schedule 17, except orders referred to in paragraph 3 of Part 1 of that Schedule.

(6) In paragraph (5) “the relevant date” means—

(a) in relation to sub-paragraph (a), the date on which the last entry is made in the record;

(b) in relation to sub-paragraphs (b), (c) and (d)—

(i) where the prescription only medicine was sold or supplied in accordance with a repeatable prescription, the date of the final sale or supply pursuant to that prescription, and

(ii) otherwise, the date on which the prescription only medicine was sold or supplied.

Prohibitions concerning traceability of treatment with advanced therapy medicinal products

254

(1) A person may not treat a patient with an advanced therapy medicinal product if there is not a system in place for patient and product traceability in relation to such treatment containing sufficient detail to enable the linking of the product to the patient who received it and vice versa.

(2) A person may not treat a patient with an advanced therapy medicinal product if the treatment involves a product which contains human cells or tissues and the traceability system referred to in paragraph (1) is not complementary to, and compatible with, the requirements imposed pursuant to—

(a) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990;

(b) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

(3) It is a defence to an offence of breach of paragraph (1) or, as the case may be, paragraph (2) if the person who treats a patient was assured in writing before the treatment was given that a system of traceability as described in paragraph (1) or, as the case may be, paragraph (2) was in place in relation to the treatment given by that person.

(4) A person may not give an assurance in writing to a person (“P”) who treats a patient with an advanced therapy medicinal product that a system of traceability as described in paragraph (1) or paragraph (2) is in place in relation to treatment with an advanced therapy medicinal product given by P if no such system is in place.

Offences relating to dealings with medicinal products

255

(1) A person is guilty of an offence if the person breaches any of the following provisions of this Part—

(a) regulation 214(1) (prohibition on sale etc of prescription only medicine otherwise than in accordance with prescription from appropriate practitioner);

(b) regulation 214(2) (prohibition on parenteral administration of prescription only medicine otherwise than by or under directions of appropriate practitioner);

(d) regulation 249 (prohibition on sale of prescription only medicine or pharmacy medicine by way of wholesale dealing to person not within Schedule 22);

(e) regulation 251 (compliance with standards specified in certain publications); or

(f) regulation 254 (prohibitions concerning traceability of treatment with advanced therapy medicinal products).

(2) A person is guilty of an offence if the person—

(a) is an appropriate practitioner by virtue of regulation 214; and

(b) gives a prescription or directions in respect of a medicinal product in relation to which the person is not an appropriate practitioner.

(3) A person is guilty of an offence if the person gives a prescription or directions or administers a medicinal product without meeting the conditions for doing so that apply to that person by virtue of regulation 215 (conditions to be met by supplementary prescriber).

(4) A person (“P”) is guilty of an offence if—

(a) P has in P's possession a medicinal product to which regulation 214(1) applies; and

(b) P intends to supply it otherwise than in accordance with a prescription of an appropriate practitioner.

(5) A person guilty of an offence under any of paragraphs (1) to (4) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(6) A person is guilty of an offence if the person breaches—

(a) regulation 221 (prohibition on sale of medicinal product subject to general sale otherwise than in accordance with that regulation); or

(b) regulation 222 (prohibition on sale by automatic machine of medicinal product not subject to general sale).

(7) A person guilty of an offence under paragraph (6) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(8) A person is guilty of an offence if the person breaches regulation 253 (record-keeping requirements for persons carrying on a retail pharmacy business).

(9) A person guilty of an offence under paragraph (8) is liable on summary conviction to a fine not exceeding £400.

Disqualification

Disqualification on conviction

256

(1) A court before which a person (“P”) is convicted of any offence under regulation 255(8) may order that P is disqualified from using the premises where that offence was committed for a period not exceeding 2 years if the following conditions are met.

(2) Condition A is that the offence was committed in a retail pharmacy business.

(3) Condition B is that the period of disqualification relates to the future use of the premises as a retail pharmacy business.

(4) Condition C is that the enforcement authority has made an application to the court for such an order.

(5) Condition D is that the court thinks it appropriate to grant an order having regard—

(a) to the gravity of the offence of which P has been convicted as mentioned in the preceding subsection;

(b) to the unsatisfactory nature of the premises; or

(6) Condition E is that the enforcement authority has not less than 14 days before the date of the hearing given P notice in writing of their intention to apply for such an order.

(7) If P uses the premises in respect of which an order under this regulation is in force for the purposes of a retail pharmacy business, P shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(8) At any time after the end of the period of six months beginning with the date on which an order under this regulation comes into force, P may apply to the court to revoke the order or to vary it by reducing the period of disqualification.

(9) On any application made under paragraph (8) of this regulation the court may—

(a) revoke or vary the order if it thinks it proper to do so having regard to all the circumstances of the case, including in particular the conduct of the applicant and any improvement in the state of the premises to which the order relates; or

(b) refuse to revoke or vary the order.

(10) If an application made by P under paragraph (8) is refused, no further application under that paragraph may be made within the period of three months beginning with the date of the refusal.

(11) The court determining an application under this regulation shall have power to order the applicant to pay the whole or any part of the costs of the application.

(12) In the application of this regulation to Scotland, for reference to an enforcement authority and to costs there shall be substituted respectively references to the procurator fiscal and to expenses.

PART 13 — Packaging and leaflets

CHAPTER 1 Requirements for packaging and package leaflets relating to medicinal products

Packaging requirements: general

257

(1) The information specified in Part 1 of Schedule 24 must appear—

(a) on the outer packaging of a medicinal product; and

(b) on the immediate packaging of the product, unless paragraph (2) or (3) applies to the packaging.

(2) This paragraph applies to immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 1 of Schedule 24.

(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 1 of Schedule 24.

(4) The information specified in Part 2 of Schedule 24 must appear on immediate packaging to which paragraph (2) applies.

(5) The information specified in Part 3 of Schedule 24 must appear on immediate packaging to which paragraph (3) applies.

(6) Information included on the packaging of a product in accordance with this regulation, regulation 257C ..., regulation 261 and Schedule 24 must be easily legible, comprehensible and indelible.

(7) Nothing in this regulation or Schedule 24 applies to a registrable homoeopathic medicinal product.

(8) Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product ....

(9) This regulation is subject to regulation 257AA.

(10) Nothing in this regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1).

Packaging requirements: specific provisions

258

(1) In addition to other information required by this Part, the information specified in Part 1 of Schedule 25 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product sold or supplied in accordance with a prescription given by a person who is an appropriate practitioner for the purposes of regulation 214(3) to (6), whether or not the medicinal product in question is a prescription only medicine.

(2) The requirements of paragraph 4 or 6 of Schedule 25, as the case may be, are satisfied in relation to a package containing a number of packages of medicinal products of the same description if the information specified in paragraph 4 or 6 of that Schedule is shown on one or more of those packages.

(3) The information specified in Part 2 of that Schedule must appear on a package which contains a number of packages of medicinal products of the same description, other than special medicinal products, for the purpose of transport, delivery or storage.

(4) But paragraph (3) does not apply to a packing case, crate or other covering used solely for the purposes of transport or delivery of packages of medicinal products, each of which is labelled in accordance with the other requirements of this Part.

(5) In addition to the other information required by this Part, the information specified in Parts 3 and 4 of Schedule 25 must appear on the outer packaging and the immediate packaging of products of the kind specified in those Parts of that Schedule.

(6) Nothing in this regulation or Schedule 25 requires information to appear on—

(a) a package containing a medicinal product where part of the package is transparent or open, provided that the information required by this regulation and that Schedule is clearly visible through the transparent or open part of the package;

(b) a paper bag or similar wrapping in which a package that contains a medicinal product and bears information in accordance with the requirements of this regulation and that Schedule is placed at the time of sale or supply;

(d) an ampoule or other container of not more than 10 millilitres' nominal capacity which is enclosed in a package on which information appears in accordance with the requirements of this regulation and that Schedule; or

(e) a blister pack or similar packaging enclosed in a package on which information appears in accordance with the requirements of Parts 3 and 4 of Schedule 25.

(7) Nothing in this regulation or Schedule 25 applies to a medicinal product—

(a) which is an anti-viral medicine in the form of a solution to be used for the treatment of a child under the age of one year;

(b) on the container of which appears—

(i) the name of the person to whom the product is to be administered,

(ii) the date on which the product is sold or supplied, and

(iii) the necessary instructions for proper use; and

(i) a serious risk to human health, or potentially a serious risk to human health, and

(ii) pandemic or imminently pandemic.

(8) Nothing in this regulation or Schedule 25 applies to a traditional herbal medicinal product or a registrable homoeopathic medicinal product.

(9) Nothing in this regulation or Schedule 25 applies to a POC medicinal product.

259

(1) The name of a medicinal product must also be expressed in Braille format on the outer packaging of the product (or, if there is no outer packaging, on the immediate packaging of the product).

(2) The holder of a UK marketing authorisation, ..., Article 126a authorisation or traditional herbal registration for a medicinal product must ensure that the package leaflet is made available on request in formats suitable for blind and partially-sighted persons.

(3) Nothing in this regulation applies to a registrable homoeopathic medicinal product.

Package leaflets

260

(1) A package leaflet for a medicinal product must—

(a) be drawn up in accordance with the summary of the product characteristics; and

(b) contain all the information specified in Schedule 27 in the order specified in that Schedule.

(1A) If the medicinal product is an advanced therapy medicinal product ... (other than an exempt advanced therapy medicinal product), the package leaflet must contain the information specified in Part 3 of Schedule 27 in the order specified in that Part.

(2) A package leaflet must be included in the packaging of a medicinal product unless all the information required by Part 1 of Schedule 27 (and, where the product contains paracetamol, the information required by Part 2 of that Schedule) , or where the product is an advanced therapy medicinal product ..., the information specified in Part 3 of that Schedule, is conveyed on the outer packaging or the immediate packaging of the product.

(3) A package leaflet relating to a medicinal product must be legible, clear and easy to use, and the applicant for, or holder of, a UK marketing authorisation..., Article 126a authorisation or traditional herbal registration relating to the product must ensure that target patient groups are consulted in order to achieve this.

(4) Regulation (5) applies in a case where a package leaflet is not provided under paragraph (2) because all the information required by Schedule 27 is conveyed on the outer packaging or the immediate packaging of the product.

(5) Where this paragraph applies, any requirement of these Regulations that is expressed by reference to a package leaflet shall be taken to refer to the outer packaging or, as the case may be, the immediate packaging of the product.

(6) Nothing in this regulation or Schedule 27 applies to a registrable homoeopathic medicinal product.

Use of pictures and symbols etc

261

(1) The outer packaging and the package leaflet of a medicinal product may include—

(a) symbols, diagrams or pictures designed to clarify information mentioned in Part 1 of Schedule 24 or in Schedule 27; and

(b) other information, compatible with the summary of the product characteristics, which is useful to the patient.

(2) Symbols, diagrams, pictures or additional information included in accordance with this regulation must not include any element of a promotional nature.

(3) Nothing in this regulation applies to a registrable homoeopathic product.

Labelling requirements for radionuclides

262

(1) Where a medicinal product contains radionuclides—

(a) the carton and the container of the product must be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency; and

(b) the labelling on the shielding and the vial must comply with the remaining provisions of this regulation.

(2) The label on the shielding must—

(a) include the information specified in Part 1 of Schedule 24;

(b) explain in full the codings used on the vial;

(d) indicate the number of capsules or, for liquids, the number of millilitres per container.

(3) The label on the vial must include—

(a) the name or code of the medicinal product, including the name or chemical symbol of the radionuclide;

(b) the batch identification and expiry date of the product;

(d) the name and address of the manufacturer; and

(e) the amount of radioactivity; as mentioned in paragraph 2(c).

Leaflets relating to radionuclides

263

(1) The licensing authority must ensure that a detailed instruction leaflet is enclosed with—

(a) radiopharmaceuticals;

(b) radionuclide generators;

(d) radionuclide precursors.

(2) The leaflet must include the information specified in Schedule 27.

(3) The leaflet must also include—

(a) any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product; and

(b) special precautions for the disposal of the packaging and its unused contents.

Homoeopathic medicines

264

(1) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a homoeopathic medicinal product must clearly include the words “homoeopathic medicinal product”.

(2) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a registrable homoeopathic medicinal product must also include the information specified in paragraph (1) and Part 1 of Schedule 28 and no other information (unless paragraph (5) or (6) applies).

(3) Regulation (4) applies in a case where a package leaflet is not included with a registrable homoeopathic medicinal product.

(4) Unless the context requires otherwise, any requirement of these Regulations that is expressed by reference to a package leaflet shall be taken to refer to—

(a) the outer packaging or the immediate packaging of the product; or

(b) in a case to which paragraph (5) or paragraph (6) applies, the outer packaging of the product.

(5) Where the immediate packaging of a registrable homoeopathic medicinal product is in the form of a blister pack and is placed in outer packaging which complies with the requirements of this regulation and Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 2 of Schedule 28.

(6) Where the immediate packaging of a registrable homoeopathic medicinal product is too small to display the information required by Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 3 of Schedule 28.

Additional requirements for traditional herbal medicinal products

265

(1) Schedule 29 imposes additional requirements in relation to traditional herbal medicinal products.

(2) Nothing in this regulation or Schedule 29 requires information to appear on—

(a) a package containing a traditional herbal medicinal product where part of the package is transparent or open, provided that the information required by this regulation and that Schedule is clearly visible through the transparent or open part of the package;

(b) a paper bag or similar wrapping in which a package that contains a traditional herbal medicinal product and bears information in accordance with the requirements of this regulation and that Schedule is placed at the time of sale or supply;

(d) an ampoule or other container of not more than 10 millilitres' nominal capacity which is enclosed in a package on which information appears in accordance with the requirements of this regulation and that Schedule; or

(e) a blister pack or similar packaging, enclosed in a package labelled in accordance with the requirements of this regulation and that Schedule.

Language requirements etc

266

(1) Information given in accordance with the requirements of this Part must be given in English unless either or both of paragraphs (2) and (3) applies.

(2) This paragraph applies in the case of a medicinal product that has been designated as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products where—

(a) any information specified in paragraph (1) is given in a language of an EEA State other than English; and

(b) the licensing authority accedes to a reasoned request that the information need not be given in English.

(3) This paragraph applies in the case of a product for which the licensing authority grants an Article 126a authorisation where the licensing authority decides that the information need not be given in English.

(4) In a case where paragraph (5) applies, the licensing authority may grant either or both of—

(a) an exemption from the obligation that certain particulars should appear on the outer and immediate packaging and in the package leaflet of the medicinal product in accordance with this Part; and

(b) a full or partial exemption from the obligation that the information included on the outer and immediate packaging and in the package leaflet for the product must be given in English in accordance with paragraph (1).

(5) This paragraph applies—

(a) when a medicinal product is not intended to be delivered directly to the patient; or

(b) where there are severe problems in respect of the availability of the medicinal product.

(6) The licensing authority may make the grant of an exemption in accordance with paragraph (4) subject to measures that it considers necessary to safeguard human health

(7) Information given in English in accordance with this regulation may be given in several languages in addition to English, provided that the same particulars appear in all the languages used.

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