Exemptions Flashcards
Human medicines regulation 220
sale or supply of medicinal products that are not subject to general sale
(1) unless paragraph (2) applies , a person (p) may not sell or supply or offer for sale or supply a medicinal product that is not subject to general sale
(2) this paragraph applies if
(a) P is a person lawfully conducting a retail pharmacy business
(b) the product is sold , supplied or offered for sale or supply on premises that are a registered pharmacy ; and
(c) p. or, if the transaction is carried out on P’s behalf by another person , that other person is, or acts under the supervision of a pharmacist
(3) this regulation is subject to chapter 3
Human medicines regulation 221
(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 a registered pharmacy unless the following conditions are met.
(2) condition A is that the place at 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 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 king 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
Human medicines regulation 227
(1) regulation 214 does not apply ro the sale or supply of a pom-
(a) in the course of the business of a hospital and
(b) for the purpose of being administered 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 pom is to be administered
(c) are given by a person who is an appropriate practitioner in relation to that pom
(3) but such directions may be given by a supplementary prescriber only where the supplementary prescriber complies with regulations 215 and 216 in relation to the directions as if they where a prescription
(4) this regulation applies regardless of whether the directions comply with regulation 217
MEP-PGD
allows the supply and or administration of a specific medicine or medicines by named authorised health professionals to a well defined group of patients requiring treatment for a specific condition
should be limited situations where there is an advantage for patient care
HMR:229 supply by nhs bodies
(1) Regulations 214(1), 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;
(c)an NHS trust;
(d)an NHS foundation trust;
(e)a Primary Care Trust; or
(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 one of the persons specified in paragraphs (a) to (e).
(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 or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).
(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;
(c)the PGD contains the particulars specified in Part 1 of Schedule 16;
(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, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in relation to it.
HMR 230- exemption for supply etc under a PGD to assist doctors or dentists
(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
(c)the following conditions are met.
(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 or Primary Care Trust 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(1), 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, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in relation to it.
HMR 231- exemption for supply etc under a PGD by independent hospitals etc
(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;
(c)an independent medical agency; or
(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(1) in respect of one or more of the following regulated activities(2)—
(a)treatment of disease, disorder or injury;
(b)assessment or medical treatment of persons detained under the Mental Health Act 1983;
(c)surgical procedures;
(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, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in relation to it.
HMR 232 - exemption for supply etc under a PGD by dental practices and clinics : England and Wales
(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(1), 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 marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration 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.
HMR 233 - exemption for supply etc under a PGD by person conducting a retail pharmacy business
(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,
(v)a Primary Care Trust,
(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
(c)the following conditions are met.
(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 (v) (health bodies), on behalf of 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, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in relation to it.
HMR 234 - exemption for supply etc of products under a PGD to assist the police etc
(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;
(c)a prison service; or
(d)Her Majesty’s Forces.
(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, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in relation to it.
PGD – Schedule 16 (4 parts)
Part 1: What should be included
Part 2: Who should sign the PGD depending on who is supplying (NHS bodies).
Part 3: Who should sign if being supplied by the police/prison/army
Part 4: Who can supply
PGD – Schedule 16
The period during which the direction is to have effect.
The description or class of medicinal product to which the direction relates.
The clinical situations which medicinal products of that description or class may be used to treat or manage in any form.
Whether there are any restrictions on the quantity of medicinal product that may be sold or supplied on any one occasion and, if so, what restrictions.
The clinical criteria under which a person is to be eligible for treatment.
Whether any class of person is excluded from treatment under the direction and, if so, what class of person.
Whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances.
The pharmaceutical form or forms in which medicinal products of that description or class are to be administered.
The strength, or maximum strength, at which medicinal products of that description or class are to be administered.
The applicable dosage or maximum dosage
The route of administration.
The frequency of administration.
Any minimum or maximum period of administration applicable to medicinal products of that description or class.
Whether there are any relevant warnings to note and, if so, what warnings.
Whether there is any follow up action to be taken in any circumstances and, if so, what action and in what circumstances.
Arrangements for referral for medical advice.
Details of the records to be kept of the supply, or the administration, of products under the direction.
Who can supply a PGD?
Pharmacists.
Registered chiropodists and podiatrists.
Registered dental hygienist.
Registered dental therapist.
Registered dietitians.
Registered midwives.
Registered nurses.
Registered occupational therapists.
Schedule 17 of HMR
Divided into 5 parts:
Sale and Supply of POM’s
Supply of POM’s
Administration of POM’s
For certain persons who sell, supply or offer for sale or supply certain medicinal products
For certain persons who supply certain medicinal products
Midwives
(a) Adrenaline,
(b) Anti-D immunoglobulin,
(c) Carboprost,
(d) Cyclizine lactate,
(e) Diamorphine,
(f) Ergometrine maleate,
(g) Gelofusine,
(h) Hartmann’s solution,
(i) Hepatitis B vaccine,
(j) Hepatitis immunoglobulin
Lidocaine hydrochloride,
(l) Morphine,
(m) Naloxone hydrochloride,
(n) Oxytocins, natural and
synthetic,
(o) Pethidine hydrochloride,
(p) Phytomenadione,
(q) Prochlorperazine,
(r) Sodium chloride 0.9%
