Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

pha108 > Human Medicines Regulations > Flashcards

Human Medicines Regulations Flashcards

1
Q

HMR 214

A

(1) A person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.

(2) A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person is—

(a)an appropriate practitioner other than an EEA health professional; or

(b)acting in accordance with the directions of such an appropriate practitioner.

(3) The following are appropriate practitioners in relation to any prescription only medicine—

(a)a doctor;

(b)a dentist;

(c)a supplementary prescriber;

(d)a nurse independent prescriber; and

(e)a pharmacist independent prescriber.

(4) A community practitioner nurse prescriber is an appropriate practitioner in relation to a prescription only medicine specified in Schedule 13.

(5) An optometrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine other than—

(a)a medicinal product that is a controlled drug; or

(b)a medicinal product that is for parenteral administration.

(6) An EEA health professional is an appropriate practitioner in relation to any prescription only medicine other than a controlled drug.

(7) This regulation is subject to Chapter 3 (exemptions).

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

HMR 215

A

subscribing and administration by a supplementary prescriber

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

HMR 217

A

requirements for prescriptions : general

For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner unless the following conditions are met.

(2) Condition A is that the prescription is signed in ink by the appropriate practitioner giving it.

(3) Condition B is that the prescription—

(a)is written in ink or otherwise so as to be indelible; or

(b)in the case of a health prescription which is not for a controlled drug, is written as described in sub-paragraph (a) or by means of carbon paper or similar material.

(4) Condition C is that the prescription contains the following particulars—

(a)the address of the appropriate practitioner giving it;

(b)the appropriate date;

(c)an indication of the kind of appropriate practitioner giving it;

(d)the name and address of the person for whose treatment it is given; and

(e)if that person is under 12, that person’s age.

(5) Condition D is that the prescription—

(a)is not dispensed after the end of the period of six months beginning with the appropriate date; or

(b)in the case of a repeatable prescription—

(i)it is not dispensed for the first time after the end of that period, and

(ii)it is dispensed in accordance with the directions contained in the prescription.

(6) Condition E is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a)it is not dispensed on more than two occasions, or

(b)in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the appropriate date.

(7) In this regulation “appropriate date” means, subject to paragraph (8)—

(a)in the case of a health prescription, whichever is the later of—

(i)the date on which it was signed by the appropriate practitioner giving it, or

(ii)a date indicated by the appropriate practitioner as the date before which it should not be dispensed; and

(b)otherwise, the date on which the prescription was signed by the appropriate practitioner giving it.

(8) This regulation—

(a)does not apply to a prescription given by an EEA health professional (as to which see regulation 218); and

(b)is subject to regulation 219 (electronic prescriptions).

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

HMR 218

A

requirements for prescriptions by an EEA health professional

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

HMR 219

A

electronic prescriptions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

HMR220

A

sale or supply of products that are not 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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

HMR 221

A

sale and supply of medicines that are subject to GSL

(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 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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

HMR 222

A

sale from automatic machines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

HMR 223

A

exemptions for doctors and dentists
(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, or

(vii)a community practitioner nurse 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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

HMR 229

A

exemptions by NHS bodies

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

HMR 230

A

exemptions for sale and supply under a pgd

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

HMR 231

A

exemptions for sale and supply under a PGD by a private hospital

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

HMR 232

A

exemptions for sale and supply under a PGD by dental practices and clinics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

HMR 233

A

exemptions for supply under a PGD by pharmacy business owners

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

HMR 234

A

exemptions for sale and supply under a PGD to help the police

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

HMR 236

A

products consisting of aloxiprin , aspirin or paracetamol

17
Q

HMR 237

A

products consisting or containing of pseudoephedrine and ephedrine

18
Q

HMR 260

A

leaflets

19
Q

HMR 261

A

use of pictures and symbols

20
Q

HMR 264

A

Homeopathic medicines

21
Q

HMR 279

A

products without a marketing authorisation

22
Q

HMR 281

A

duties of authorised holders and registered holders

23
Q

HMR 283

A

products with the purpose of inducing an abortion
A person may not publish an advertisement that is likely to lead to the use of a medicinal product for the purpose of inducing an abortion.

24
Q

HMR 287

A

material about the effects of medicinal products

(1) A person may not publish an advertisement relating to a medicinal product that suggests that the effects of taking the medicinal product—

(a)are guaranteed;

(b)are better than or equivalent to those of another identifiable treatment or medicinal product; or

(c)are not accompanied by any adverse reaction.

(2) A person may not publish an advertisement relating to a medicinal product that uses in terms that are misleading or likely to cause alarm pictorial representations of—

(a)changes in the human body caused by disease or injury; or

(b)the action of the medicinal product on the human body.

(3) A person may not publish an advertisement relating to a medicinal product that refers in terms that are misleading or likely to cause alarm to claims of recovery.

(4) A person may not publish an advertisement relating to a medicinal product that suggests that—

(a)the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product; or

(b)the health of a person could be affected by not taking the medicinal product.

(5) Paragraph (4)(b) is subject to [F1regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

25
Q

HMR 289

A

recommendations by scientists etc

A person may not publish an advertisement relating to a medicinal product that refers to a recommendation by—

(a)scientists;

(b)health care professionals; or

(c)persons who because of their celebrity could encourage use of the medicinal product

26
Q

HMR 292

A

exception for approved vaccination campaign

pha108 (14 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions