Brainscape's Knowledge GenomeTM

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


See full index

Law > Legislation update > Flashcards

Legislation update Flashcards

You may prefer our related Brainscape-certified flashcards:
MBE flashcards MPRE flashcards Civil Procedure 1L flashcards
1
Q

Medicinal Product (MP)

A

any substance presenting as having properties of preventing disease in humans OR substance that may be administered in humans with a view to making a diagnosis or restoring modified physiological function by exerting pharmacological/immunological/metabolic action.

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

Medicinal products does not include

A

whole blood or components there of (other than plasma prepared by industrial processes)

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

Registered Pharmacy

A

Pharmacy registered in the register kept under the Health Act

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

The Licensing Authority

A

The minister for health, social services and public safety AND/OR the secretary of stae

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

Administer

A

by injection, oral introduction to the body OR by external application

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

Healthcare Professional

A

doctor, dentist, pharmacist, pharmacy technician, nurse, midwife, optometrist, osteopath, chiropractor, other relevant registered profession (not social workers), registered dental care professional

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

Commission in Human Medicines (CHM)

A

8 minister appointed members, advice on safety, quality and efficiency of medicinal products (pharmacovigilance) and ADR

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

British Pharmacopoeia Commission (BPC)

A

8 minister appointed members that prepare the BP and list of names (headings to monographs in the BP)

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

CHM and BPC may appoint their own

A

Expert Advisory Groups (EAG)

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

License is required to

A

manufacture, import, assemble and possess for the reasons above

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

Licence is not required for

A

a nurse/pharmacist to make-up a medicine on a small scale

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

Wholesale Dealing

A

selling or supplying (or holding for this purpose) to a person who received MP with the intention of selling/supplying/administering/causing it to be administered to humans

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

Wholesale Dealing Liscence

A

Granted within 90 days of application. Valid until surrendered/revoked.

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

Notice for revoking a wholesale dealing licence

A

28 days of immediately for safety reasons

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

Requirements for Wholesale Dealing Lisence

A

appropriate staff, premises, raw materials (fridges, CD safe), informed proposed change to ‘Qualified person’, quality assurance, records, specify to whom products can be sold

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

MPs are subject to which legistaion?

A

Marketing Authorisation
Homeopathic Certificate of Registration
Traditional Herbal Registration
Article 126a Authorisation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Relevant Medicinal Product

A

MP that is not a registered homeopathic product or traditional herbal medicine

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Application for marketing authorisation takes… and is valid for…

A

210 days

5 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Application for marketing authorisation considers:

A

Max daily dose, max single dose, efficacy, positive effect vs health risk

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Expiry for marketing authorisation if product is not put on market?

A

3 years

21
Q

Classification of MPs consideres

A

max single dose, max daily dose, strength, pharmaceutical form, packaging, other circumstances

22
Q

Why classify as POM

A

dangerous to health, frequently misused, requires further investigation, prenatally administered, addictive, risk of abuse, diagnostic purposes, hospital treatment, psychotropics and narcotics

23
Q

GSL

A

can with reasonable safety be sold or supplied without the supervision of the pharmacist (dependent on pack size)

24
Q

GSL max pack size for aspirin 75mg

A

16 (or 28 EC)

25
Q

GSL max pack size for aspirin

A

30

26
Q

GSL max pack size for paracetamol

A

16 (or 30 effervescent)

27
Q

Things that will never be GSL

A

Eye-ointments, above threshold of vitamin A & D, antihelmetics (for worms), enemas

28
Q

Homeopathic products are registerable if

A

oral or external use only, no therapeutic indication appears on label/leaflet, maximum 1 part in 1000 of mother tincture

29
Q

Traditional Herbals are registerable if

A

external, oral of inhalation use, no need for medicinal monitoring

30
Q

126a authorities

A

allows certain products with no UK MA but authorised EEA to be sold for public health reasons. eg creams with no active

31
Q

Borderline substances

A

If licensing authority thinks that a product without MA is a MP. Provisional determination notice given to recipient. eg. Gluten free bread

32
Q

Exceptions

A

Certain circumstances unlicensed product may be provided. Records for 5 years. eg. pathogens, radation, toxins, chemical or biological warefare OR prescriber deems license inappropriate and so used alternative, eg melatonin

33
Q

Pharmacovigilence responsibilities of licencing authority

A

encourage reporting and facilitation of ADR including dissemination to the public. May lead to withdrawal of MP

34
Q

EEA Health Professional

A

dentist/doctor in EEA state (other than the UK & Switzerland)

35
Q

External use

A

application to the skin, teeth, oral mucosa, throat,, nose, ear, vagina or anal canal in circumstances where localised action only is necessary and systemic absorption is unlikely to occur.

36
Q

External does not inlcude

A

throat spray, nasal spray, nasal inhalation, teething preparations, throat pastillies, lozenges or nasal drops

37
Q

Patient Group Directive

A

relates to the sale of MP to the general public, signed by a prescriber and pharmacist

38
Q

POMs, unless under direction of a prescriber it is illegal to…

A

sell, supply or administer parenterally (except to self)

39
Q

Supply of GSL must be from

A

lockable premises, unopened packaging, made up elsewhere

40
Q

Supply of P medicines must be from

A

registered pharmacy, supervision of a pharmacist, person lawfully conducting a pharmacy business

41
Q

Emergency supply at prescirber request

A

No vets, no CDs except phenobarbital, Rx within 72h

42
Q

Emergency supply at the request of a patient

A

30 days worth maximum, patient must pay

43
Q

Previously pharmacists could… without a whole sale license

A

provide wholesale as long as it was a minor % of the business

44
Q

Pharmacy needs a whole sale licence unless..

A

occasional, small amount, non-profit, individuals, record 2 years

45
Q

Packaging must have

A

Braile, PIL, child resistant, paracetamol and asprin must be white tablets

46
Q

Advertising that is prohibited

A

aimed at children, unlicensed, POMs, recommendations by scientists

47
Q

Water for injection

A

can be supplied to inflate balloons or catheters, not just for injections

48
Q

Optimisation of labelling

A

pharmacists can use professional judgement to change directions on an Rx if considered to be inappropriate

Law (15 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions