Brainscape's Knowledge GenomeTM

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


See full index

PHA 221 > the licensing system > Flashcards

the licensing system Flashcards

1
Q

what is the licensing system

A

Licensing system was the main novel feature of the Medicines Act (now replaced by the HMR 2012) and remains at the centre of all control over medicines

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

what are the 3 types of licenses you can get?

A

Marketing Authorisation (MA)
•Manufacturer’s Licence (ML)
•Wholesale Dealer’s Licence (WDL)

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

what are the 2 types of certificates you can get?

A
  • Clinical Trials Certificate (CTC)

* Clinical Trials Exemption Certificate (CTX)

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

true or false- it is an offence to preform any of these without a license

A

true

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

what are the 3 key criteria in licensing a new medicine?

A

safety
quality
efficacy

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

what was the marketing authorization formally known as?

A

product license (PL)

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

what must all commercially available products have?

A

a marketing authorization -MA

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

Who is usually the MA holder?

A

the manufacture of the medicinal product

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

what does the MA allow the holder to do?

A
  • Sell, supply or export a medicinal product
  • Procure its sale, supply or exportation
  • Procure its manufacture
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

how long are MAs usually issued for?

A

5 years

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

what does the MHRA have the power to do to an MA?

A

withdraw or ammend it

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

what does the manufactures license allow?

A

Authorises the holder to manufacture or assemble a medicinal product (unless an exemption applies)

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

what does the manufactures license not allow them to do?

A

Manufacture does not include dissolving, diluting or mixing with some other substance used as a vehicle for administration

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

what is assembled defined as?

A

Assemble is defined as “enclosing a product in a container which is labelled before the product is sold or supplied, or simply re-labelling a product”

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

what does the MA describe?

A

Licence describes premises, equipment, people, records and qualifications of people involved

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

what is a wholesalers license?

A

Required by any person who sells a medicinal product by way of wholesale dealing

17
Q

what must a wholsaler have an emergency plan for?

A

the recall of medicines

18
Q

do you need a license to import?

A

No license is required to import:
•A product for administration to the importer or a member of his household (i.e. for personal use)
•A product imported by a doctor or dentist for administration to a particular patient

19
Q

in what cases do you need a license to export?

A

(except some biological products e.g. antigens, antibodies, vaccines

20
Q

do pharmacists need a license?

A

Pharmacists do not require a license for anything done by or under the supervision of a pharmacist in a registered pharmacy

21
Q

are specials licensed?

A

all specials are unlicensed

22
Q

what must the specials manufacturer have?

A
  • Hold a “specials” manufacturer’s licence
  • Not advertise or solicit orders for the product
  • Carry out the manufacture under certain conditions to ensure the quality of the product
  • Maintain written records
23
Q

what is an unlicensed medicine?

A

An unlicensed medicine has no MA and it does not have a SPC. It does not have a monograph in the BNF
•All extemporaneous medicines are unlicensed and so are ‘specials’

24
Q

when should unlicensed medicines be prescribed?

A

when there is no licensed form- patient should be infomred

25
Q

how are all ADRs to unlicensed medicines recorded?

A

on a yellow card

26
Q

what is unlicensed off-label use?

A
  • This is prescribing of a licensed medicineoutside of its license (i.e. outside of what is specified in the SPC) –don’t confuse with unlicensed medicine
  • Unlicensed use may be due to
  • Dose (high/low/different dose frequency or time)
  • Age (especially in children)
  • Route of administration
  • Indication
27
Q

who takes responsibility for off labeled use?

A

The prescriber takes the clinical and legal responsibility for the prescribing i.e. the product liability passes from the manufacturer to the prescriber

28
Q

how are herbal medicines classified?

A
  • Licensed as a medicine (i.e. MA) or

* Registered under the traditional herbal registration (THR) scheme

29
Q

what is the differneces in classification of herbal medicines?

A

•No data required on efficacy –based on ‘traditional use’

PHA 221 (19 decks)

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