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pharmacy semester 2 > lecture 1: Licenses > Flashcards

lecture 1: Licenses Flashcards

1
Q

5 types of manufacturers license?

A
  1. Manufacturer Licence (MIA)*
  2. Manufacturer ‘Specials’ Licence (MS)*
  3. Manufacturer licence for investigational medicinal products
  4. Manufacturer licence exempt advanced therapy products (Hospital exemption licence)
  5. Manufacturer licence for non-orthodox practitioners
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2
Q

do these exist for veterinary products as well?

A

yes the equivalent exists ONLY for 1 and 2

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3
Q

what does (1) a manufacturers licence allow the holder to do?

A

manufacture/ assemble licensed medicinal products- that hold a MA.
import/ export to/ from countries outside the EEA

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4
Q

define manufacture

A

any process carried out in the course of making the product

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5
Q

what does manufacture not include?

A

dissolving or dispersing the product in or diluting/ mixing it with a substance used as a vehicle for purpose of administering it

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6
Q

define assembly?

A

processes of dividing up, packaging and presentation of the product or substance

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7
Q

is assembly included in manufacture?

A

yes but still regarded as separate

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8
Q

what must the licensing authority be satisfied with before granting a licence?

A
  • operations to be carried out
  • where? premises
  • how? equipment available
  • who? staff qualifications
  • records- safekeeping
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9
Q

how long must records be retained?

A

5 years

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10
Q

do both manufacture and assembly need a manufacturers license?

A

yes

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11
Q

what does a manufacturers specials licence allow the holder to do?

A

manufacture unlicensed medicines (specials)

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12
Q

what is a special?

A

medicines that don’t have a marketing authorisation.

import unlicensed products from outside the EEA

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13
Q

do pharmacies need a specials licence to prepare specials extemporaneously?

A

no

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14
Q

what is the specials dispensing service?

A

when patients have special needs for medicines which don’t have MA.
law allows the supply and manufacture of unlicensed medicinal products (specials)

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15
Q

when can specials be dispensed in this way?

A

rare conditions/ specific circumstances which there’s clinical need for them

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16
Q

when cant specials be used in this way?

A

if there is already a licensed product for the need

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17
Q

what is needed for a pharmacist to be able to supply a special to a patient in this situation?

A

an unsolicited order by a
doctor, NIP, PIP, SP, dentist, pharmacist in hospitals, health centres, registered pharmacists.
For use by a patient under that persons direct care

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18
Q

conditions of specials:

who must the medicinal product be supplied to?

A

TO:
doctor, NIP, PIP, SP, dentist.
Or for use under pharmacist supervisionin hospitals, health centres, registered pharmacists

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19
Q

conditions of specials?

A

previous AND
no advertising
Adequate supervision and procedure for manufacture
Written records of manufacture or assembly kept- very detailed
Manufacturer MUST hold specials licence

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20
Q

who can prescribe cannabis based specials?

A

special doctors- not just any doctors.

must be registered on a specialist register

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21
Q

what license does manufacture/ assembler of cannabis based specials require?

A

specials license

home office license

22
Q

what does a ‘manufacturers license for investigational medicinal products’ allow the holder to do?

A

manufacture investigational medicinal products for use in clinical trials

23
Q

what phases on clinical trials is this licence needed for?

A

phase 1,2,3 if passed this they have an MA

24
Q

What does a wholesale dealers license allow the holder to do?

A

wholesale pharmacy, prescription only, herbals and GSL medicines

import unlicensed medicinal products from countries INSIDE the EEA

25
Q

does an equivalent exists for veterinary products?

A

no

26
Q

WL holder many distribute medicinal products only to?

A
  • Holder of a WL relating to those products
  • holder of an equivalent EEA WL
  • persons who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retain sale
  • person who may lawfully administer those products
27
Q

conditions for WL regarding handling?

A

staff, premises and equipment must be suitable for the handling and storage and distribution of the products to maintain quality

28
Q

conditions for WL regarding records?

A

records of distribution must be kept for a minimum of 5 years

29
Q

when are exemptions for MA, ML’s and WL’s applied?

A

to products prepared for an individual

for products manufactured or assembled FOR holders of authorisations

30
Q

when are pharmacists exempt from licensing requirements?

A

providing

  • activity takes place on registered premises
  • is supervised by a pharmacist
31
Q

if you are making a p or GSL product up to make something for a patient do you need a license?

A

NO as long as P or GSL and its for self administration or for someone in the customers care

32
Q

when aren’t licenses required for preparing/ dispensing a medicinal product?

A
  • a practitioners prescription
  • customers recipes AS LONG AS P or GSL!
  • counter prescribing- in accordance of pharmacists own judgement
  • assembly- as falls under manufacture
  • stock mixtures
33
Q

under the medicines act 1968, when can counter prescribing be done?

A

only for a patient present in the pharmacy at the time of the request

34
Q

what is a nostrums?

A

retail sales ‘own name’ products

35
Q

where must nostrums be prepared and under what circumstances?

A

on the premises
under pharmacist supervision
not advertised to anyone

36
Q

other practitioners exempt from licensing?

A

doctors and dentists are allowed to manufacture and assemble products intended for individual patient.
Nurses and midwives don’t need a ML to assemble (break bulk and repack) for an individual patient

37
Q

conditions of this?

A

supplied to patient in course of their treatment

- not manufactured or assembled on a large scale

38
Q

do herbal medicinal products need licenses?

A

no provided that its manufactured or assembled by a herbal practitioner
premises is lockable to the public.
the product is for administration for a present person
product doesn’t contain a listed substance

39
Q

is a ML needed to market his own products from his licensed premises?

A

no

40
Q

does group buying by retailers or practitioners require a wholesaler license? when do they?

A

no, unless the group is a separate company.

its fine if they are part of the same group

41
Q

is a WDL needed to import a product specifically for an individual?

A

no

42
Q

is a WDL needed for a product intended to be reexported without alteration?

A

no

43
Q

according to the HMR 2012 do food and cosmetics need licensing?

A

no

44
Q

what vitamins are considered food?

A 
A
B
B2
B6
C
D
E
45
Q

which cosmetics don’t need licensing?

A

external for cleansing, deodorising, caring or keeping in good condition

46
Q

which foods don’t need a license?

A

beverages, confectionary, vitamines above

47
Q

when do food and cosmetics require a license?

A
  • if promoted to practitioners
  • for oral administration with recommendation as beneficial for a particular disease or labelled with a dosage for a medicinal purpose
  • vitamins with active ingredients
48
Q

what dosage of vitamins A needs a ML?

A

> 2500 units

49
Q

what dosage of folic acid needs ML?

A

> 25ug

50
Q

what dosage of vitamin D needs ML?

A

> 250 units

51
Q

what dosage of cyanobalamin needs ML?

A

> 5ug

52
Q

no exemption on cosmetics containing?

A
  • any antibiotic
  • > 0.004% of any hormone
  • hexachlorophane except less than 0.1% and labelled with cautions
  • > 1% resorcinol

pharmacy semester 2 (15 decks)

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