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PHAM01 > Licencing of Medicines > Flashcards

Licencing of Medicines Flashcards

1
Q

3 types of licence

A

MA - marketing authorisation

ML - manufacturer’s licence

WDL - wholesale dealer’s licence

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2
Q

2 types of certificates for clinical trials

A

CTC - Clinical Trials Certificate

CTX - Clinical Trials Exemption Certificate

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3
Q

licencing process

A
  1. clinical trials in pts - CTC/CTX
  2. assemble data about drug - MA submission

MA granted

  1. plan to produce in large batches, assemble, pack - ML submission

ML granted

  1. plan to store, distribute by wholesale - WDL submission

WDL granted

  1. marketing and distribution
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4
Q

key criteria in licencing a new med

A

safety
quality
efficacy

(** NOT cost)

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5
Q

older name for MA

A

product licence (PL)

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6
Q

What must have MA?

A

all commercially available medicinal products

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7
Q

How to check if med has MA/PL?

A

check box for ‘PL’ followed by a number

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8
Q

Who is the MA holder?

A

the manufacturer of the medicinal product

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9
Q

What does the MA authorise the holder to do?

A
  • Sell, supply or export a medicinal product
  • Procure its sale, supply or exportation
  • Procure its manufacture
  • Import it or procure its importation
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10
Q

What is needed supply medicinal product?

A

MA (unless the activity is covered by a specific exemption)

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11
Q

How long are MAs issued for?

A

usually 5 years or less

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12
Q

What happens after period of time/5yrs of having MA?

A

the MA holder must re-apply

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13
Q

Who can withdraw, amend or suspend a MA?

A

MHRA

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14
Q

How to obtain MA for medicinal product?

A
  • info on the product submitted to the MHRA
  • if new product, full info about manufacturing & testing, including clinical trial results has to be available to the MHRA
  • SPC for the product must be submitted as part of the licensing process
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15
Q

Who licences meds?

A

MHRA

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16
Q

definition of generic medicinal product

A
  • has same qualitative and quantitative composition in active substances as the reference medicinal product (RMP)
    AND
  • has same pharmaceutical form as the RMP
    AND
  • bioequivalent with the RMP demonstrated
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17
Q

When can safety and efficacy data from RMP be used for generics?

A

after a ‘data exclusivity period’ of 8 years has elapsed

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18
Q

application for safety and efficacy data from RMP for generic

A

‘abridged’ application used

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19
Q

RMP

A

reference medicinal product

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20
Q

What is a biologic?

A

medicine made from a variety of natural sources that may be human, animal or microorganism in origin

resulting in a medicine which is a biological molecule

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21
Q

What is a biosimilar?

A

a biologic medicine that is similar to an already licensed biologic medicine in terms of safety, quality and efficacy

developed and licensed to treat the same disease as the original biologic

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22
Q

What is the first biologic on the market called?

A

the originator

reference product

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23
Q

marketing of biosimilars

A

can only be marketed after the patent of the original biologic has expired

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24
Q

diff between biologic and biosimilar

A

complex structure and greater size of biologics

so can’t make an identical copy of the originator biologic

(unlike a generic medicine)

biosimilars may differ to the originator in terms of dimensions (Mr), method of synthesis, purification, stability and immunogenicity

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25
Q

diff between biosimilars and generics

A

biosimilars will have a unique brand name (generics don’t)

biosimilars not exactly same as originator, unlike generics

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26
Q

What needs to be submitted for biosimilars as part of licencing application?

A

‘comparability data’

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27
Q

prescribing of biologics/biosimilars

A

should be Rx by brand name

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28
Q

advantages of biosimilars

A

cheaper than originator

cost savings for NHS (£200-300m/yr)

29
Q

Who to report adverse events to biosimilars to?

A

MHRA

  • include brand name, batch no.
30
Q

early access to medicines scheme

A
  • enable patients to access medicines which have not obtained MA yet
  • only for meds for life-threatening/serious conditions where no suitable alternative available
31
Q

early access to medicines scheme - 2 parts

A

1) Early clinical data made available to the MHRA years before MA being applied for

2) Scientific advisers consider the benefit/risk profile of the medicine

opinion given which supports the use of the med before MA received

32
Q

herbal meds for sale

A

must have a licence

  1. licensed as a medicine - MA
  2. Registered under the traditional herbal registration scheme - (THR)
33
Q

requirements for THR scheme

A
  • quality
  • safety
  • regulated manufacturing standards
  • must provide PIL (c/i, s/e, use in children/pregnancy)
  • THR logo and THR number

** no data required on efficacy (based on ‘traditional use’)

34
Q

THR scheme and Chinese medicine practitioners or herbalists compounding a medicine for an individual

A

THR doesn’t affect these people

35
Q

What does THR NOT apply to?

A

does not apply to foods, cosmetics or general consumer products

36
Q

What requirement NOT needed for THR?

A

efficacy

37
Q

THR

A

traditional herbal registration

38
Q

What is pharmacovigilance?

A

post-marketing surveillance of the safety of medicines

39
Q

What is pharmacovigilance focused on especially?

A

‘black triangle’ medicines

40
Q

How to report adverse drug rxns?

A

yellow card

41
Q

What does withdrawing a product’s MA do?

A

removes the product from the market

42
Q

What does black triangle mean?

A

indicates medicine subject to intensive monitoring

43
Q

When is black triangle ALWAYS assigned to med?

A
  • Contains new active substance
  • Biological medicine (vaccine) or a medicine derived from plasma
  • Given a conditional approval (need to provide more data)
  • Approved under exceptional circumstances (specific reasons company can’t give comprehensive data)
  • Company marketing it required to carry out additional studies (more data on LT use, data on rare s/e seen during clinical trials)
44
Q

Manufacturer’s Licence

A
  • authorises the holder to manufacture/assemble a medicinal product
    (unless exemption applies)
45
Q

What does manufacturing NOT include for ML?

A
  • dissolving
  • diluting
  • mixing with some other substance used as a vehicle for administration
46
Q

What does assemble mean?

A

enclosing a product in a container which is labelled before the product is sold or supplied
OR
re-labelling a product

47
Q

What does ML describe?

A

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

48
Q

What must manufacturer comply with for ML?

A

principles and guidelines for Good Manufacturing Practice (GMP)

49
Q

person needed for ML

A

at least one ‘qualified person’ has to be nominated

50
Q

MHRA and ML

A

MHRA inspectors visit to inspect premises and have powers to seize paperwork and take samples

51
Q

Who needs wholesale dealer’s licence?

A

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

52
Q

Wholesale Dealer’s Licence?

A

needed to wholesale deal

authorises the holder to re-sell a medicine to anyone other than the end user

53
Q

Wholesale Dealer’s Licence?

A

needed to wholesale deal

authorises the holder to re-sell a medicine to anyone other than the end user

licence describes the premises where products are stored, distribution facilities, records and security

54
Q

records for wholesale Dealer’s Licence

A

records are required for medicines received and dispatched

55
Q

recall of meds and wholesale Dealer’s Licence

A

licence holder must have an emergency plan for the recall of medicines

56
Q

MHRA and wholesale dealer’s licence

A

MHRA visits to inspect premises

57
Q

Does MA holder need wholesale dealer’s licence?

A

MA holder does not need WD

sales made by a manufacturer are excluded from the definition of wholesale dealing

58
Q

4 licensing exemptions

A
  1. import
  2. export
  3. pharmacists
  4. specials
59
Q

licensing exemptions - import

A

no licence is required to import:
- prod for admin to the importer or a member of household (personal use)
- prod imported by Dr/dentist for admin administration to particular pt

60
Q

licensing exemptions - export

A
  • most cases, no licence is needed to export a product (except some biological products - antigens, antibodies, vaccines)
  • may be restrictions on the export of some products to other EU countries which are currently in short supply in the UK
61
Q

products that may need licence to export

A

some biological products
- antigens
- antibodies
- vaccines

62
Q

licensing exemptions - pharmacists

A
  • Pharmacists do not require licence for anything done by/under their supervision in registered pharmacy which consists of:

(a) Preparing/dispensing a med product on a Rx from practitioner

(b) Preparing/dispensing a med product to a formula provided by purchaser for admin to themself/someone in their care

(c) Preparing/dispensing a med product in the course of counter prescribing (pharmacist asked by pt to use own judgement for Tx required & pt present in the pharmacy)

(d) Preparing a stock of products for use in (a), (b), (c)

(e) Preparing stock of a med product for sale from that pharmacy, provided product not advertised (‘Chemist Nostrums’)

(f) Assembling a med product for retail sale without advertisement

(g) Wholesale dealing

63
Q

Why do pharmacists have licencing exemptions?

A

to allow sale from a pharmacy of products without MA that either pharmacist makes themself or which they procure the manufacture

64
Q

manufacture of products in pharmacy without MA, considerations for the product

A

regulations on packaging, labelling and PILs MUST be followed before supplying a med product

can make manufacture/assembly of these med products for sale impractical

65
Q

licencing and med products assembled by Dr/dentist

A

NO licence is required if med product manufactured/ assembled by Dr/dentist and supplied to pt in course of their Tx

66
Q

licencing and med products assembled by nurse/midwives

A

NO licence needed if supplied to pt in course of their Tx

but ONLY for assembly

67
Q

What does mixing mean?

A

the combining of two or more medicinal products together for the purposes of administering them to meet the needs of an individual pt

68
Q

regs relating to manufacture of meds and mixing

A

regulations affecting the manufacturing of medicines DO NOT apply to the mixing of medicines by an appropriate practitioner if the mixing of medicines forms part of a CMP for an individual patient

DO NOT APPLY also if acting in accordance with a written direction of an app practitioner if the mixing of medicines forms part of a CMP for an individual pt

PHAM01 (22 decks)

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