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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
diff between biosimilars and generics
biosimilars will have a unique brand name (generics don't) biosimilars not exactly same as originator, unlike generics
26
What needs to be submitted for biosimilars as part of licencing application?
‘comparability data’
27
prescribing of biologics/biosimilars
should be Rx by brand name
28
advantages of biosimilars
cheaper than originator cost savings for NHS (£200-300m/yr)
29
Who to report adverse events to biosimilars to?
MHRA - include brand name, batch no.
30
early access to medicines scheme
- 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
early access to medicines scheme - 2 parts
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
herbal meds for sale
must have a licence 1. licensed as a medicine - MA 2. Registered under the traditional herbal registration scheme - (THR)
33
requirements for THR scheme
- 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
THR scheme and Chinese medicine practitioners or herbalists compounding a medicine for an individual
THR doesn't affect these people
35
What does THR NOT apply to?
does not apply to foods, cosmetics or general consumer products
36
What requirement NOT needed for THR?
efficacy
37
THR
traditional herbal registration
38
What is pharmacovigilance?
post-marketing surveillance of the safety of medicines
39
What is pharmacovigilance focused on especially?
‘black triangle’ medicines
40
How to report adverse drug rxns?
yellow card
41
What does withdrawing a product's MA do?
removes the product from the market
42
What does black triangle mean?
indicates medicine subject to intensive monitoring
43
When is black triangle ALWAYS assigned to med?
* 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
Manufacturer’s Licence
- authorises the holder to manufacture/assemble a medicinal product (unless exemption applies)
45
What does manufacturing NOT include for ML?
- dissolving - diluting - mixing with some other substance used as a vehicle for administration
46
What does assemble mean?
enclosing a product in a container which is labelled before the product is sold or supplied OR re-labelling a product
47
What does ML describe?
describes premises, equipment, people, records and qualifications of people involved
48
What must manufacturer comply with for ML?
principles and guidelines for Good Manufacturing Practice (GMP)
49
person needed for ML
at least one ‘qualified person’ has to be nominated
50
MHRA and ML
MHRA inspectors visit to inspect premises and have powers to seize paperwork and take samples
51
Who needs wholesale dealer's licence?
required by any person who sells a medicinal product by way of wholesale dealing
52
Wholesale Dealer’s Licence?
needed to wholesale deal authorises the holder to re-sell a medicine to anyone other than the end user
53
Wholesale Dealer’s Licence?
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
records for wholesale Dealer’s Licence
records are required for medicines received and dispatched
55
recall of meds and wholesale Dealer’s Licence
licence holder must have an emergency plan for the recall of medicines
56
MHRA and wholesale dealer’s licence
MHRA visits to inspect premises
57
Does MA holder need wholesale dealer’s licence?
MA holder does not need WD sales made by a manufacturer are excluded from the definition of wholesale dealing
58
4 licensing exemptions
1. import 2. export 3. pharmacists 4. specials
59
licensing exemptions - import
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
licensing exemptions - export
- 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
products that may need licence to export
some biological products - antigens - antibodies - vaccines
62
licensing exemptions - pharmacists
* 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
Why do pharmacists have licencing exemptions?
to allow sale from a pharmacy of products without MA that either pharmacist makes themself or which they procure the manufacture
64
manufacture of products in pharmacy without MA, considerations for the product
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
licencing and med products assembled by Dr/dentist
NO licence is required if med product manufactured/ assembled by Dr/dentist and supplied to pt in course of their Tx
66
licencing and med products assembled by nurse/midwives
NO licence needed if supplied to pt in course of their Tx but ONLY for assembly
67
What does mixing mean?
the combining of two or more medicinal products together for the purposes of administering them to meet the needs of an individual pt
68
regs relating to manufacture of meds and mixing
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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