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MO1 > licensing > Flashcards

licensing Flashcards

1
Q

what is the licensing system?

A

was the main novel feature of the MA 1968 (now controlled by HMR 2012) and remains at the centre of all control over medicines

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2
Q

what are the 3 types of license?

A

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

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3
Q

what are the two types of certificate?

A
  • Clinical Trials Certificate (CTC)
  • Clinical Trials Exemption Certificate (CTX)
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4
Q

what do licences and certificates permit?

A

a person or company to engage in specific,
controlled activities. Companies may therefore need more than one licence to
carry out a process

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5
Q

what happens if you preform an activity without a lic/ cert?

A

it is an offence

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6
Q

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

A

safety
quality
efficacy

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7
Q

what is MA?

A

All commercially available medicinal products must have a marketing authorisation (MA) - Formerly known as ‘product licences’ (PL)

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8
Q

who is the MA holder?

A

The manufacturer of the medicinal product is usually the MA holder

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9
Q

what does the MA auhorise 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

how long are MA issued for?

A

issued for a period of time (usually 5 years or less) and may have certain restrictions attached
* After this period the MA holder must re-apply
* MHRA has power to withdraw, amend or suspend a MA

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11
Q

how do you obtain MA?

A

info has to be submitted to MHRA
If it is a new product, full information about manufacturing and testing,
including clinical trial results has to be made available to the MHRA
* A Summary of Product Characteristics (SPC) for the product must be
submitted as part of the licensing process

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12
Q

when is a product defined as a generic product?

A
  • It has the same qualitative and quantitative composition in active substances as the reference medicinal product (RMP) and
  • It has the same pharmaceutical form as the RMP and
  • Bioequivalence with the RMP has been demonstrated
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13
Q

when can safety and efficacy date be used from the RMP?

A

after a ‘data exclusivity period’ has elapsed
* Data exclusivity period is 8 years

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14
Q

what is the difference between a biologic and a biosimilar?

A

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

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15
Q

what must manufacturers of biosimilars submit for MA?

A

must submit ‘comparability data’ as part of the
licensing application

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16
Q

what is the early access to medicines scheme?

A
  • Aim is to enable patients to access medicines which have not yet obtained a MA
  • Only used for medicines used for life-threatening or seriously debilitating conditions and where no suitable alternative is available
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17
Q

what are the two parts of the early access to medicines scheme?

A

1) Early clinical data is made available to the MHRA several years prior to a MA being formally applied for
* 2) Scientific advisers consider the benefit/risk profile of the medicine

18
Q

should herbal medicines have a licnece?

A
  • Herbal medicines which are for sale to the public must have a licence
  • Licensed as a medicine (i.e., MA) or
  • Registered under the traditional herbal registration (THR) scheme
19
Q

what does the THR scheme cover?

A
  • Quality
  • Safety
  • Regulated manufacturing standards
  • No data required on efficacy – based on ‘traditional use’
  • Must provide the patient with a PIL (c/i, s/e, use in children/pregnancy
    etc)
  • THR logo and THR number
20
Q

what is the purpose of black triangle medicines?

A

A black triangle is used to indicated the medicine is subject to intensive monitoring
* ‘Black triangles’ now appear in patient information leaflet

21
Q

when is a black triangle status assigned?

A
  • new active substance
    -biological med
  • conditional approbal
    -approved under exceptional circumstances
  • company carrying out additional studies
22
Q

who requires a wholesale dealers licence?

A

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

23
Q

what does a wholesale dealers licence allow?

A

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

24
Q

what does a wholesale dealers license describe?

A

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

25
Q

what are the licencing exemptions surrounding importation?

A

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

26
Q

what are the licensing exemptions surrounding export?

A

In most cases no licence is required to export a product (except some biological products e.g. antigens, antibodies, vaccines)
* Note that there may be restrictions on the export of some products to other EU countries which are currently in short supply in the UK

27
Q

when do pharmacists not require a licence?

A

(a) Preparing or dispensing a medicinal product on a prescription given by a practitioner
(b) Preparing or dispensing a medicinal product to a formula provided by the purchaser for administration to himself or to somebody in
his care
(c) Preparing or dispensing a medicinal product in the course of counter prescribing. i.e. where pharmacist has been asked by a patient to use his own judgement as to the treatment required and the patient is present in the pharmacy at the time
(d) Preparing a stock of products for use in (a), (b) or (c)
(e) Preparing a stock of a medicinal product for sale from that pharmacy, provided the product is not advertised (‘Chemist Nostrums’)
(f) Assembling a medicinal product for retail sale without advertisement from that pharmacy or another forming part of the same retail pharmacy business
(g) Wholesale dealing

28
Q

is a license required for assembly?

A
  • No licence is required where a medicinal product is manufactured or assembled by a doctor or dentist and is supplied to a patient in the course of their treatment
  • The medicinal product must not be manufactured or assembled on a large scale or by an industrial process
  • The same applies to nurses and midwives for assembly only
29
Q

do regulations for manufacturing apply to mixing?

A

do not apply to the mixing of medicines by an appropriate practitioner if the mixing of medicines forms part of a clinical management plan for an individual patient

30
Q

what are the two uses of unlicensed medicines?

A
  • Use of an unlicensed product
  • Use of a licensed product for an unlicensed use (also known as ‘off label use’)
31
Q

what is the difference between an unlicensed product and unlicensed use?

A
  • An unlicensed product has no MA and it does not have a SPC. It does not have a monograph in the BNF
  • Unlicensed use of a licensed medicinal product – the medicine is licensed but the indication it is being prescribed for is not. This unlicensed use may or may not be listed or
    mentioned in the BNF monograph for the licensed product
32
Q

when should unlicensed meds be given?

A
  • Unlicensed medicines should only be prescribed or dispensed if no equivalent licensed product exists
33
Q

what are specials?

A

‘Specials’ are unlicensed medicinal products prepared by a Special’s Licence holder that are made on the order of a doctor, dentist, nurse
independent prescriber, pharmacist independent prescriber or supplementary prescriber for use by their patients

34
Q

what does the manufacturer have to do for specials?

A
  • Hold a specials manufacturer’s licence
  • May 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
35
Q

how long after should a record be kept for specials?

A

5 years- regarding patient, name and quantity of product, who manufactured it, batch number, date supplied to patient

36
Q

how should adverse drug reactions be reported to MHRA?

A

yellow card scheme

37
Q

what is the guidance for pharmacies preparing unlicensed medicines?

A
  • the one-off preparation of an unlicensed medicine in accordance with a prescription for an individual patient
  • the preparation of a stock of unlicensed medicines, (in anticipation of a prescription), which will later be supplied from the pharmacy, by or under the supervision of a pharmacist, against a prescription for an individual patient
  • the preparation of methadone for supply in accordance with a prescription (either for immediate supply in accordance with the prescription, or initially as stock to be supplied from the pharmacy, by or under the supervision of a pharmacist, against a prescription at a later time)
  • the preparation of an unlicensed medicine based upon the pharmacist’s judgement (Chemist’s Nostrum)
  • the preparation of an unlicensed medicine by, or under the supervision of, a pharmacist based on the specification of the patient
38
Q

how may a drug be unlicnesed?

A
  • Dose
  • Age (especially children)
  • Route
  • Indication
39
Q

what are parallel imported medicines?

A

Parallel imports (PIs) are medicines imported from another country which are a version of one already available in the UK which has a UK marketing authorisation

40
Q

what qualities should PIs have?

A

The country must be on the approved country for imports list. Initially, countries in the EEA are the only countries included on this list
* The product must -have a MA from the country of manufacture
* The product must have no different therapeutic effect from the product
covered by the UK MA
* Products need a UK MA but, instead of full MA with all data from clinical trials etc. being submitted, an application for a product licence (parallel import) –PL(PI) can be made instead

41
Q

what is a counterfit medicine?

A

A medicine which is deliberately and fraudulently mislabelled with respect to identity or source

42
Q

what are the different types of counterfit medicines?

A
  • Illegally labelled authentic product
  • Relabelled expired product
  • Generic medicine packaged as branded medicine
  • Sub-standard ‘copy’
  • Product containing no active ingredient
  • Product containing toxic ingredient

MO1 (50 decks)

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