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PHA221 > The licensing system > Flashcards

The licensing system Flashcards

1
Q

What are the different types of licences?

A
  • Marketing authorisation
  • Manufacturer’s licence
  • Wholesale dealer’s licence
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2
Q

What are the 2 types of certificates?

A
  • Clinical trials certificate

- Clinical trials exemption certificate

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3
Q

Outline the licensing process

A

Clinical trials ( CTC/CTX) ->

Assemble drug properties/formulation data (MA) ->

Plan to produce in large batches, assemble + pack (ML) ->

Plan to store + distribute product by wholesale (WDL) ->

Marketing + distribution

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4
Q

What are the key criteria in licensing a new medicine?

A
  • Safety
  • Quality
  • Efficacy
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5
Q

What is the other name for a marketing authorisation?

A

Product licence

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6
Q

Which products need a marketing authorisation?

A

All commercially available medicinal products

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7
Q

A MA authorises the holder to what?

A
  • Sell, supply + export product
  • Procure sale, supply + exportation
  • Procure manufacture
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8
Q

Is it lawful to supply/manufacture a medicinal product without an MA?

A

No

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9
Q

How long is a MA issued?

A

5 years

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10
Q

After 5 years, MA holders must do what?

A

Apply for licence renewal

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11
Q

Which organisation has power to withdraw or amend a MA?

A

MHRA

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12
Q

What must be submitted in order to obtain a MA for a medicinal product? And to who?

A
  • Info on product

- MHRA

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13
Q

What happens when a product is new and must obtain an MA?

A
  • Full info about manufacturing + testing
  • Clinical trials result available to MHRA
  • Summary of product characteristics submitted
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14
Q

What is a manufacturer’s licence?

A
  • Authorises holder to manufacture or assemble medicinal product
  • Describes premises, equipment, people, record + qualifications of people involved
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15
Q

In a manufacturer’s licence, what does ‘manufacture’ not include?

A

Doesn’t include dissolving, diluting or mixing

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16
Q

Define assemble

A

Enclosing a product in a container which is labelled before the product is sold or supplied, or re-labelling a product

17
Q

In the manufacturer’s licence, what must the manufacturer comply with?

A

Principles for good manufacturing practice

18
Q

Who requires a wholesale dealer’s licence?

A

Any person who sells a medicinal product by way of wholesale dealing

19
Q

What does a wholesale dealer’s licence authorise?

A

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

20
Q

Does an MA holder require a wholesale dealer’s licence?

A

No

21
Q

Outline the requirements for a wholesale dealer’s licence?

A
  • Records for medicines received + dispatched
  • Emergency plan for recall of medicines
  • MHRA visits to inspect premises
22
Q

Outline the licensing exemptions when importing medicinal products

A
  • Product for administration to importer or member of household
  • Product imported by doc/dentist for admin to particular patient
23
Q

Most cases require no license for the export of a product. Which products require a licence?

A

Biological products:

  • Antigens
  • Antibodies
  • Vaccines
24
Q

Pharmacists don’t require a licence when under the supervision of a pharmacists in a registered pharmacy which consists of…

A
  • Preparing/dispensing product on prescription of practitioner
  • Preparing/dispensing product to formula provided by purchaser for administration
  • Preparing/dispensing product in course of counter prescribing
  • Preparing stock that is not advertised
  • Assembling product for retail sale w/o advertisement
25
Q

What are specials?

A
  • Unlicensed products prepared by Special’s licence holder
  • Made on the order of doc, dentist, nurse prescriber, pharmacist prescriber
  • For patient they’re treating
26
Q

What are the requirements of a specials manufacturer?

A
  • Holds specials manufacturer’s licence
  • Not advertise/solicits orders for products
  • Carry manufacture under certain conditions
  • Maintain written record
27
Q

How long is a specials record kept at a pharmacy and what must it include?

A
  • 5 years
  • Patient details
  • Name + quantity
  • Who manufactured it
  • Batch no.
  • Date supplied
28
Q

Any adverse drug reaction to a special must be reported to who?

A

MHRA via yellow card scheme

29
Q

Does an unlicensed medicine have an MA?

A

No

30
Q

Why are extemporaneous medicines classed as specials?

A

Because they are unlicensed

31
Q

When should unlicensed medicines be prescribed?

A

If no equivalent licensed product exists

32
Q

What are the requirements when prescribing + dispensing an unlicensed medicine?

A
  • Ensure prescriber realise med is unlicensed + inform prescriber of suitable licensed alternative
  • Patients informed med is unlicensed
33
Q

What is unlicensed use?

A

Prescribing of a licensed medicine outside its license

34
Q

What may unlicensed use be due to?

A
  • Dose
  • Age
  • Route of admin
  • Indication
35
Q

What are the requirements when prescribing + dispensing an unlicensed use of product?

A
  • Ensure prescriber is aware of the unlicensed use of a product + inform prescriber of suitable licensed alternative
  • Patient informed of unlicensed use + what this means
36
Q

Herbal medicines which are for sale to public must have which licenses?

A
  • Licensed as medicine

- Registered under traditional herbal registration scheme

37
Q

What does the traditional herbal registration scheme ensure?

A
  • Quality
  • Safety
  • Regulated manufacturing standards
  • No data required on efficacy
  • Must provide patient w/ PIL
  • THR logo + no.

PHA221 (22 decks)

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