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LAW EXAM > s2 w1 > Flashcards

s2 w1 Flashcards

Labelling RMP Manufacturing and Wholesale Advertising

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1
Q

what legislations underpin labelling of medicines?

A

• Human Medicines Regulations 2012
– Part 13. Packaging and Leaflets
– Schedule 24. Packaging information requirements
– Schedule 25. Packaging requirements: specific provisions
• NB. Those medicinal products that are CDs must also be labelled in accordance with the Misuse of Drugs Regulations 2001

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2
Q

what are the requirements for labelling of medicinal prodcts?

A

All labelling of containers and packages of RMP shall be:
i. Easily legible
ii. Comprehensible
iii. Indelible
Either in English only or in English and one or more other languages, provided same particulars appear in all languages

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3
Q

You need to express Braile on outer packaging

A

TRUE

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4
Q

what is needed on the immediate outer packaging?

A
  1. Name
  2. Strength
  3. who intended for
  4. active substance (if more then 3 - common name)
  5. pharmaceutical form
  6. method of admin
  7. warnings
  8. expiry
  9. storage
  10. MA name and address of holder
  11. batch number
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5
Q

Will POM be in a POM rectangle

A

TRUE

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6
Q

what is INN?

A

International non-proprietary name

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7
Q

a blister pack need all the outer packaging requirements?

A

FALSE

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8
Q

what does a blister pack need on it?

A
  1. Name of product
  2. Strength and form
  3. Intended for babies, children or adults
  4. common name of each active substance
  5. name of MA holder
  6. expiry date
  7. batch number
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9
Q

you need to state contains paracetamol

A

TRUE

- unless it is in the name of the product

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10
Q

what are the four types of manufacturing licenses?

A
  1. Manufacturer licence (MIA)
  2. Manufacturer Specials License
  3. Manufacturer licence for investigational medicinal products
  4. Manufacturer licence exempt advanced therapy products (Hospital exemption licence)
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11
Q

what does a manufacturer licence allow holder to do?

A

– Manufacture and/or assemble licensed medicinal products, including export to a country outside the EEA
– Import licensed medicinal products from countries outside the EEA

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12
Q

manufacturing with a manufacturing licence include dissolving or dispersing the product in, or diluting or mixing it with, a substance used as a vehicle for purpose of administering it

A

FALSE

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13
Q

what is involved in assembly with manufacturing licence

A

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

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14
Q

what MUST licensing authority be satisfied with to grant a licence?

A
  1. What: Operations which will be carried out
  2. Where: Premises
  3. How: Equipment available
  4. Who: Qualifications of supervisory staff
  5. Records: Arrangements for safekeeping and maintenance of adequate records
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15
Q

before a product can be manufactured what must it be?

A

covered by marketing authorisation, held by the manufacturer or by a person ordering the product from a manufacturer.

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16
Q

what does a manufacturers special licence allow holder to do?

A
  • Manufacture unlicensed medicines ‘specials’

* Import unlicensed medicinal products from outside the EEA

17
Q

what is special dispensing sevice?

A

allows patient who may have special clinical needs which may not be met by licensed medicinal product

18
Q

who is allowed to manufacture a special medicinal product?

A

– doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber
– Pharmacists in hospitals, health centres, registered pharmacies

19
Q

what are the conditions for manufacturing special medicinal product?

A

A. Medicinal product is supplied—
a) to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or
b) for use under the supervision of a pharmacist in
centre
B. No advertising
C. Adequate supervision & procedure for manufacture
a) to meet specified requirements
D. Written records of manufacture or assembly kept
a) Available for inspection
E. Manufacturer holds Manufacturer ‘Specials’ Licence

20
Q

what must m• Manufacturer or assembler of ‘specials’ hold?

A

– Manufacturers (Specials) Licence
– Home Office Licence (in most cases)
– Comply with requirements of BP – pharmaceutical preparations

21
Q

what is a wholesale dealer licence (WDL)?

A

WDL allows holder to:
• wholesale pharmacy, prescription only, traditional herbal and GSL medicines
• import unlicensed medicinal products from countries inside the EEA

22
Q

what can a WDL distrubte medicinal product to?

A

a) holder of a WL relating to those products;
b) holder of an equivalent EEA WL;
c) person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale; or
d) a person who may lawfully administer those products

23
Q

what are the exemptions to licensing?

A
  • Medicinal products specially prepared for an individual

* Products manufactured (or assembled) for holders of authorisations

24
Q

when are pharmacists exempt from licensing?

A
  • activity takes place on registered pharmacy premises (hospitals and care homes)
  • is supervised by a pharmacist
25
Q

when are licences NOT required for dispensing and preparing of medicinal products?

A

a) Practitioner’s prescription
b) Customer’s recipes/ specifications where product is for self-administration or for someone in customers’ care
c) Counter prescribing
d) Assembly
e) Stock mixtures

26
Q

Herbalist need a license?

A

FALSE

provided that the product was made by a herbal practitioner and does not contain certain listed substances.

27
Q

what are exemptions for wholesale dealing licence?

A

• A manufacturer or MA holder does not need a wholesale dealer licence to market his own products directly from his licensed premises

28
Q

what are exemptions for imports and exports of WDL?

A

– to import a product specifically for an individual

– for a product intended to be re-exported without alteration

29
Q

borderline substances need a MA?

A

TRUE

- if promoted to practitioners

30
Q

what is defintion of advertisement?

A

includes

  • door to door
  • visits by medical sales reps
  • supply of samples
  • sponsorship
31
Q

what includes in advertising/

A
  • Medical journals
  • Magazines
  • Newspapers
  • Notices/posters
  • TV or radio
  • Internet advertising
  • Films/ cine recordings
  • Circular or personal letters
  • Posters in London underground trains
32
Q

MHRA handles complaints of advertising

A

TRUE

LAW EXAM (8 decks)

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