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Law Semester 2 > Labelling of Relevant Medicinal Products > Flashcards

Labelling of Relevant Medicinal Products Flashcards

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1
Q

What is a relevant medicinal product?

A

a product that is industrially produced and holds an MA

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2
Q

What is the legal basis of labelling?

A

specified under the HMR 2012 Part 13

additional requirements of CDs are stated under the Misuse of Drugs Regs 2001

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3
Q

What are the general labelling requirements?

A
  • easily legible
  • comprehendible
  • indelible
  • written in ENGLISH ONLY or English + Extra Language - have to be able to understand the product
  • name of the medicinal product HAS to be in braille format on the outer packaging for the blind/partially sighted
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4
Q

What are the requirements on the outer and immediate packaging of a relevant medicinal product? (18)

A
  1. Name
  2. Strength & Form
  3. Intended for Babies/Children/Adults
  4. Up to 3 active substances (in the common name)
  5. Statement of Active Substances
  6. Pharmaceutical Form and Contents
  7. List of Excipients
  8. Method of Administration
  9. Space for the dispensing label for prescribed dose
  10. ‘Must be stored out of reach and sight of children.’
  11. Special Warnings
  12. Expiry Date
  13. Special Storage Precautions
  14. Special Precautions for Disposal
  15. Name and Address of the MA
  16. Number of the MA (PL)
  17. Manufacturers Batch No.
  18. Instructions for use if not a POM

& legal classification P/POM/CD
& a package leaflet - not a requirment

NO ELEMENT OF A PROMOTIONAL NATURE

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5
Q

What are the NAME requirements on the outer and immediate packaging of a relevant medicinal product?

A
  • international non-proprietary name (generic)
  • common
  • brand
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6
Q

What are the STATEMENT OF ACTIVE SUBSTANCES requirements on the outer and immediate packaging of a relevant medicinal product?

A

the active substances in the product has to be expressed qualitatively and quantitively per dosage unit OR according to form of administration for given volume/weight using their COMMON NAMES

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7
Q

What are the FORM AND CONTENTS requirements on the outer and immediate packaging of a relevant medicinal product?

A
  • weight
  • volume
  • number of doses in the product
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8
Q

What are the LIST OF EXCIPIENTS requirements on the outer and immediate packaging of a relevant medicinal product?

A

include if they contribute to the pharmaceutical form

  • if the product is injectable/topical/eye preparation
  • if the excipient is known to have recognised action or effect (e.g. food allergies)
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9
Q

What are the precautions relating to disposal requirements on the outer and immediate packaging of a relevant medicinal product?

A
  • unused product
  • waste derived from a product
  • reference to any appropriate collection system in place
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10
Q

Exceptions to the immediate packaging requirements of a medicinal product?

A
  • if the blister pack is contained in an OUTER packaging that contains all the required information
  • if the packaging itself is too small to display all of the information required
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11
Q

Only requirements needed on a blister pack if all of the outer packaging contains all of the requirements?

A
  • Name of Product
  • Strength & Form
  • Intended for Babies/Adults/Children
  • Common name of each active substance (up to 3)
  • Name of the MA holder
  • Expiry Date
  • Batch Number

Small containers also need to have the method of administration

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12
Q

Is the address of the patient a legal requirement on a dispensed medicinal product?

A

NO

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13
Q

What are the additional labelling requirements for products containing PARACETAMOL?

A
  • ‘Contains Paracetamol’; except for where the name of the product includes the word paracetamol, and the name of the product is on the outer and immediate packagins
  • ‘Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor’; HAS to appear next to the directions for use/recommended dosage
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14
Q

Additional labelling requirements for a paracetamol PREPARATION that DOESN’T have a leaflet?

A

‘Talk to your doctor at once if you (your child) take too much of this medicine, even if you (your child) feel well. This is because too much paracetamol can cause delayed, serious liver damage.’

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15
Q

Additional labelling requirements for a paracetamol PREPARATION that HAS a leaflet that already has the liver damage statement?

A

‘Talk to your doctor at once if you (your child) take too much of this medicine, even if you (they) feel well.’

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Law Semester 2 (16 decks)

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