containers + packaging

Question 1

parallel import

Answer 1

non-counterfeit product imported from another country without permission of intellectual property owner

Question 2

What must appear on the packaging of medicinal products?

Answer 2

1) name/form/strength
2) active ingredients
3) number of dosage units/volume
4) list of excipients
5) method of administration
6) warning that medicine should be kept out of reach + sight of children
7) any other warnings necessary for product
8) expiry date (month/year)
9) any special storage requirements
10) any special precautions relating to disposal
11) name + address of marketing authorisation holder
12) number of marketing authorisation
13) manufacturer’s batch number
14) instructions for use for non-prescription medicine

Question 3

What must appear on the packaging of blister packs?

Answer 3

1) name/strength/form
2) expiry date (month/year)
3) name of marketing authorisation holder
4) batch number

Question 4

What are the two types of warning labels?

Answer 4

1) pharmaceutical warnings

2) BNF warnings

Question 5

What do pharmaceutical warnings relate to?

Answer 5

type of formulation

Question 6

What information is found on patient information leaflets?

Answer 6

1) identification of medicinal product
2) therapeutic indications
3) list of information that is necessary before taking medication
4) necessary + usual instructions for proper use
5) description of undesirable effects that can occur with normal use + action to be taken in such cases
6) reference to expiry date on label
7) date on which leaflet was last revised

Question 7

If a relevant medicinal product is packaged in a small container that cannot show all the normally required information, what information MUST appear?

Answer 7

1) batch number

2) name of the product