Labelling

Question 1

What language must labels for medicinal products be written in?

Answer 1

English + one or more other languages

Question 2

What is required on packaging for blind and partially sighted patients?

Answer 2

Name of medicinal product in Braille on outer packaging

Question 3

List all the schedule 24 packaging information requirements

Answer 3

Name of medicinal product, strength and form, batch number, whether product is for babies, children or adults, common name of each active substance where product contains up to 3 active substances, list of excipients, method and route of admin, expiry date, warning that product must be stored out of reach and sight of children, special warnings, storage requirements, name and address of MA holder, MA number, precautions related to disposal/waste, P POM or CD in rectangle/triangle for CD

Question 4

List the label requirements for a blister pack.

Answer 4

Batch number, name of product, strength and form, whether product is for babies, children or adults, common name of each active substance (up to 3), name of MA holder, expiry date.

Question 5

True or false, small packs need the same information as blister packs + method and route of administration?

Answer 5

True

Question 6

When does a product containing paracetamol not need to state “contains paracetamol”?

Answer 6

When the name of the product includes the word paracetamol and it appears on the outer and immediate packaging