12(21)-1 Labelling of RMPs BB

What are the key components that must be included in the packaging information for medicinal products according to Schedule 24?

Name of the medicinal product, common names of active substances, and quantitative information about active substances per dosage unit.

The Human Medicines Regulations 2012 cover labelling requirements under which parts?

Part 13 covers packaging and leaflets; Schedule 24 is for packaging information requirements.

What does INN stand for in relation to medicinal products?

International Non-Proprietary Name, which is equivalent to the generic name.

According to the labelling requirements, how must the name of the medicinal product be presented?

It must be easily legible, comprehensible, indelible, and expressed in Braille on the outer packaging.

What additional information must appear on the outer packaging and package leaflet?

Symbols or diagrams to clarify information, and other patient-compatible information, but no promotional elements.

If medicinal products have a blister pack, what is an exception to the labelling requirements?

It can be placed in outer packaging that complies with labelling requirements.

What must appear on products containing paracetamol, unless 'paracetamol' is already in the product name?

A statement saying 'Contains paracetamol' must appear on outer and immediate packaging.

What does the 'P' in a rectangle signify on a pharmaceutical product?

It indicates that the product is classified as a Pharmacy (P) medicine.

What warning must appear adjacent to directions for use on paracetamol products?

'Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor'.

What percentage of parents in a YouGov survey were unaware that Calpol contained paracetamol?

17% (1 in 6) parents of children aged 12 or under did not know.