Draft guidance on the plain language labelling regulations for prescription drugs: General plain language requirement

Section A.01.017 of the Food and Drug Regulations (regulations) states:

Every label of a drug for human use in dosage form shall meet the following conditions:

1. the information that is required by these regulations to appear on the label shall be
   1. prominently displayed on it
   2. readily discernible to the purchaser or consumer under the customary conditions of purchase and use, and
   3. expressed in plain language and
2. the format of the label, including the manner in which its text and any graphics are displayed on it, shall not impede comprehension of the information referred to in paragraph a)

Purpose of plain language requirement

This requirement is to ensure that:

• information on labels of drugs for human use can be easily understood by users and
• the format or presentation of labels helps understanding

It underpins the more specific requirements included in the regulations.