In response to sponsors seeking authorisation to add extra information to prescription drug labels, Health Canada has released a draft guidance document detailing the agencies expectations on the use of electronic platforms to disseminate information on a prescription drug product.
Electronic platforms, which refer to any type of electronic media (such as websites) used to distribute information, will be linked to the specific product’s label. A barcode or web address provided on the drug label can be used to link the product to the electronic platform. A drug label refers to any legend, word or mark attached to, included in, belonging to or accompanying a drug and traditionally this applies to a drug’s:
- Package inserts
- Inner and outer labels
- Product monograph (PM)
- Any other physical materials generated by a sponsor that are included in the drug package or supplied at the time of dispensing.
It is important to note that this guidance document refers to the use of electronic media to provide supplementary information on a product. This is a voluntary activity, and the information distributed on an electronic platform cannot be used to replace information that is required by law to appear on a drug’s physical label. This document does not refer to electronic platforms that contain electronic versions of approved PMs or package inserts.
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