Electronic media in prescription drug labelling guidance: Legal requirements

On this page

• Legal framework
• Information you can distribute through electronic platforms
• Federal labelling laws apply to electronic platforms linked to a prescription drug label
• Federal advertising laws apply to electronic platforms linked to a prescription drug label

Legal framework

The legal framework that governs the use of electronic media in prescription drug labelling includes:

• the Food and Drugs Act (FDA)
• the Food and Drug Regulations (FDR)
• certain provisions of the Controlled Drugs and Substances Act (CDSA) and its Regulations for prescription drugs containing controlled substances

Under this legal framework, you are permitted to distribute information through an electronic platform that is linked to a prescription drug label, for example the:

• package insert
• inner and outer label

However, you must comply with the rules set out by the Acts and Regulations that form this framework, particularly federal laws related to prescription drug labelling and advertising.

Any personal information collected through interaction with an electronic platform is subject to the Personal Information Protection and Electronic Documents Act (PIPEDA), the federal privacy law for private-sector organizations.

Information you can distribute through electronic platforms

Health Canada recognizes the PM, including Part III (also known as the patient medication information or consumer information section), as the complete and factual account of a product's:

• claims
• properties
• conditions of use
• safety and efficacy

However, you may wish to distribute more information in order to help prescription drug users better understand your product and the condition for which it was prescribed. This information can include:

• alternative presentations of parts of the PM, such as a video that demonstrates how to accurately administer a medication
• more general, non-drug specific information, such as disease management strategies or lifestyle recommendations

Broadly speaking, the FDA does not prohibit you from distributing information beyond that which is legally required, provided that the information complies with Section 9 of the FDA. To ensure compliance with this provision, you should be mindful of a product's Terms of Market Authorization (TMA). The TMA is understood to mean the collection of labelling information associated with a product that has been approved by Health Canada as part of its regulatory drug review process.

Any information which meets the definition of a 'label' or 'advertisement' in the FDA would be subject to specific legal requirements under the:

• FDA and its regulations
• CDSA and its regulations for drugs containing controlled substances

Federal labelling laws apply to electronic platforms linked to a prescription drug label

The FDA provides the following definition for a label: "includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package." This definition is often used to refer to physical labels such as inner and outer labels or package inserts. However, the words "belonging to" expand the definition of a label to include a legend, word or mark that extends beyond that which is physically connected to the drug. In this context, the words "belonging to" can apply to electronic information under certain conditions.

Health Canada considers information on an electronic platform to meet the definition of a label when:

• reference to the electronic platform is made on a drug's label, for example through a link, and
• the electronic platform which has been referenced contains information that speaks directly to topics covered by the label of the drug in question, that is drug information

Electronic materials that meet both of these conditions, henceforth referred to as electronic labels, must comply with federal drug labelling laws. Information is not considered to be part of a drug's label if it is:

• on an electronic platform that is not linked to the label
• unrelated to topics covered by the label of the drug in question, for example, general health information.

In this way, an electronic platform can contain both labelling and non-labelling information.

Although an electronic platform can sometimes be an extension of a drug's label, it does not mean that all information required to appear on a label can be transferred to an electronic platform. As the terms "inner label" and "outer label" are narrowly defined in the FDR to only mean the label which is "on or affixed to the immediate container or the packaging of a food or drug," the relocation of information required to appear on inner and outer labels to an electronic platform is generally not permitted.

The majority of labelling requirements under the FDA and FDR pertain to information that must appear on a drug's physical package, namely its inner and outer labels. However, certain provisions apply to all forms of labels, including electronic labels.
You must provide mock-ups of every label with each of the following submission types:

• Drug Identification Number application (DINA) or Drug Identification Number application for a biological product (DINB) (Section C.01.014.1(2) of the FDR)
• (abbreviated) new drug submission ((A)NDS) or supplement to an (abbreviated) new drug submission (S(A)NDS) for assessment (Sections C.08.002(2) and C.08.003(3.1) of the FDR)

Federal advertising laws apply to electronic platforms linked to a prescription drug label

Federal advertising laws apply to advertising in any medium, including electronic media. The FDA defines an advertisement as "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device." Representations that are deemed advertising are subject to the following key provisions:

• the promotion of a drug is limited to authorized drugs (Section C.08.002(1) of the FDR)
• a drug may not be advertised in a manner that is false, misleading or deceptive (among other conditions) (Section 9 of the FDA)
• the promotion of a prescription drug to the general public is limited to name, price and quantity (Section C.01.044 of the FDR)
• a drug may not be advertised to the general public for the treatment, prevention or cure for any Schedule A.1 disease, disorder of abnormal physical state (Section 3 of the FDA)
• controlled drugs, narcotics and targeted substances may not be advertised to the general public (Section G.01.007 of the FDR, Section 70 of the Narcotic Control Regulations and Section 78 of the Benzodiazepines and Other Targeted Substances Regulations)

These provisions strictly limit the degree of prescription drug advertising that you can conduct. However, the information would be considered non-promotional in nature and exempt from the key provisions if the information was presumed:

• to inform health care providers administering the drug
• intended solely to educate patients for whom the drug has been prescribed

You must ensure that only these patients and their health care providers have access to this information. Distributing this type of information outside of this context could be considered promotional, and therefore trigger the key provisions.