Draft guidance on the plain language labelling regulations for prescription drugs: Appendix A, abbreviated package inserts

An abbreviated package insert may be created when a sponsor is not able to create a package insert that fits the entire contents of Part I of the product monograph or prescribing information at the required minimum font size to be considered legible.

Note: In all cases, the patient medication information or Part III: consumer information cannot be abbreviated.

An abbreviated package insert should consist of either:

• Sections of Part I of the product monograph or prescribing information or
• Sections of Part I of the product monograph or prescribing information and all of the patient medication information (Part III: consumer information) 

Headings

An abbreviated package insert should:

• clearly define their limitations and
• refer health care professionals to the product monograph or prescribing information for complete product information

Include 1 of the following headings in bold font:

• Abbreviated Package Insert for Reconstitution, Administration and Dosage
  • See product monograph for complete product information
• Abbreviated Package Insert for Reconstitution, Administration and Dosage
  • See prescribing information for complete product information
• Abbreviated Package Insert
  • See product monograph for complete product information
• Abbreviated Package Insert
  • See prescribing information for complete product information

A link (for example, a QR code) that is included to access the product monograph or prescribing information electronically should conform with the Notice – Interim implementation of electronic labelling for human prescription drugs.

Contents

Sponsors may propose which sections of the product monograph or prescribing information they would like to be included in the abbreviated package insert. However, at a minimum the following recommended sections should be included:

Section heading	Recommendation
Indications	Optional
Contraindications	Recommended
Serious warnings and precautions box	Recommended
Dosage and administration	Recommended
Overdose	Recommended
Dosage forms, strengths, composition and packaging	Recommended
Warnings and precautions	Optional
Adverse reactions	Optional
Drug interactions	Optional
Clinical pharmacology	Optional
Storage, stability and disposal	Recommended
Special handling	Recommended

The sections should match the content of the product monograph or prescribing information.

These are general recommendations, however, consideration should be given to the product type of each drug product. Additional sections of the product monograph and prescribing information may be included during review to ensure the safe use of the product.

For example:

• Warnings and precautions may be recommended to be included for vaccines.
• Dosage forms, strengths, composition and packaging section may not be required for radiopharmaceuticals.
• Indications authorized with NOC/c may be recommended to be included to disclose the nature of the approval.

Sponsors should consider the following criteria when determining other sections to include. A rationale should be provided in the note to reviewer to support the format chosen and the specific sections included or excluded.

The sections in an abbreviated package insert should provide:

• suitable directions for use to the end user (health care professionals, caregivers and products self-administered by an end user) to adequately prepare, reconstitute, dose and administer the product
• relevant safety information based on the conditions of use of the product and the product’s risk factors, including unconventional or unusual features of the drug (for example, unusual missed dose directions)

Should the sponsor require further direction on creating an abbreviated package insert, sponsors are encouraged to contact Health Canada:

• For pharmaceutical drugs: pdd.bgivd.ld-dmp.bgmiv.de@hc-sc.gc.ca
• For biologics and radiopharmaceutical drugs: brdd.ora@hc-sc.gc.ca