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What's new in this release  

The Source of Truth for Market Authorization Holders (MAH) and Immunizing Agents and their abbreviations have been updated. Please refer to the Immunization page for the details. 

 The Out of country products and Special access programs guidelines has been updated. Please refer to the Immunization page for the details. 

Special access and out of country products

Stakeholders of the Public Health Community have requested to create terminology concepts for the WHO-authorized vaccines administered outside of Canada. This is to support use cases related to international travel back to/into Canada (e.g. snowbirds, newcomers, etc.). This will help with immunization surveillance and will allow to have a more comprehensive understanding of vaccination coverage rates in Canada.

Special Access Products (SAPs) and international vaccines cannot be found on DPD. There are no MAH for these products as they are not licensed in Canada. The new pattern will be as follows: 

Pattern:   

FSN: Trade Name (qualifier) Strength Dose Form  (real clinical drug)  

English PT: PHAC Product Abbreviation Trade Name (qualifier) (strength)  

Administrable Passive Immunizing Agents 

This content is designed for use when populating a record at the point of administration and includes concepts represented by the trade name (brand name) of the passive immunizing agent (immune globulin or antitoxin) that was administered to the client. It consists of concepts from the Proprietary Medicinal Product class and class and from the SNOMED CT Pharmaceutical CT Pharmaceutical / biologic product hierarchyproduct hierarchy, that  that are described using their trade name (brand name). 

Scope Definition: 

The scope of this subset is passive immunizing agents that are currently licensed for use in Canada and those obtained through special access programs. The subset includes concepts represented by the trade name (brand name) of the passive immunizing agent (immune globulin or antitoxin) that was administered to the client. The scope of this subset is all passive immunizing agents that have been licensed for use in Canada, those obtained through special access programs for use in Canada, and those that were never licensed in Canada (i.e., administered in other countries). Passive immunizing agents are used to facilitate protection against vaccine preventable infections, when vaccines are not available or are contraindicated or when vaccines have not been used before exposure to the infective agent. This content is intended to be used when populating a record at the point of administration.

General rules applied to this section 

• The passive immunizing agents trade names will be represented as found in the
product monograph
• Health Canada Drug Product Database (DPD) :it may be a mix of capital and lower-case letters;
• In most cases, the product trade name will be represented as found in the product monograph or as listed on PHAC, CIG, Part 5, Passive Immunization web page : it may be a mix of capital and lower case letters. 
• There is a requirement to clarify this rule going forward in relationship to the ‘sources of truth’ prioritization, where the capitalization has not been compliant. 

• NOTE: PHAC does not assign manufacturers or marketing authorization holders (MAH) abbreviations for the passive agents, as these products are managed on a province-by-province basis (versus nationally). Some of the MAH also produce vaccines, so the PHAC abbreviation is used in those cases.  For those manufacturers or MAH without a PHAC abbreviation: an abbreviation has been assigned by Infoway, using the PHAC abbreviation guidelines. A similar situation may occur with the vaccine product manufacturer or MAH abbreviations, as PHAC uses distributer, not manufacturer, so there may be gaps. Refer to the Immunization Page - Main Reference Documentation section.

• The product monograph is a reference for validation of detailed information.  

Fully Specified Name Fully Specified Name

The format for the Fully Specified Name (FSN) is as follows: 

• Trade name (qualifier) Strength

•  Dose Form

•  Marketing Authorization Holder (MAH)

•  (

• real clinical drug)  

• • E.g.: HepaGam B

• •  312 international units per milliliter liquid for injection

• •  Cangene Corporation (

• • real clinical drug) 

 FSN  FSN Components 

• A qualifier may be added to FSN 

• Refer to
the 
• the VaccineAdministeredTradeNameCode subset for details about other FSN components.  

Preferred Synonym (English) 

For further details on PS, please refer to the Picklists guidelines.  

The format for the Preferred Synonym (PS) is as follows: 

• [PHAC/CHI Abbreviation Product

• ] Trade name (qualifier)(strength)

•  (Marketing Authorization Holder (MAH) Abbreviation if required)  

• • e.g.: [HBIg] HepaGam B (STR) 

PS Components 

• When adding a qualifier on the PS, it is not capitalized, unless otherwise represented in the product monograph. 

• Refer
to the 
• to the VaccineAdministeredTradeNameCode
subset for
•  subset for details about other PS components 

Preferred Synonym (French) 

• La plupart des synonymes privilégiés en français sont les même qu’en anglais, à l’exceptions de certaines abréviations qui peuvent différer. 

• Quand il n’a pas été possible de trouver une abréviation en français l’abréviation anglaise a été conservée.  

• • Par exemple :[CMVIg]Cytogam
CSL
• •  ou[BIG-IV]BabyBIG
CDPH
• •