Guidance Document - Creation of the Canadian Module 1 Backbone

Creation of the Canadian Module 1 BackboneHealth CanadaGuidance DocumentFigure 2: Example showing Element4.1.1 The ElementThis mandatory element contains the sponsor's name, i.e. the company which issubmitting this regulatory transaction. This element cannot be repeated. There are noschema-level constraints (i.e. content rules) on this element. Great care should be takento ensure accuracy and consistency with this content. For example, the values “MyCompany” or “My Company, Inc.” or “My Company, Inc” are all different which maycause difficulties or delays in the processing of the regulatory transaction.4.1.2 The ElementThis mandatory element contains the drug name, i.e. the product which is beingaddressed in this application. This element cannot be repeated. There are no schemalevelconstraints (i.e. content rules) on this element. Great care should be taken to ensureaccuracy and consistency with this content. For example, the values “My Product” or“My product” or “My Product” (note the double space!) are all different which may causedifficulties or delays in the processing of the regulatory transaction.4.1.3 The ElementThis mandatory element contains the unique identifier assigned to this dossier by HealthCanada. This element cannot be repeated. It must be in the format “e999999”, i.e. alower case letter followed by six digits. It is expected that the sponsor will acquire avalid dossier identifier from Health Canada before submitting the initial regulatorytransaction.4Revised Date: 2012/08/03; Effective Date: 2012/09/30