[^MedicinalProductAuthorization related wording changes.v5.docx]

 

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RegulatedAuthorization resource wording and definition changes

Background:

 

As the scope of the RegulatedAuthorization (previously called MedicinalProductAuthorization) resource has been broadened to cover all regulatory authorizations some of the wording and definitions need to be updated to reflect the broader scope.

Issues:

1. The description section for MedicinalProductAuthorization currently reads:

"The regulatory authorization of a medicinal product, device or process."

Suggest it be changed to:

“The regulatory authorization of a product, device, process or facility. Products include medical as well as biologically derived, nutritional, etc."

1. The Scope and Usage section for MedicinalProductAuthorization currently reads:

"RegulatedAuthorization is a resource covering the authorization of a type of medicinal product, item, treatment or service, from a regulatory point of view. "

suggest that be changed to:

“RegulatedAuthorization is a resource covering the authorization of a type of product, item, treatment, facility or service, from a regulatory point of view. "

1. In the Scope and Usage section for MedicinalProductAuthorization this may cover subsection add the following examples:

 

“Approval for a facility to be used in the storage, manufacturing, distribution, or any other regulated aspect for regulated items”

 

“Approval for a process such as the storage or distribution of controlled substances”

 

1. The current definition for RegulatedAuthorization reads:

"The regulatory authorization of a medicinal product, device or process." 

suggest modifying to:

"The authorization or licencing of a regulated product, facility or activity, including items such as medicinal products, medical devices as well as related processes, facilities and activities."

1. The current definition for RegulatedAuthorization.case.application reads:

"Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure."

suggest changing to:

"Application submitted to obtain an authorization or a licence. The application typically triggers or is connected to a case or procedure that deals with the request

1. The current definition for RegulatedAuthorization.case reads:

"The case or regulatory procedure for granting or amending a marketing authorization."

suggest changing to:

"The case or regulatory procedure for granting or amending the authorization."

1. The current definition for RegulatedAuthorization.case.identifier reads:

" Identifier by which this case can be referenced."

suggest changing to:

"Identifier by which this case can be referenced. Identifier by which this case can be referenced such as the Health Canada Dossier ID”

1. The current definition for RegulatedAuthorization.case. type reads:

"The defining type of case."

suggest changing to:

"The defining type of case, i.e. the applicable regulatory approval framework such as the US Food and Drug Administration (FDA) New Drug Application (NDA) "

 

1. The current definition for RegulatedAuthorization.regulator reads:

"Medicines Regulatory Agency."

suggest changing it to:

"The Regulatory Agency granting the approval. Examples include EMA, FDA, HC, etc. "

1. The current definition for RegulatedAuthorization.validityPeriod reads:

"The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format."

Suggest changing to:

"The time period in which the authorization or licence is in the current state."