Manufactured Product (MP)

This section describes the rules that govern the description of a unique Manufactured Product and the naming pattern used for Manufactured Products.

Describing MPs

Waters of Hydration

See also Appendix C, Hydration and Solvation

Water of hydration information is present for the precise ingredient substance in a small number of Manufactured Products. The Canadian Clinical Drug Data Set describes the rules for how waters of hydration will be represented (see Appendix C). In MP concepts, in order to correctly identify (for mapping purposes) those Manufactured Products where waters of hydration are included in the precise active ingredient substance, this information will be included in the MP formal name pattern.

The following table provides examples of how waters of hydration will be applied to the MP:

MP Naming Pattern

A correct and unambiguous formal name for the MP will enable vendor mapping to their local content. 

MP names use the DPD Product Name and the DPD Company Name, with the associated NTP name placed in brackets between these two, with the addition of any solvate/hydrate description included for the substance(s) in the NTP part of the name.  In the small number of cases where this produces duplicate MP names, the DPD Descriptor (if one exists) is added after the DPD Product Name.  

The DPD Company name, as used in the Health Canada DPD, indicates the organization (company) that holds the authorization to place the product on the market in Canada, i.e., the market authorization holder.  This may not be the company that has manufactured the product, but it is the company that holds the legal responsibility for the use of the product in Canada and should be the same as the company named on the product label/packaging.

The DPD Product Name, DPD Descriptor and DPD Company Name will use the letter case as it is in the DPD, which is usually upper case, whereas the NTP name in brackets will be all lower case.

This can be summarized as:

<<DPD PRODUCT NAME>> <<(ntp name)>> <<DPD COMPANY NAME>>

when de-duplicating MPs names, this pattern will be:

<<DPD PRODUCT NAME>> <<DPD DESCRIPTOR>> <<(ntp name)>> << COMPANY NAME>>

and occasionally, when solvation is present in a precise ingredient substance:

<<DPD PRODUCT NAME>> <<(ntp name including waters of hydration)>> << COMPANY NAME>>

MP Formal Name and French Description for Single Ingredient

For single ingredient products, the pattern will be as follows:

<<Product name>> <<(ntp name)>> << Company Name>>

Examples: 

MP Formal Name and French Description for Multiple Ingredient

For multiple ingredient products, the pattern will be as follows:

<<Product name>> << (ntp name)>> << Company Name>>

Examples:

Where multiple MPs have different MP codes (and different DINs) but a non-unique MP Formal Name:

Table of Examples of MP concepts with a modified MP formal name pattern where the DPD descriptor is added:

Note that there are some products that even with this additional rule, still generate non-unique MP Formal Names; however, this is acceptable if only one of the products has a status of Active.  In the event the DPD descriptor does not provide useful differentiating information, the DPD PRODUCT NAME in the CCDD will be modified to create a meaningful distinction between the products.

Manufactured Product Name Changes

Current Health Canada policy allows pharmaceutical companies to transfer ownership of a product while retaining the same DIN.  This means that the Company Name component of a CCDD Manufactured Product may change although the mp_code remains the same.  Similarly, product names may undergo minor changes, usually to remove strength or dose form information, but also to remove a prefix from a generic manufactured product name. 

Examples of MP name changes:

For a medicinal product terminology such as CCDD, this level of change in the formal name of a concept is not ideal.  The situation is under active review.