Guidelines and Codes
Explanatory Note on Section 6.10 Proprietary Names
[NZRGM, Volume 1, 5th edition]
Added to web site: September 2004
PRODUCT NAMES AND UMBRELLA BRANDING
Background:
The issue of product names and umbrella branding has been the source of much debate and comment within and between Industry and Regulators. Various proposed models and guidelines and have been prepared and presented by interested parties. The current NZ legislation requires that each new product have a "unique and distinct" product name. The current Australian legislation requires that each new product is uniquely identified as different from all other products.
Current practice:
Medsafe use the following algorithm as the basis on which we interpret the current guideline for product names as published in NZRGM, Volume 1, 5th Edition.
Further Explanation:
This algorithm is more simplistic than other models proposed to Medsafe in the past as experience has shown that in trying to be specific and inclusive, there are always a significant number of exceptions and/or proposals that do not fit.
A product name is seen as the thing that uniquely identifies a product from all other products on the market. Umbrella branding relates to the use of a brand identifier to identify certain products as being part of a specific product range. It can be considered as part of the identification of a product, but is only a part of the total consideration of product name.
Colour, text, pictures and layout have all been proposed as a means to separately identify different products within a range. While these factors can be seen as additional factors to safety and product identification, they all have the potential for change (possibly self-assessable change), without assessment but with considerable impact on safety of use. Consequently these may be considered as additional, but are not included as alternative, identifiers of products within a range.
Current Medsafe policy is for clear identification of separate products through the product name, rather than the requirement of additional warning statements to labelling to provide a safety net for consumers for products where the product names are considered very similar.
PRODUCT NAMES
Medsafe proposes a product name may consist of three distinct components, only one of which (Component B) is compulsory, and must comply with the legislative requirement to be the most dominant text on the PDP.
Component A
Brand or Range Identifier
Component B
Product Name
Component C
Additional Product Descriptor
Component A;
This component may often be present as a logo, or company /brand range trademark. If may represent a company, or identify the product as being part of a product range within a company.
Component B;
This is the only compulsory component in a product name. It must be present as the most dominant text on the product labelling. It must not be misleading in any way with regard to the nature, composition, purpose, uses or effects of the product. It must either
- be unique to the product and not unacceptably similar to, or likely to be confused in any way with any other medicine or related product currently registered in NZ; or
- accurately describe and distinguish the product from all other products currently registered in NZ. (NB If the proposed name is that of a pharmacopoeial monograph, Components A and C may be used to distinguish the proposed product from others on the market).
A product name should always be associated with only one, or the same combination of, active ingredients.
Component C
This component may be used to further distinguish between similar products in a range, e.g by flavour, strength, dose form, sugar free etc).
Additional considerations
The history of marketing of product in NZ may also affect Medsafe's concerns regarding safety and identity.