Revised: 6 May 2013

Medicines

Proprietary Ingredients

Medsafe has generated a register of Proprietary Ingredients to ensure accurate and up to date information is held on Proprietary Ingredients used in pharmaceutical products marketed in New Zealand.

All sponsors that currently market an approved medicine in New Zealand were contacted by Medsafe in September 2007 and requested to supply information for each Proprietary Ingredient used in their products.

Registration of a Proprietary Ingredient with the database

The Medicines Act 1981 requires sponsors to disclose all ingredients in a product including the formulation and manufacturing controls on Proprietary Ingredients. This information is used to register Proprietary Ingredients with our database. The database is independent of product files (TT50- files) thereby allowing several sponsors to quote a common Proprietary Ingredient in their formulations.

Proprietary Ingredients may include colours, coatings, flavours, printing inks and emulsifiers.

To assist us in the generation of an accurate database, the following information is required to register a Proprietary Ingredient:

• The full name of the Proprietary Ingredient
• Any unique identification number associated with the Proprietary Ingredient
• The manufacturer name
• The qualitative formulation
• The quantitative formulation
• A copy of the specifications from either the sponsor or the manufacturer

The following information will not be acceptable in fulfilling the above requirements:

• Material safety data sheets - these do not list all the ingredients
• The Proprietary Ingredient's ARTG number from Australia's TGA - Medsafe cannot obtain the required information from the TGA

The sponsor can request the supplier of the Proprietary Ingredient to provide the information directly to Medsafe for confidentiality. The information can be submitted electronically or by post.

Any Proprietary Ingredient that is notified to Medsafe is registered with the database and allocated a unique file number (TT70- file number). This file number can be quoted in all subsequent applications instead of submitting the required information. File numbers are sent to companies upon registration.

Proprietary Ingredient Request Form

This form has been developed to act as an 'audit trail' between companies that market registered medicines, the Proprietary Ingredient supplier and Medsafe to assist all parties monitor the information flow. Medsafe regards the use of the form as voluntary.

This form has been prepared in response to difficulties in collecting the confidential information from Proprietary Ingredient suppliers. The sections to be completed in the form have been developed based on the information required to register a Proprietary Ingredient in the database.

Proprietary Ingredient Form (30KB this is a pdf document and Acrobat Reader is required for viewing)

Registration Search

Proprietary Ingredients can be checked for registration by searching the 'ingredient field' in the Medsafe Product/Application database.

The Proprietary Ingredient name can be entered to search for registration.

• Colours, coating agents and inks are registered as brand name, colour, ID number
  eg. Opadry white 123456
• If the colour or ink does not have a brand name, special categories of colours and inks are used to register them
  eg. Edible ink 123456
• Flavours are registered as type, flavour, ID number
  eg. Orange flavour 123456

Alternatively, the finished product name can be searched in the Medsafe Product/Application database under the "trade name field" to check for Proprietary Ingredient registration. The information for registration will appear in the product details under the excipient section.

Registered Proprietary Ingredients have a TT70 file number alongside the Proprietary Ingredient name. If a Proprietary Ingredient is registered but is not linked to your product, please contact Medsafe to confirm the use of the Proprietary Ingredient in your product.