All those who have been anxiously awaiting the full implementation of the Electronic Lodgement Facility (ELF) listing system will be pleased to know that the Therapeutic Goods Amendment Bill 1995 is currently before Parliament.

The manual processing of applications during the past few months has revealed four areas where some applicants appear uncertain of the correct way to complete the form. The following explanations may assist:

• In items 19 and 20 ingredients' quantities should be expressed in terms of w/w, v/v, w/v, etc where the preparation is a liquid or dry preparation - such as an oral liquid, powder or dried herb. But, as has always been the case, where there is a discrete dosage form such as a tablet or capsule, the quantity stated for the ingredient should be the quantity (by weight or volume) in a single dose unit, ie. the quantity contained in one tablet or capsule. Note that a tea bag is regarded as a container ("bag"), not a dosage form, so the ingredients should be stated as w/w, for example as xmg/g or 1g/g where the contents consist of a single substance.
• Copies or drafts of all the product material itemised in item 29 should be provided as attachments to the application (see "J" in the attachments declaration). Each item should be clearly identified as, for example, the container or primary pack label and marked J1, J2, etc to correspond with the number of pages indicated in the declaration.
• If foreign language text is included on labelling, an English translation needs to be provided, or a signed statement that the words in the foreign language are an exact translation of the information that is in English. (Note that TGO No.48 requires all the essential label information to appear in English).
• Special attention needs to be given to the coding in item 17 to ensure that the correct code for the product type is inserted. This code information is matched by ELF with the information given in item 25 to validate the GMP status of the manufacturer for both the step in manufacture and the product type. Incorrect coding can therefore lead to a false validation result. Similarly, it is essential that the step in manufacture is correctly coded. Before lodging the application, applicants should consult the published manufacturer's licensing list to ensure that the nominated manufacturer is licensed to carry out the particular step of manufacture for the product type concerned.