Therapeutic Goods Regulations (Amendment) 1994 No. 364
EXPLANATORY STATEMENT
Statutory Rules 1994 No. 364
Issued by authority of the Minister for Family Services
Therapeutic Goods Act 1989
Therapeutic Goods Regulations (Amendment)
The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
Sections 18 and 63 of the Act enable the Governor-General to make regulations prescribing, among other things, matters necessary or convenient to be prescribed for carrying out or giving effect to the Act and setting the fees payable in respect of such matters. This includes:
Subsection 18(1)
• exempting therapeutic goods from inclusion in the Australian Register of Therapeutic Goods, subject to specified conditions;
Paragraph 63(2)(c)
• prescribing requirements for the advertising of therapeutic goods;
Paragraph 63(2)(e)
• prescribing requirements for informational material that is included with therapeutic goods;
Paragraph 63(2)(h)
• providing for the setting of fees in respect of matters under the Act or the regulations.
Accordingly, the regulations:
(a) provide exemption from inclusion in the Australian Register of Therapeutic Goods of therapeutic goods which are manufactured by a licensed manufacturer to the particular formulation specified by a public or private hospital or a public institution, subject to the conditions that no equivalent product is already available in the market place through inclusion in the Register and that, on a quarterly basis, the licensed manufacturer notifies details of the goods so manufactured to the Secretary.
This provision enables a hospital/institution to obtain and use special therapeutic products which are not otherwise available and are not able to be prepared by the hospital or institution's pharmacy, while ensuring that the Secretary has information which enables the monitoring of the manufacture and supply of such goods;
(b) include additional professional bodies in Schedule 1 to the Regulations so that advertising restrictions under Part 2 of the Regulations designed principally for control of advertising to consumers, will not affect members of the specified bodies;
(c) change the requirement for a person to supply patient information with those therapeutic goods specified in Schedule 10, which are approved for registration on or after 1 January 1993, so that this requirement applies only to the sponsor of the goods. This amendment preserves an existing obligation for the sponsor, removes the obligation for other persons and does not include any new obligation which has a retrospective effect;
(d) amend the amount of the reduction in evaluation fees for simultaneous evaluations which was included in the regulations by Statutory Rule No. 222 effective 1 July 1994. The amendment corrects the regulation to reflect the original intention of the Government that only one evaluation fee will apply where up to three applications are made simultaneously, an additional, but reduced, fee will apply where more than three simultaneous applications are made.
In addition, the Regulations revise wording of some provisions to clarify meaning and correct grammatical or spelling errors.
Further details of the amendments are set out in the Attachment.
The Regulations commenced on Gazettal.
ATTACHMENT A
DETAILS OF REGULATIONS
Subregulation 2.1 inserts the definition of a 'quarter' for the purposes of new item 5 of Schedule 5A.
Subregulation 3.1 replaces the obligation, in subregulation 9A(1), on a person, to supply patient information with therapeutic goods approved for registration, with an obligation on the sponsor of the goods to supply such information.
Subregulations 4.1 and 4.2 replace the words him or her, with a reference to 'the analyst,, in order to assist the clarity of the wording of subregulations 29(1) and 29(2).
Subregulation 5.1 amends subregulation 45(5)(f)(ii) to provide that where simultaneous applications are to be subject to a reduction in the evaluation fee payable for those applications additional to the initial application, the sponsor shall offer to pay the full amount of the reduced fee where there are 2 additional such applications, rather than 3.
Subregulation 5.2 amends subregulations 45(6) and (7) to change the evaluation fee reduction applicable to additional simultaneous applications, so that the fee is reduced to zero for only the first 2 such applications instead of the first 3. The schedule of reduced fees applicable to 3 or more additional simultaneous applications is consequently revised and the fees expressed as a total sum of the reduced fees, depending on the number of additional applications.
Subregulations 6.1 to 6.4 include two new organisations in item 8 of Schedule 1 and correct the spelling of the Australian Federation of Homoeopaths (WA) Inc. with consequent relocation of this organisation within the item.
Subregulation 7.1 corrects a grammatical error in the list of therapeutic devices which are not required to be included in the 'registered goods',
Australian Register of Therapeutic Goods as specified in item 3 of Part 1 of Schedule 3.
Subregulation 8.1 inserts a new item 5 in Schedule SA. The item exempts from inclusion in the Australian Register of Therapeutic Goods those therapeutic goods which meet the criteria and conditions listed in columns 2 and 3.
Exempted goods are those which are not for use in a clinical trial and are manufactured to a formulation specified by a public or private hospital or public institution, for use with, or in connection with, patients of the hospital, institution or State/Territory public hospital system, under a contract between the hospital or institution and the manufacturer.
To qualify for the exemption, no equivalent goods must be included in the Australian Register of Therapeutic Goods and the manufacturer must be licensed under Part 4 of the Act to produce goods of that type. The manufacturer is to report details of goods manufactured under this provision to the Secretary on a quarterly basis.
Subregulation 9.1 amends the wording of item 14A of Schedule 9 so that it is the same as item 14 of that schedule, in that it refers to the intention to 'sponsor, a clinical trial rather than 'conduct' such a trial. Items 14 and 14A specify the fees payable for the notification of this activity for drug trials and therapeutic device trials respectively.