Therapeutic Goods (Charges) Regulations (Amendment) 1992 No. 88
EXPLANATORY STATEMENT
STATUTORY RULES 1992 No. 88
Issued by authority of the Minister for Aged, Family and Health Services
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Regulations (Amendment)
The Therapeutic Goods (charges) Act 1989 imposes an annual charge for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods, and an annual charge for licences to manufacture therapeutic goods.
Section 5 of that Act empowers the Governor-General to make regulations prescribing the amounts of those charges.
Background
The amending Regulations:
(a) amend the Therapeutic Goods (Charges) Regulations to correct an anomaly in the annual amount being charged for manufacturers, licences covering the manufacture of single therapeutic goods, and
(b) substitute the words "device" and "feel" with terminology that is more appropriate for the Regulations.
Regulation 2 amends subparagraph 3(2)(b)(iii) of the Charges Regulations to remove the present anomaly whereby an annual licence charge of $1500 is payable for the manufacture of a single sterile product, whereas a charge of $3000 applies for the manufacture of a single non-sterile product. The effect of the amendment will be that the same annual charge of $1500 will be payable by a manufacturer for a licence to manufacture a single therapeutic product, whether or not that product is sterile. Also, the reference to "device" in subparagraph 3(2)(b)(iii) has been amended to correctly refer to "therapeutic device", which is defined in the Therapeutic Goods Act 1989.
Regulation 3 substitutes the word "fee" in paragraphs 4(2)(a) and (b) with the word "charge", in line with the correct terminology used in the Regulations.
Overview
The Therapeutic Goods (Charges) Regulations (Amendment) 1992 No. 88 was enacted to address anomalies in the annual charges for the manufacture of therapeutic goods as stipulated in the Therapeutic Goods (Charges) Act 1989. This amendment was issued by authority of the Minister for Aged, Family and Health Services to rectify inconsistencies in the fees imposed on manufacturers of therapeutic goods, particularly in relation to the distinction between sterile and non-sterile products. The policy objective of these Regulations is to ensure equitable and consistent application of charges, thereby streamlining the regulatory framework for therapeutic goods in Australia. The Regulations correct an anomaly whereby a higher annual charge was applied for the manufacture of single non-sterile products compared to single sterile products, and also update terminology to better align with the definitions provided in the Therapeutic Goods Act 1989.
Scope and Application
The Therapeutic Goods (Charges) Regulations (Amendment) 1992 No. 88 pertains to the Therapeutic Goods (Charges) Act 1989, which imposes annual charges for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods and for licences to manufacture such goods. This Act applies to manufacturers of therapeutic goods and those entities seeking licences to produce these goods within Australia. The Regulations amend the original set to rectify an anomaly in the charges applied for the manufacture of single therapeutic goods, specifically addressing the different charges for sterile and non-sterile products. Additionally, the terminology within the Regulations is updated to ensure consistency and accuracy, replacing instances of "device" with "therapeutic device" where appropriate. The amendments extend to the entire Commonwealth of Australia, affecting all manufacturers and entities involved in the production of therapeutic goods, with the changes being implemented through statutory rules issued under the authority of the Minister for Aged, Family and Health Services.
Key Provisions
The Therapeutic Goods (Charges) Regulations (Amendment) 1992 No. 88 amends the Therapeutic Goods (Charges) Regulations to address an anomaly in the annual charge structure for manufacturers' licences (Reg. 2). It also corrects terminology to align with the definitions used in the Therapeutic Goods Act 1989 (Reg. 3). Under Regulation 2, the previous disparity where a higher annual charge was applied for the manufacture of single non-sterile products compared to sterile products is rectified. Now, regardless of whether a product is sterile or non-sterile, the same annual charge of $1500 applies for a licence to manufacture a single therapeutic product. This amendment ensures that the charging structure is consistent and equitable for all manufacturers. Regulation 3 corrects terminology by substituting the word "fee" with "charge" in paragraphs 4(2)(a) and (b), ensuring consistency with the language used in the Therapeutic Goods Act 1989.
These Regulations impose obligations on manufacturers to ensure they accurately pay the amended annual charges as prescribed. For manufacturers holding a licence to produce therapeutic goods, they are required to be aware of the updated charge rates and ensure compliance with the new requirements. The Regulations mandate that manufacturers who previously paid a higher charge for non-sterile products must now adjust to the uniform annual charge of $1500. Additionally, the use of correct terminology, such as "therapeutic device" instead of "device," ensures clarity and compliance with the legislative framework.
The Therapeutic Goods (Charges) Act 1989 does not explicitly outline specific offences or penalties for non-compliance with the amended charges in the Regulations. However, general provisions within the Act imply that failure to comply with the prescribed charges may result in legal consequences, including potential fines or other penalties as determined by the relevant authorities. The exact penalties would depend on the specific circumstances and could be addressed under the broader legal framework that governs compliance with legislative requirements.