Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(regulation 43)
Part 1 -- Interpretation of table
In this table:
"major variation" , for a biological, means a change to the entry of the biological in the Register for any of the following, other than a change that would result in the biological becoming separate and distinct from other biologicals:
(a) a change requiring submission and evaluation of clinical data;
(c) a new strength;
(d) a new route of administration;
(e) a change in the intended patient group;
(f) a change in dosage.
"minor variation" , for a biological, means a change to the entry of the biological in the Register that requires the evaluation of quality and manufacturing information, other than a change that is a major variation for the biological or that would result in the biological becoming separate and distinct from other biologicals.
Item | Matter | Fee |
1 | Application for inclusion of a Class 1 biological in the Register for paragraph 32DA(2)(d) of the Act | $1,231 for each application |
2 | Application for inclusion of a Class 2, Class 3 or Class 4 biological in the Register for paragraph 32DDA(2)(b) of the Act | $1,231 for each application |
2AA | Application fee for the purposes of paragraph 32DCA(2)(c) of the Act for an application to include an export only biological in the Register | $1,231 for each application |
2A | Application fee for the purposes of paragraph 32DEA(3)(d) of the Act for a biologicals (priority applicant) determination in relation to a biological | $14,697 |
3 | Application for a manufacturing licence for paragraph 37(1)(g) of the Act | $1,231 for each application |
3A | Fee for a notice and declaration under subregulation 43AAE(2) relating to an exemption from liability to pay an annual charge for inclusion of a biological in the Register for a financial year: |
|
| (a) if the notice and declaration relate to not more than 5 entries in the Register | $474 |
| (b) if the notice and declaration relate to 6 or more entries in the Register | $474 for the first 5 entries plus $54 for each additional entry |
4 | Evaluation of a Class 2 biological for inclusion in the Register for subsection 32DI(1) of the Act: |
|
| (a) for a biological in relation to which a biologicals (priority applicant) determination is in place | $85,630 for each evaluation |
| (b) in any other case | $81,922 for each evaluation |
5 | Evaluation of a Class 3 biological for inclusion in the Register for subsection 32DI(1) of the Act: |
|
| (a) for a biological in relation to which a biologicals (priority applicant) determination is in place | $171,683 for each evaluation |
| (b) in any other case | $163,953 for each evaluation |
6 | Evaluation of a Class 4 biological for inclusion in the Register for subsection 32DI(1) of the Act: |
|
| (a) for a biological in relation to which a biologicals (priority applicant) determination is in place | $277,423 for each evaluation |
| (b) in any other case | $266,384 for each evaluation |
7 | Evaluation of an ingredient or component of a biological under regulation 16GF, for use in multiple biologicals (for which application for registration would later be made) | $26,660 for each evaluation |
8 | Application under subsection 9D(3AA) or (3A) of the Act to vary the entry of a biological in the Register | $1,231 for each application |
8A | Evaluation of an application under subsection 9D(3AA) of the Act to vary the entry of a biological in the Register | $7,512 for each evaluation |
9 | Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 2 biological in the Register | $7,512 for each evaluation |
10 | Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a minor variation | $19,752 for each evaluation |
11 | Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a major variation | $38,857 for each evaluation |
11A | Application fee for processing an application for consent under section 14 or 14A of the Act: |
|
| (a) for an application relating to goods that are biologicals to which a single entry in the Register relates | $540 (for all the goods to which the application relates) |
| (b) for an application relating to goods that are biologicals to which both of the following apply: (i) there are separate entries in the Register in relation to the goods; (ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods | $540 for the first entry plus $108 for each additional entry |
12 | Inspection fee--initial manufacturing audit (Australia and overseas) for paragraphs 32DE (1) (e), 38(1)(c) and 58(3)(b) of the Act | $24,285 for each inspection |
13 | Inspection fee--subsequent Manufacturing Audit (Australia and overseas) for paragraphs 41 (1)(f) and 58(3)(b) of the Act | $18,457 for each inspection |
14 | Inspection fee--in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia | $755 for each hour of preparation by each inspector |
15 | Inspection fee--in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia | Amount of costs and reasonable expenses of travel by each inspector, including costs for accommodation and allowance outside Australia |
16 | Evaluation fee for subsection 32CK(4) of the Act | $29,574 for each evaluation |
16AA | Fee for the purposes of paragraph 32CK(9A)(e) of the Act, for a request under subsection 32CK(9A) of the Act to vary the biological specified in an approval to use the biological solely for experimental purposes in humans, or to vary the conditions of such an approval | $8,069 |
16A | Application fee for a request, under subsection 32GD(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register: |
|
| (a) if the request relates to one entry; | $173 |
| (b) if the request relates to more than one entry | $173 for the first entry plus $54 for each additional entry |
16B | Application fee for a request, under subsection 32GDA(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register: |
|
| (a) if the request relates to one entry; | $173 |
| (b) if the request relates to more than one entry | $173 for the first entry plus $54 for each additional entry |
17 | Fee for notification required under item 3 of Schedule 5A for a biological to which that Schedule applies: |
|
| (a) of intention to sponsor a clinical trial at a trial site using a biological | $410 |
| (b) for each notification of an additional trial site or additional trial sites | $410 |