Source: https://www.tga.gov.au/book/export/html/874603
Timestamp: 2019-11-13 19:43:43
Document Index: 128687219

Matched Legal Cases: ['art 2', 'art 1', 'art 2', 'art 1', 'art 2', 'art 4', 'art 1', 'art 2', 'art 4', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2', 'art 1', 'art 2', 'art 2', 'art 1', 'art 2', 'art 2']

The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989 , including the TGA's public health responsibilities.
This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation. This is not an exhaustive list.
For a complete list of all fees and charges and the exact legislative wording, please refer directly to the legislation.
On this page: Annual charges for prescription medicines | Application and evaluation fees for prescription medicines | Requests with single fee | Medicines as components of devices
Annual charges for prescription medicines
Table 1: Annual charges for prescription medicines
Biological medicine $7,270
Item 7(1)(b)(i)(ii)(iii)
Item 7(2)(b)(i)(ii)(iii)
Non-biological medicine (chemical entity) - subsection 3-10 of regulation 8 $4,140 8(2)(a)
Non-biological medicine (chemical entity) - otherwise $3,360 8(2)(b)
Provisionally registered biological medicine $16,400 9(1)(a)
Provisionally registered non-biological medicine $13,400 9(1)(b)
More about chemical entities annual charges
whatever the duration of registration, for medicines containing at least one specified active ingredient:
most prescription medicines that are not biological medicines past the eighth anniversary of an application approval for a:
change to intended patient group.
Application and evaluation fees for prescription medicines
In this section: Standard prescription medicine processes | Priority review pathway for prescription medicines| Provisional approval pathway for prescription medicines
These applications have both an application fee and an evaluation fee.
Table 2: Standard prescription medicine processes
New chemical entity* $48,800 $195,700 Item 2(ba) and Item 4(a)
Extension of indications* $29,100 $116,100 Item 2(bd) and Item 4(b)
Major variations*^ $19,000 $75,700 Item 2(bi) and Item 4(g)
Minor variation applications applied for under section 23 of the Act (Change in formulation, composition, design specifications, type of container or change of trade name)^ $1,120 $4,450 Item 2(bj) and Item 4(h)
Variations to an ARTG entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, applied for under 9D(3) of the Act. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data*^ $1,120 $4,450 Item 2AC and Item 2C
Additional trade name^ $3,080 $12,300 Item 2(bh) and Item 4(d)
New generic product* $18,800 $74,700 Item 2(bg) and Item 4(c)
Extension of indications of a generic medicine to maintain currency with indications already registered to the corresponding innovator product and where clinical and/or bioequivalence data are not required $1,120 $4,450 Item 2(bk) and Item 4(bc)
'The Act' refers to the Therapeutic Goods Act 1989
^the fees are the same for registered and provisionally registered medicines
Priority review pathway for prescription medicines
Table 3: Priority review pathway for prescription medicines
Priority determination of a prescription medicine $12,800 n/a Item 1B
New prescription medicine in the priority pathway $51,700 $207,000 Items 2(bca) and 4(ab)
New indications medicine in the priority pathway $30,800 $123,100 Items 2(bfa) and 4(bd)
Table 4: Provisional approval pathway for prescription medicines
Provisional determination of a prescription medicine $12,800 n/a Item 1AA
Extension of provisional determination $ 4,610 n/a Item 1AB
Provisional registration of a new prescription medicine $48,900 $255,300 Items 1AC(a) and 1AD(a)
Provisional registration of a new indications medicine $29,200 $168,400 Items 1AC(b) and 1AD(b)
Extension of provisional registration $17,600 n/a Item 1AG
Transition from provisional registration to full registration* $29,100 $122,800 Items 1AE and 1AF
These requests have a single fee, instead of an application fee and an evaluation fee.
Table 5: Requests with single fee
Variations to an ARTG entry, applied for under section 9D(3) of the Act, involving the evaluation of only chemistry, quality control or manufacturing data. Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information. $5,570 Item 2B
Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data $1,710 Item 2A(a)
Correction to an ARTG entry $1,710 Item 2A(a)
Notification request $810 Item 2CB
Self-assessable request with no evaluation of data $1,710 Item 2A(a)
Safety-related request with no evaluation of data $1,710 Item 2A(a)
Safety-related request with evaluation of data $5,570 Item 2CA
Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit $2,260 Item 18
This table applies to prescription medicines used as an ancillary component of a medical device.
Table 6: Medicines as components of devices
New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $16,200 $65,300
Item 2(bb)
Item 4(aa)(i)
Item 4(aa)(ii)
New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $32,600 $130,200
Item 2(bc)
Item 4(aa)(iii)
Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $9,680
Item 2(be)(i)
Item 4(bb)(i)(a)
Item 4(bb)(ii)(a)
Extension of indications of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $19,500 $77,400
Item 2(bf)(i)
Item 4(bb)(iii)(a)
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $6,320 $25,100
Item 2(be)(ii)
Item 4(bb)(i)(b),
Item 4(bb)(ii)(b)
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $12,700 $50,600
Item 2(bf)(ii)
Item 4(bb)(iii)(b)
Manufacturing licences have an annual charge.
Table 25: Annual charges for manufacturing licences
Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers $4,680 Item 7(5)(a), Item 7(5)(b), Item 7(5)(c) and Item 7(5)(e)
Manufacturing licence charge for therapeutic device (other therapeutic good) $6,510 Item 7(5)(d)
Applications for Australian manufacturing licences have application, variation and inspection fees.
Table 26: Australian manufacturing licences
Australian manufacturing sites - application fee for a manufacturing licence $790 Item 8(a)
Application for variation of a manufacturing licence $790 Item 8A
Australian manufacturing sites - inspection fee $990/hour/inspector Item 9(a)
Table 27: Overseas manufacturing site inspections
Overseas manufacturing sites - inspection fee $1,390/hour/inspector Item 9(b)
There is no application fee for GMP clearance.
GMP clearance application processing fee (per manufacturer, per site, per sponsor) $650 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $700 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,480 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,180 Item 6AC
There are fees for issuing manufacturing certificates.
Table 29: Issuing manufacturing certificates
Mutual Recognition Agreement certificate $340
You can apply for an export certificate for any medicine.
Table 30: Medicine export certificates
There is an application fee and a processing fee for listed export-only medicines.
Table 31: Listed export-only medicines
Application fee $840 Item 3(b)
Processing fee (variation to an existing listing) $430 Item 2A(c)
You can apply for an export certificate for a medical device (including IVD devices) or OTG.
Table 32: Device export certificates
These fees apply to include a medical device, including IVD device, in the ARTG that is for export only.
Table 33: Export-only devices
Application for inclusion into the ARTG of export only devices $90 Item 1.5(f)
Application for inclusion into the ARTG of export only IVD devices $90 Item 1.5(i)
On this page: Annual charges for manufacturing biologicals | Manufacturing biologicals fees | Annual charges for sponsoring biologicals | Fees for sponsoring biologicals
Annual charges for manufacturing biologicals
There is no annual charge for a manufacturer who only manufactures biologicals [regulation 7(5)(j) Therapeutic Goods (Charges) Regulations 2018 ].
Manufacturing biologicals fees
There is an application fee and various inspection fees for manufacturing biologicals.
Table 34: Manufacturing biologicals fees
Schedule 9A Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,110 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $21,900 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,600 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $680/hour/inspector Item 14
These fees are in Schedule 9A, Therapeutic Goods Regulations 1990 .
Annual charges for sponsoring biologicals
There are annual charges for including a biological in the ARTG.
Table 35: Annual charges for sponsoring biological
Class 1 biological annual charge for ARTG inclusion $680 Regulation 7(3)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,760 Regulation 7(3)(b)
Fees for sponsoring biologicals
Table 36: Fees for sponsoring biologicals
Ingredient or component of a biological to be evaluated under regulation 16GF - evaluation fee $23,900 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,110 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,110 Item 2
Variation application fee - all classes $1,110 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $73,700 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,760 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $147,400 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $239,500 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $34,900 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $17,800 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,760 Item 8A
These fees are in Schedule 9A, Therapeutic Goods Regulations 1990
Table 37: Manufacturing annual charges
Blood and blood components (not HPCs) - primary manufacturing site $163,600 Item 7(5)(f)(i)
Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site $8,050 Item 7(5)(f)(ii)
HPCs manufacturing site $7,040 Item 7(5)(g)
Table 38: Manufacturing fees
Australian manufacturing sites - application fee for a manufacturing licence $1,040 Item 8(b)
Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee $920/inspector/hour Item 9AB
Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee $680/inspector/hour Item 9AC
HPCs - Australian manufacturing site inspection fee $680/inspector/hour Item 9AA
Human tissues that are not biologicals - Australian manufacturing site - inspection fee $680/inspector/hour Item 9ACA
The evaluation fee for blood plasma master files and blood technical master fees depends on the number of pages.
Table 39: Blood plasma and technical master files
1-10 $1,340 Item 9AD(a)
11-50 $11,400 Item 9AD(b)
51-100 $25,600 Item 9AD(c)
101-1000 $34,400 Item 9AD(d)
1001-3000 $53,700 Item 9AD(e)
3001-4000 $71,500 Item 9AD(f)
>4000 $87,300 Item 9AD(g)
This fee applies to human blood, blood components and HPCs and human tissues not regulated as biologicals.
This fee in Schedule 9, Therapeutic Goods Regulations 1990
Table 56: Annual charges
All classes of IVD (excluding Class 4 in-house IVDs) $680 7(4)(e)
Class 4 in-house IVDs n/a 7(4)(f)
Table 57: Notification fee
Notification by a laboratory of its Class 1, Class 2 or Class 3 in-house IVDs $1,040 Item 1.17
These fees are to apply to include an IVD in the ARTG. Application audit assessment fees are often payable as well.
Table 58: Application fees
Application for inclusion into the ARTG of all classes of IVD, including Class 4 in-house IVDs (excluding export only IVD devices) $1,040 Therapeutic Goods (Medical Devices) Regulations 2002 ,
Schedule 5 Part 1,
Item 1.5(h)
Variation to an ARTG inclusion entry $460 Therapeutic Goods Regulations 1990 ,
Schedule 9 Part 2 Item 2A(g)
These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990
This fee is for applicants seeking Priority Review designation for an application to include an IVD in the ARTG.
Table 59: Application for medical devices (priority applicant) determination
Medical devices (priority applicant) determination in relation to a medical device (including an IVD) $10,000 Item 1.5A
Table 60: Application audit assessment fees
Class 1, Class 2 and Class 3 IVDs $6,990 Item 1.14A
Class 4 in-house IVDs $64,700 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $15,700 Item 1.14C
Table 61: Application for conformity assessment
This fee is for applicants seeking Priority Review designation for an application for TGA conformity assessment of an IVD.
Table 62: Application for conformity assessment (priority applicant) determination
Conformity assessment (priority applicant) determination in relation to a medical device (including an IVD) $10,000 Item 1.1A
Table 63: Initial assessment of conformity assessment
Full quality management system inspection: described in Schedule 3, Part 1 $30,400 Item 1.9A(a)
Design examination: described in Schedule 3, Clause 1.6 $64,700 Item 1.9A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $15,700 Item 1.9A(c)
Type examination: described in Schedule 3, Part 2 $41,900 Item 1.9A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $26,700 Item 1.9A(f)
Full quality management system inspection: described in Schedule 3, Part 1 $30,400 Item 1.3A(a)
Design examination: described in Schedule 3, Clause 1.6 $64,700 Item 1.3A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $15,700 Item 1.3A(c)
Type examination: described in Schedule 3, Part 2 $41,900 Item 1.3A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $26,700 Item 1.3A(f)
Table 65: Other IVD conformity assessment fees
Supplementary additional assessment in addition to assessment mentioned in item 1.2, 1.3A, 1.9A or 1.10A [item 2.1(b), Schedule 5] $430/assessor hour Item 1.12
Surveillance assessment for conformity assessment certificate under Schedule 3, Part 1 or 4 $8,850 Item 1.2(b)
Assessment of changes to IVD or QMS for applicable IVD 60% of the relevant 'initial assessment' fee* under item 1.9A Item 1.10A(a)
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $6,990 Item 1.14A
*: for relevant 'initial assessment' fees
Table 66: Annual charges
Listed OTG: tampons and disinfectants $860
Item 7(1)(c)(iii) and Item 7(2)(c)(iii)
Registered OTG - disinfectants $1,670
Item 7(1)(a)(iii) and Item 7(2)(a)(iii)
Table 67: Listed OTG fees
Application fee $460 Item 3(a)
Variation fee $460 Item 2A(f)
Fee for evaluating documents and information relating to the safety of a listed therapeutic device $18,600 Item 9C
Table 68: Registered OTG fees
Low level registered device – disinfectant variation initial evaluation fee $3,740 Item 6B
Clinical trial notification (CTN) $370 Item 14A(a)
High level registered device - application fee $4,440 Item 2(c)
High level registered device - variation processing fee $460 Item 2A(e)
High level device – variation manufacturing and/or quality control – initial evaluation $9,270 Item 7(b)
These fees are in Therapeutic Goods Regulations 1990
Table 69: Miscellaneous fees
This fee is in Schedule 9, Therapeutic Goods Regulations 1990
These fees for clinical trials of unapproved medicines.
Table 70: Unapproved medicines
Clinical trial notification (CTN) $370 Item 14(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 14(b)
Clinical trial exemption (CTX) - 30 day evaluation $1,760 Item 1(a)
Clinical trial exemption (CTX) - 50 day evaluation $21,900 Item 1(b)
These fees for clinical trials of unapproved biologicals.
Table 71: Unapproved biologicals
Clinical trial notification (CTN) $370 Item 17(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 17(b)
Clinical trial exemption (CTX) $26,600 Item 16
These fees for clinical trials of unapproved medical devices and IVDs.
Table 72: Unapproved medical devices (including IVDs)
Clinical trial notification (CTN) $370 Item 1.8
Clinical trial exemption (CTX) $18,600 Item 1.7
These fees for clinical trials of unapproved other therapeutic goods.
Table 73: Unapproved other therapeutic goods
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 14A(b)
Clinical trial exemption (CTX) - with no clinical studies to demonstrate safety and effectiveness $2,800 Item 1(d)
Clinical trial exemption (CTX) - with clinical studies to demonstrate safety and effectiveness $18,600 Item 1(c)
'Specified media' is defined in section 42B of the Therapeutic Goods Act 1989 .
Table 74: Specified media excluding broadcast media
Advertisement* intended for publication in the classified advertisements column of a newspaper or other printed publication $130 Item 17(a)(iv)
Advertisement* of 100 words or less $260 Item 17(a)(i)
Advertisement* of more than 100 words but of 300 words or less $310 Item 17(a)(ii)
Advertisement* of more than 300 words (including an advertorial) $480 Item 17(a)(iii)
Moving cinema advertisement* of 150 seconds or less in length, with up to 3 variations of the advertising concept, for the same product. $1,210 Item 17A(a)(i)
Still cinema advertisement* (including outdoor media) of 100 words or less $260 Item 17A(a)(vi)(A)
Still cinema advertisement* (including outdoor media) of more than100 words but of 300 words or less $310 Item 17A(a)(vi)(B)
Still cinema advertisement* (including outdoor media) of more than 300 words. $480 Item 17A(a)(vi)(C)
Advertisement* for re-approval of an identical advertisement whose approval number has expired 50% of applicable fee, including any fee for additional hours Item 17(d) and Item 17A(d)
Advertisement* for approval of a variation to an advertisement whose approval number has not expired. 50% of applicable fee, including any fee for additional hours Item 17(e) and Item 17A(e)
Each additional hour or part thereof after the first processing hour, in addition to the specified fee for the advertisements marked with an asterisk (*) in this table. $210 Item 17(b) and Item 17A(b)
Fees are in in Schedule 9, Therapeutic Goods Regulations 1990
'Broadcast media' is defined in section 42B of the Therapeutic Goods Act 1989 .
Certain broadcast media, for example the internet and certain mobile communications, are excluded from this definition for pre-approval of advertisements for therapeutic goods, by Regulation 5BA, Therapeutic Goods Regulations 1990 .
Table 75: Broadcast media
Television advertisement* of 150 seconds or less in length with up to 3 variations of the advertising concept for the same product $1,210 Item 17A(a)(i)
Television advertisement* for a retail outlet that is intended to be broadcast on 1 regional station only in that station’s regional area $640 Item 17A(a)(ii)
$920 for first minute of script and $260 for each additional minute or part minute
Item 17A(a)(iii) (A) and Item 17(A)(a)(iii)(B)
Radio Advertisement* including up to 6 variations of the advertising concept for the same product $450 Item 17A(a)(iv)
Radio Advertisement* that is intended to be broadcast in a regional area only including up to six variations of the advertising concept for the same product $320 Item 17A(a)(v)
Advertisement* that is a minor change to an approved advertisement sought more than 3 months after the date of approval. (There is no charge when sought 3 months or less.) 50% of applicable fee, including any fee for additional hours Item 17A(c)
Advertisement* requiring re-approval of an identical advertisement whose approval number has expired. 50% of applicable fee, including any fee for additional hours Item 17A(d)
Advertisement* requiring approval of a variation to an advertisement whose approval number has not expired 50% of applicable fee, including any fee for additional hours Item 17A(e)
Each additional hour or part thereof after the first processing hour, in addition to the specified fee for the advertisements marked with an asterisk (*) in this table. $210 Item 17A(b)
Fees are in Schedule 9 to the Therapeutic Goods Regulations 1990 .
To maintain an annual charge exemption, sponsors are able to self-declare that their product had no turnover. Self-declarations must be submitted to the TGA between 1 July and 22 July each year or it will be assumed that the product generated greater than $0 turnover.
Late notice declarations made before 15 September under regulation 43AAE(2) of the Therapeutic Goods Regulations 1990 attract a late declaration fee.
Table 76: Fees related to annual charge exemption (ACE) scheme
If the declaration relates to not more than 5 entries in the ARTG $430
Schedule 9 Part 2 Item 3AB(a)
Schedule 9A Part 2 Item 3A(a)
$430 for first 5 entries + $50 for each additional entry
Schedule 9 Part 2 Item 3AB(b)
Schedule 9A Part 2 Item 3A(b)
Fees are in the Therapeutic Goods Regulations 1990
Table 77: Fees related to a request to revoke an ARTG entry cancellation
Therapeutic Goods (Medical Devices) Regulations 2002: Schedule 5, Part 1 Item 1.6A(a) and Item 1.6B(a)
Therapeutic Goods Regulations 1990: Schedule 9, Part 2 Item 6BA(a) and Item 6BB(a)
Therapeutic Goods Regulations 1990: Schedule 9A, Part 2 Item 16A(a) and Item 16B(a)
Therapeutic Goods (Medical Devices) Regulations 2002 : Schedule 5, Part 1 Item 1.6A(b) and Item 1.6B(b)
Therapeutic Goods Regulations 1990 : Schedule 9, Part 2 Item 6BA(b) and Item 6BB(b)
Therapeutic Goods Regulations 1990 : Schedule 9A, Part 2 Item 16A(b) and Item 16B(b)
Fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990
V1.0 Original publication for the financial year July 2019 to June 2020 Regulatory Services and Drug Control Branch 01/07/2019
V1.1 Inclusion of export only IVD device application fee (table 33) and minor editorial changes Regulatory Services and Drug Control Branch July 2019