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MP1/2013 Determinations/Health as amended, taking into account amendments up to Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2)
Administered by: Health
Registered 17 Oct 2017
Start Date 30 Sep 2017
Date of repeal 01 Jan 2018
Repealed by Therapeutic Goods (Manufacturing Principles) Determination 2018

 

Commonwealth Coat of Arms

Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2013

made under section 36 of the

Therapeutic Goods Act 1989

Compilation No. 2

Compilation date:                             30 September 2017

Includes amendments up to:            F2017L01289

Registered:                                       

 

 

 

 

 

 

Prepared by the Department of Health

About this compilation

 

This compilation

This is a compilation of the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 that shows the text of the law as amended and in force on 30 September 2017 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 


Citation

1.      This Determination may be cited as the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013.

Commencement

2.      This Determination commences on 31 May 2013.

[Note: see Legislative Instruments Act 2003 section 12.]

Application

3.      The manufacturing principles applicable to specific therapeutic goods are set out in the following Divisions:

a.         Division 1 – Therapeutic Goods including Active Pharmaceutical Ingredients (API) and Sunscreens, but not Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma, Haematopoietic Progenitor Cells, Therapeutic Devices and Medical Devices

b.         Division 2 –Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma and Haematopoietic Progenitor Cells

c.         Division 3 – Therapeutic Devices

Note: The manufacturing principles applicable to therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1, and not those set out in Division 2.

Interpretation

4.      In this Determination, unless the contrary intention appears:

“active pharmaceutical ingredients (API)” means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the production of a medicine, becomes an active ingredient of that medicine.  These substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

“AS ISO 13485-2003” means the document entitled “AS ISO 13485-2003 Medical devices – Quality management systems – Requirements for Regulatory purposes published by the International Standards Organisation.

biological” has the same meaning as in the Act.

“blood” means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.

“blood components” means therapeutic components of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration and freezing, but not including haematopoietic progenitor cells.

“EN 556” means the document entitled EN 556: 1994 “Sterilization of medical devices – requirements for medical devices to be labelled ‘Sterile’, published by the European Standards Committee (CEN) Central Secretariat.

haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.

“medicine” has the same meaning as in the Act.

“plasma” means plasma, separated from human donor blood, intended for a number of purposes including the production of further blood components, the production of which is required to be licensed under Chapter 3, Part 3-3 of the Act.

“Register” has the same meaning as in the Act.

standard” has the same meaning as in the Act.

 “the Act” means the Therapeutic Goods Act 1989, as amended from time to time.

the Australian Code of Good Manufacturing Practice” means the document titled: “Australian Code of Good Manufacturing Practice for Human Blood, Blood Components, Human tissues and Human cellular therapy products” dated April 2013 and published by the TGA on its website.

[Note: Clause 14 provides transitional arrangements in relation to the application of the Australian Code of Good Manufacturing Practice between the commencement of this Determination and up to and including 31 May 2014].

“the Code” means the document titled “PIC/S Guide for Good Manufacturing Practice for Medicinal Products – 15 January 2009”, PE 009-8, published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), dated 15 January 2009, except for the following Annexes of that document:

a.         Annex 4 (titled Manufacture of Veterinary Medicinal Products Other than Immunologicals); and

b.         Annex 5 (titled Manufacture of Immunological Veterinary Medicinal Products); and

c.         Annex 14 (titled Manufacture of Products Derived from Human Blood or Human Plasma) of that document.

“Technical Master File”, for a therapeutic good, means:

  1. compilations of scientific and technical data provided by a manufacturer which include a description of the steps of manufacture that is consistent with the description of steps of manufacture identified in the document entitled "Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells", published by the TGA on its website; and

b.      detailed scientific and technical data or information that must satisfy the Secretary that:

    1. the blood or blood components, manufactured using the steps of manufacture mentioned in paragraph (a), will meet Therapeutic Goods Order No. 81 – Standards for Blood and Blood Components; or
    2. the haematopoietic progenitor cells derived from cord blood manufactured using the steps of manufacture mentioned in paragraph (a) will meet the standard set out in the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017; and
    3. donor selection, testing and the process for minimising infectious disease transmission via therapeutic goods that are human blood and blood components will meet the requirements of Therapeutic Goods Order No. 88 - Standards for donor selection, testing and minimising infectious disease transmission through therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.

“Therapeutic device” has the same meaning as in the Act.

“TGA” means the Therapeutic Goods Administration, a business unit of the Department of Health and Ageing.


Division 1 – Manufacturing principles for therapeutic goods including Active Pharmaceutical Ingredients (API) and Sunscreens, but not Blood and Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma, Haematopoietic Progenitor Cells therapeutic devices and medical devices

Note: The manufacturing principles applicable to therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1, and not those set out in Division 2.

(1)          This Division applies to the manufacture of therapeutic goods including API and Sunscreens, other than:

(a)      blood and blood components, plasma and haematopoietic progenitor cells;

(b)     biologicals (except things that comprise or contain live animal cells, tissues or organs);

(c)      therapeutic devices;

(d)     medical devices.

(2)          Subject to subclause (3), manufacturers of therapeutic goods in Australia to which this Division applies must follow the procedures and requirements set out in the Part of the Code, and the Annex to the Code that applies to the particular goods being manufactured. 

(3)          Where the Code provides that a procedure or requirement ‘should’ be followed, manufacturers of therapeutic goods in Australia must follow that procedure or requirement in order to comply with the Code, unless in  relation to that particular procedure or requirement:

(a)      the manufacturer demonstrates, to the satisfaction of the TGA, that the failure to adopt that procedure or requirement:

                                                  i.      will not increase the risk that the goods produced as a result will or could cause  harm or injury to any person, or will or could  potentially have the effect of causing or contributing to such harm; and

                                                ii.      will not increase the risk of the therapeutic goods in question failing to comply with, where applicable both the standard for that therapeutic good and the conditions of the listing or registration for that therapeutic good; and

                                              iii.      will not depart from  the record keeping requirements contained in the Code; or

(b)     where an alternative procedure to the procedure or requirement set out under an applicable Part of, or Annex to, the Code has been adopted, the manufacturer demonstrates, to the satisfaction of the TGA, that:

                                                  i.      the alternative procedure will not result in the production of therapeutic goods that could increase the risk of harm or injury to any person or will or could  potentially have the effect of causing or contributing to such harm; and

                                                ii.      the alternative procedure will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for that therapeutic good and the conditions of the listing or registration; and

                                              iii.      will not depart from the record keeping requirements contained in the Code.

(4)          For the purposes of subclause (2), the word “apply” does not include the application, to particular therapeutic goods being manufactured, of an Annex that is stated in the Code to be ‘voluntary’.

Division 2 – Manufacturing principles for Blood, Blood Components, Plasma, Biologicals (except things that comprise or contain live animal cells, tissues or organs) and Haematopoietic Progenitor Cells

(5)          This Division applies to the manufacture of blood, blood components, plasma, biologicals (except things that comprise or contain live animal cells, tissues or organs) and haematopoietic progenitor cells.

(6)          A manufacturer of blood, blood components, plasma and haematopoietic progenitor cells must lodge a Technical Master File with an application for a licence under Chapter 3, Part 3-3 of the Act.

(7)          Blood, blood components, plasma and haematopoietic progenitor cells must be manufactured:

(a)    in compliance with applicable requirements of the Australian Code of Good Manufacturing Practice; and

(b)   in a manner consistent with the relevant Technical Master File lodged for the goods with the TGA by the manufacturer.

(8)          Biologicals (except things that comprise or contain live animal cells, tissues or organs) must be manufactured in compliance with applicable requirements of the Australian Code of Good Manufacturing Practice.

(9)          Where the Australian Code of Good Manufacturing Practice provides that a procedure or requirement ‘should’ be followed, manufacturers of therapeutic goods in Australia must follow that procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.

(10)      A blood processing plant that processes plasma collected from donors in Australia for products that are or will be used in Australia (the Australian product) may only be used to process plasma collected from a source outside Australia if, for that source:

(a)    a plasma master file, prepared in accordance with the requirements of the European Agency for the Evaluation of Medicinal Products document entitled "Guideline on the scientific data requirements for a plasma master file (PMF) EMEA/CPMP/BWP/3794/03, revision 1(2006)" has been submitted to the Secretary by the licensee of the relevant blood processing plant; and

(b)   the Secretary has advised the licensee of the plant that, based upon the plasma master file submitted for those goods, and having taken into account the plant's processes, the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.

(11)      The failure of a manufacturer in Australia of therapeutic goods, to which this Division applies, to follow a particular procedure or requirement set out in an applicable Part of the Australian Code of Good Manufacturing Practice will constitute a failure to comply with the Australian Code of Good Manufacturing Practice unless in relation to that particular procedure or requirement:

(a)      the manufacturer demonstrates, to the satisfaction of the TGA, that the failure to adopt that procedure or requirement:

                                       i.      will not increase the risk that the goods produced as a result will or could cause  harm or injury to any person, or will or could potentially have the effect of causing or contributing to such harm; and

                                     ii.      will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for that therapeutic goods and to the conditions of registration for that therapeutic good; and

                                   iii.      will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice; or

(b)      where an alternative procedure to the procedure or requirements set out under and applicable part of the Australian Code of Good Manufacturing Practice has been adopted, the manufacturer demonstrates, to the satisfaction of the TGA, that:

                                       i.      the alternative procedure will not increase the risk that the goods produced as a result will or could cause  harm or injury to any person, or will or could  potentially have the effect of causing or contributing to such harm; and

                                     ii.      the alternative procedure will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for that therapeutic goods and the conditions of  registration for that therapeutic good; and

                                   iii.      will not depart from the record keeping requirements contained in the Australian Code of Good Manufacturing Practice.

Division 3 – Therapeutic Devices

(12)      In this Division, the following therapeutic devices must be manufactured in compliance with an approved quality assurance system as follows:

(a) for a therapeutic device, other than a device incorporating human tissue

                                       i.      if the therapeutic device must be listed in the Register, it must be manufactured in compliance with AS ISO 13485-2003 other than clause 7.3 (Design and Development); or

                                     ii.      if the therapeutic device must be registered in the Register , it must be manufactured in compliance with AS ISO 13485-2003; and

                                   iii.      if the therapeutic device is labelled ‘Sterile”, it must also be manufactured in compliance with EN 556.

Transitional arrangements for goods mentioned in Division 2

(13)      From the commencement of this Determination up to and including 31 May 2014 (the transition period), where Division 2 of this Determination requires a manufacturer to comply with the Australian Code of Good Manufacturing Practice:

(a)   a manufacturer may choose to comply with either:

                                  i.          the requirements of the document titled: “Australian Code of Good Manufacturing Practice for Human Blood and Tissues” published in the Commonwealth of Australia Gazette, No. S 518, Thursday, 28 September 2000; or

                                ii.          the requirements of both:

a.       The document titled: “Australian Code of Good Manufacturing Practice for Human Blood, Blood Components, Human Tissues and Human Cellular Therapy products ”; dated April 2013 (published by the TGA on its website),  and

b.      Therapeutic Goods Order No. 88  Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products; and

Note 1: Therapeutic Goods Order No. 88 Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products will apply, from 31 May 2014, to human blood and blood components, human tissues and cellular therapy products that are collected from a donor, or subjected to any other manufacture, on or after 31 May 2014.  Before 31 May 2014, compliance with Therapeutic Goods Order No.88 is voluntary.

Note 2:  If a person wishes to begin complying with the Australian Code of Good Manufacturing Practice (2013) before 31 May 2014, the person must also ensure that the requirements of Therapeutic Goods Order No. 88 is or has been observed in the manufacture of their goods, as these are intended to apply together.

(b)   during the transition period, a reference in this Determination to the Australian Code of Good Manufacturing Practice means the document or documents with which the manufacturer has chosen to comply, being either the document referred to in subparagraph (i) of this clause or the documents referred to in subparagraph (ii) of this clause.

(14)      To avoid doubt, after 31 May 2014, where this Determination requires a manufacturer to comply with the Australian Code of Good Manufacturing Practice, a manufacturer must comply with the requirements of the document titled: “Australian Code of Good Manufacturing Practice for Human Blood, Blood Components, Human Tissues and Human Cellular Therapy products” dated April 2013 (published by the TGA on its website).

Note:  From 31 May 2014, Therapeutic Goods Order No. 88 Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products will also apply and manufacturers must comply with this Order.

 


Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history. 

Endnote 2—Abbreviation key

 

o = order(s)

ad = added or inserted

Ord = Ordinance

am = amended

orig = original

amdt = amendment

par = paragraph(s)/subparagraph(s)

c = clause(s)

    /sub‑subparagraph(s)

C[x] = Compilation No. x

pres = present

Ch = Chapter(s)

prev = previous

def = definition(s)

(prev…) = previously

Dict = Dictionary

Pt = Part(s)

disallowed = disallowed by Parliament

r = regulation(s)/rule(s)

Div = Division(s)

 

exp = expires/expired or ceases/ceased to have

reloc = relocated

    effect

renum = renumbered

F = Federal Register of Legislation

rep = repealed

gaz = gazette

rs = repealed and substituted

LA = Legislation Act 2003

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

    effect

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

    cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

 

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Manufacturing Principles)  Determination No. 1 of 2013

28 May 2013 (see F2013L00855)

31 May 2013

 

Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.1)

9 May 2017 (see F2017L00509)

10 May 2017

 

Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.2)

28 September 2017 (see F2017L01289)

30 September 2017

 

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 3

s 4

Div1, heading

Div1,subc(1), par(b)

Div1, subc(2)

Div2, heading

Div2, subc(5)

Div2, subc(8)

am F2017L00509

am F2017L01289

am F2017L00509

am F2017L00509

rs F2017L00509

am F2017L00509

am F2017L00509

am F2017L00509