Proposal for a Council Decision on the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
Date: 2010-05-31
Institutions: European Commission
Subjects: Australia, Community certification, EC conformity marking, agreement (EU), medicinal product, mutual recognition principle, quality label, ratification of an agreement, revision of an agreement

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EUROPEAN COMMISSION 

Brussels, 31.5.2010 
COM(2010)270 final 

2010/0146 (NLE) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of the Agreement between the European Union and Australia 
amending the Agreement on mutual recognition in relation to conformity assessment, 
certificates and markings between the European Community and Australia 

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EXPLANATORY MEMORANDUM 

I. 

1. 

THE AMENDMENT 

Background 

The  Agreement  between  the  European  Community  and  Australia  (‘the  Parties’)  on  mutual 
recognition in relation to conformity assessment, certificates and markings1 (hereinafter ‘the 
Agreement  on  Mutual  Recognition’)  entered  into  force  on  1  January  19992.  With  a  view  to 
further improving and simplifying the functioning of the Agreement on Mutual Recognition, 
the Parties have decided to amend some of its provisions. 

On the basis of the negotiating directives included in the specific decision of the Council of 
21  September  1992  authorising  the  Commission  to  negotiate  agreements  between  the 
European Economic Community and certain third countries on mutual recognition relating to 
conformity  assessment,  as  amended  by  the  specific  decisions  adopted  by  the  Council  on  26 
May 1997 and 8 July 2002, the Commission has negotiated and initialled an Amendment to 
the Agreement on Mutual Recognition (hereinafter ‘the Amendment’). 

The  text  of  the  Amendment  is  attached  to this  proposal.  The  Commission  proposes  that  the 
Council authorise the signature of the Amendment on behalf of the Union. 

The Agreement between the European Community and New Zealand on mutual recognition 
in  relation  to  conformity  assessment3  is  in  effect  identical  to  the  Agreement  on  Mutual 
Recognition  with  Australia.  A  parallel  Agreement  amending  the  Agreement  with  New 
Zealand will be proposed. 

2. 

Assessment of the Amendment 

The amendments are intended to allow greater flexibility in the structure of Sectoral Annexes 
to  the  Agreement  on  Mutual  Recognition,  to  remove  unnecessary  restrictions  on  trade 
between  the  Parties,  to  reduce  the  administrative  burden  related  to  management  of  the 
Agreement and to facilitate and clarify the operation of the Agreement.  

In  addition,  the  Sectoral  Annexes  on  medicinal  products  GMP  inspection  and  batch 
certification  and  on  medical  devices  have  been  superseded  by  changes  in  technical  and 
administrative practice and by changes in the organisations listed therein, and the opportunity 
has been taken to revise them.  

There are no financial implications to this proposal. The Amendment will be published in the 
Official Journal of the European Union. 

A detailed assessment of the Amendment follows. 

1. 

1 
2 
3 

In order to remove unnecessary restrictions on trade, the restriction in Article 4 of the 
application  of  the  Agreement  to  industrial  products  that  originate  in  the  Parties 
according  to  non-preferential  rules  of  origin  will  be  deleted.  As  amended,  the 

OJ L 229, 17.8.1998, p. 3. 
OJ L 5, 9.1.1999, p. 74. 
Ibid., p. 62. 

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2. 

3. 

4. 

5. 

6. 

7. 

8. 

Agreement  on  Mutual  Recognition  will  apply  to  all  products  covered  by  it, 
irrespective of their origin. 

The  references  to  the  Chair  of  the  Joint  Committee  will  be  deleted  from  Articles  8 
and  12,  in  order  to  reflect  the  fact  that  the  Joint  Committee  is  co-chaired  by  the 
Parties.  

In  order  to  simplify  operation  of  the  Agreement  on  Mutual  Recognition,  a  simpler 
procedure  for  the  recognition,  withdrawal  of  recognition  and  suspension  of 
conformity assessment bodies will be set up in Article 12. As a result, a decision by a 
designating  authority  to  designate  or  withdraw  designation  of  a  conformity 
assessment  body  will  no  longer  need  to  be  given  effect  by  an  amendment  to  a 
Sectoral  Annex;  the  need  for  the  Joint  Committee  to  take  action  will  be  limited  to 
cases that have been contested by the other Party under Article 8.  

In  order  to  make  timely  adaptations  to  the  Sectoral  Annexes  to  take  account  of 
technical  progress  and  other  factors  such  as  enlargement  of  the  European  Union, 
Article 12 will also be amended in order to explicitly empower the Joint Committee 
to amend the Sectoral Annexes in areas other than to give effect to the decision by a 
designating authority to designate or withdraw designation of a particular conformity 
assessment body, and also to adopt new Sectoral Annexes.  

Article 3 will be amended in order to reflect the changes to Article 12 and to allow 
greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual 
Recognition. 

The wording of Articles 6, 7, 8, 9 and 15, and of paragraphs 9 and 10 of the Annex, 
have been changed in order to reflect the amendments to Article 12.  

The  Sectoral  Annex  on  medicinal  products  GMP  inspection  and  batch  certification 
has  been  revised  to  take  account  of  developments  in  technical  and  administrative 
practice, changes introduced by the Amendment to the main body of the Agreement 
on  Mutual  Recognition,  updates  in  the  organisations  listed,  and  changes  to  the 
Parties’  legislation  affecting  this  sector.  The  principle  of  operation  of  this  Sectoral 
Annex remains unchanged. 

The  Sectoral  Annex  on  medical  devices  has  been  revised  to  take  account  of 
developments  in  technical  and  administrative  practice,  changes  introduced  by  the 
Amendment to the main body of the Agreement on Mutual Recognition, updates in 
the organisations listed, and changes to the Parties’ legislation affecting this sector. 
The principle of operation of this Sectoral Annex remains unchanged. 

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3. 

Relations with EFTA/EEA Member Countries 

In accordance with the information and consultation procedures set out in the Agreement on 
the  European  Economic  Area  and  Protocol  12  to  that  Agreement,  the  Commission  has 
informed EFTA/EEA Member Countries of progress in the negotiations and the final result.  

II. 

THE PROPOSAL FOR A COUNCIL DECISION 

The  Agreement  between  the  European  Union  and  Australia  amending  the  Agreement  on 
mutual  recognition  in  relation  to  conformity  assessment  between  the  European  Community 
and Australia was signed by the Commission on [ ]. 

The  Commission  therefore  proposes  that  the  Council,  with  the  consent  of  the  Parliament, 
adopts the attached Decision on the conclusion of the amendment to the Agreement. 

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2010/0146 (NLE) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of an Agreement between the European Community and Australia 
amending the Agreement on mutual recognition in relation to conformity assessment, 
certificates and markings between the European Community and Australia 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)thereof, 

Having regard to the proposal from the Commission, 

Having regard to the consent of the European Parliament4, 

Whereas: 

(1) 

(2) 

The  Agreement  on  mutual  recognition  in  relation  to  conformity  assessment, 
the  European  Community  and  Australia5 
certificates  and  markings  between 
(hereinafter ‘the Agreement on Mutual Recognition’) entered into force on 1 January 
19996. 

In accordance with Council Decision 2010/XXX of [...]7, the Agreement between the 
European  Union  and  Australia  amending  the  Agreement  on  mutual  recognition  in 
relation  to  conformity  assessment  between  the  European  Community  and  Australia 
(hereinafter  referred  to  as  ‘the  Agreement’)  was  signed  by  the  Commission  on  [  ], 
subject to its conclusion at a later date. 

(3) 

The Agreement should be concluded, 

HAS ADOPTED THIS DECISION: 

Article 1 

The  Agreement  between  the  European  Union  and  Australia  amending  the  Agreement  on 
mutual  recognition  in  relation  to  conformity  assessment,  certificates  and  markings  between 
the European Community and Australia (hereinafter referred to as ‘the Agreement’) is hereby 
concluded. 

4 
5 
6 
7 

OJ C […], […], p. […]. 
OJ L 229, 17.8.1998, p. 3. 
OJ L 5, 9.1.1999, p. 74. 
OJ L […], […], p. […]. 

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The text of the Agreement to be concluded is attached to this Decision. 

Article 2 

The President of the Council shall designate the person empowered to proceed, on behalf of 
the  European  Union,  to  transmitting  the  diplomatic  note  provided  for  in  Article  14  of  the 
Agreement on Mutual Recognition, in order to express the consent of the European Union to 
be bound by the Agreement.  

Article 3 

This  Decision  shall  enter  into  force  on  the  day  of  its  adoption.  It  shall  be  published  in  the 
Official Journal of the European Union. 

The date of entry into force of the Agreement shall be published in the Official Journal of the 
European Union.  

Done at Brussels, […] 

For the Council 
The President 
[…] 

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ANNEX I 

AGREEMENT 

amending the Agreement on Mutual Recognition in relation to Conformity Assessment, 
Certificates and Markings between the European Community and Australia 

THE EUROPEAN UNION AND AUSTRALIA, hereinafter referred to as ‘the Parties’, 

HAVING  concluded  an  Agreement  on  mutual  recognition  in  relation  to  conformity 
assessment,  certificates  and  markings  signed  in  Canberra  on  24  June  1998  (hereinafter 
referred to as ‘the Agreement’); 

NOTING the need to simplify the operation of the Agreement; 

NOTING the need to clarify the status of the Sectoral Annexes of the Agreement; 

WHEREAS Article 3 of the Agreement sets out the form of the Sectoral Annexes in detail; 

WHEREAS Article 4 of the Agreement restricts the application of the Agreement to industrial 
products that originate in the Parties according to non-preferential rules of origin; 

WHEREAS Article 12 of the Agreement establishes a Joint Committee that, inter alia, gives 
effect to decisions on the inclusion  of Conformity Assessment Bodies  in,  and their removal 
from, the Sectoral Annexes and sets out a procedure for such inclusion and removal; 

WHEREAS Articles 8 and 12 of the Agreement refer to the Chair of the Joint Committee; 

WHEREAS Article 12 of the Agreement does not explicitly empower the Joint Committee to 
amend the Sectoral Annexes, except to give effect to the decision by a Designating Authority 
to designate or to withdraw designation of a particular Conformity Assessment Body; 

CONSIDERING  that  Article  3  should  be  amended,  both  to  reflect  the  changes  proposed  to 
Article 12 to limit the requirement for the Joint Committee to take action on the recognition or 
withdrawal of recognition of conformity assessment bodies to cases that have been contested 
by the other Party under Article 8, and to allow greater flexibility in the structure of Sectoral 
Annexes to the Agreement; 

CONSIDERING that in order that trade between the Parties is not unnecessarily restricted, the 
origin restriction in Article 4 should be deleted; 

CONSIDERING that in order to reflect the fact that the Joint Committee is co-chaired by the 
Parties, the references to the Chair of the Joint Committee should be deleted from Articles 8 
and 12 of the Agreement; 

CONSIDERING  that  enhanced  exchange  of  information  between  the  Parties  regarding  the 
operation of the Agreement will facilitate its operation; 

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CONSIDERING that in order to make timely adaptations to the Sectoral Annexes in order to 
take  account  of  technical  progress,  and  other  factors  such  as  enlargement  of  the  European 
Union,  the  Joint  Committee  should  be  explicitly  empowered  in  Article  12  to  amend  the 
Sectoral Annexes in areas other than to give effect to the decision by a Designating Authority 
to designate or to withdraw designation of a particular Conformity Assessment Body, and also 
to adopt new Sectoral Annexes; 

RECOGNISING  that  the  Parties  may  need  to  undertake  certain  domestic  procedures  before 
amendments to Sectoral Annexes or the adoption of new Sectoral Annexes take effect; 

CONSIDERING  that  in  order  to  simplify  the  operation  of  the  Agreement,  the  need  for  the 
Joint Committee to take action on the recognition or withdrawal of recognition of Conformity 
Assessment  Bodies  should  be  limited  to  cases  that  have  been  contested  by  the  other  Party 
under Article 8; 

CONSIDERING that in order to simplify the operation of the Agreement, a simpler procedure 
for  the  recognition,  withdrawal  of  recognition,  and  suspension  of  Conformity  Assessment 
Bodies  should  be  set  up  in  Article  12,  and  the  position  regarding  conformity  assessment 
carried out by bodies afterwards suspended or withdrawn should be clarified, 

HAVE AGREED TO AMEND THE AGREEMENT AS FOLLOWS: 

Article 1 

Amendments to the Agreement 

The Agreement is amended as follows: 

1. 

Article 3(2) is replaced by the following: 

‘2.  Each Sectoral Annex shall, in general, contain the following information: 

(a) 

a statement of its scope and coverage; 

(b) 

the  legislative,  regulatory  and  administrative  requirements  pertaining  to 
the conformity assessment procedures; 

(c) 

the Designating Authorities; 

(d) 

a  set  of  procedures  for  the  designation  of  Conformity  Assessment 
Bodies; and 

(e) 

additional provisions as required.’ 

2. 

Article 4 is replaced by the following: 

‘Article 4 

Scope and coverage 

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The provisions of this Agreement shall apply to conformity assessment of products 
specified in the statement of scope and coverage in each Sectoral Annex.’ 

3. 

Article 6(1) is replaced by the following: 

‘1.  The  Parties  shall  ensure  that  the  Designating  Authorities  responsible  for 
designating  Conformity  Assessment  Bodies  have  the  necessary  power  and 
competence  to  designate,  suspend,  remove  suspension  of  and  withdraw  the 
designation of such bodies.’ 

4. 

Article 6(2) is replaced by the following: 

‘2. 

In  making  such  designations,  suspensions,  removals  of  suspension  and 
withdrawals,  Designating  Authorities  shall,  unless  specified  otherwise  in  the 
Sectoral Annexes, observe the procedures for designation set out in Article 12 
and the Annex.’ 

5. 

6. 

Article 6(3) is deleted. 

Article 7(1) is replaced by the following: 

‘1.  The  Parties  shall  exchange  information  concerning  the  procedures  used  to 
ensure  that  the  designated  Conformity  Assessment  Bodies  under  their 
responsibility  comply  with  the  legislative,  regulatory  and  administrative 
requirements  outlined 
the  competence 
requirements specified in the Annex.’ 

the  Sectoral  Annexes  and 

in 

7. 

Article 8(3) is replaced by the following: 

‘3.  Such contestation has to be justified in an objective and argued manner and in 

writing to the other Party and the Joint Committee’. 

8. 

Article 8(6) is replaced by the following: 

‘6.  Except  when  decided  otherwise  by  the  Joint  Committee,  the  contested 
the  competent 
Conformity  Assessment  Body  shall  be  suspended  by 
Designating  Authority  from  the  time  its  competence  or  compliance  was 
challenged until either agreement has been reached in the Joint Committee on 
the status of that body or the challenging Party notifies the other Party and the 
Joint Committee that it is satisfied as to the competence and compliance of the 
Conformity Assessment Body.’ 

9. 

Article 9 is replaced by the following: 

‘Article 9 

Exchange of information 

1. 

The  Parties  shall  exchange  information  concerning  the  implementation  of  the 
legislative,  regulatory  and  administrative  provisions  identified  in  the  Sectoral 
Annexes and shall maintain an accurate list of Conformity Assessment Bodies 
designated in accordance with this Agreement. 

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2. 

Consistent  with  their  obligations  under  the  World  Trade  Organisation 
Agreement  on  Technical  Barriers  to  Trade,  each  Party  shall  inform  the  other 
Party  of  the  changes  it  intends  to  make  to  the  legislative,  regulatory  and 
administrative provisions relating to the subject matter of this Agreement and 
shall,  except  as  provided  in  Article  9(3),  notify  the  other  Party  of  the  new 
provisions at least 60 days before their entry into force. 

3.  Where  a  Party  takes  urgent  measures  that  it  considers  warranted  by 
considerations of safety, health or protection of the environment to eliminate an 
immediate risk posed by a product covered by a Sectoral Annex, it shall notify 
the  other  Party  of  the  measures  and  the  reasons  for  the  imposition  of  the 
measures immediately, or as otherwise specified in a Sectoral Annex.’ 

10. 

Article 12(3) is replaced by the following: 

‘3.  The Joint Committee shall meet at least once a year unless the Joint Committee 
or the Parties otherwise decide. If required for the effective functioning of the 
Agreement, or at the request of either Party, an additional meeting or meetings 
shall be held.’ 

11. 

Article 12(4) is replaced by the following: 

‘4.  The Joint Committee may consider any matter related to the functioning of this 

Agreement. In particular, it shall be responsible for: 

(a) 

amending the Sectoral Annexes in accordance with this Agreement; 

(b) 

(c) 

(d) 

exchanging  information  concerning  the  procedures  used  by  either  Party 
to ensure that the Conformity Assessment Bodies maintain the necessary 
level of competence; 

in accordance with Article 8, appointing a joint team or teams of experts 
to  verify  the  technical  competence  of  a  Conformity  Assessment  Body 
and its compliance with other relevant requirements; 

exchanging  information  and  notifying  the  Parties  of  modifications  of 
legislative,  regulatory  and  administrative  provisions  referred  to  in  the 
Sectoral  Annexes,  including  those  which  require  modification  of  the 
Sectoral Annexes; 

(e) 

resolving any questions relating to the application of this Agreement and 
its Sectoral Annexes; 

(f) 

adopting new Sectoral Annexes in accordance with this Agreement.’ 

12. 

Article 12(5) is replaced by the following: 

‘5.  Any  amendments  to  Sectoral  Annexes  made  in  accordance  with  this 
Agreement  and  any  new  Sectoral  Annexes  adopted  in  accordance  with  this 
Agreement  shall  be  notified  promptly  in  writing  by  the  Joint  Committee  to 
each Party, and shall come into effect for both Parties on the date on which the 
Joint  Committee  has  received  notification  from  each  Party  confirming 

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completion of their respective procedures for the amendments or new Sectoral 
Annex  to  take  effect,  unless  otherwise  mutually  determined  in  writing  by  the 
Parties.’ 

13. 

Article 12(6) is replaced by the following: 

‘6.  The  following  procedure  shall  apply  in  relation  to  the  designation  of  a 

Conformity Assessment Body: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

a  Party  wishing  to  designate  any  Conformity  Assessment  Body  shall 
forward  its  proposal  to  the  other  Party  in  writing,  to  that  effect,  adding 
supporting  documentation  as  defined  by  the  Joint  Committee  to  the 
request; 

in the event that the other Party consents or upon the expiry of 60 days 
without  an  objection  having  been  lodged  in  accordance  with  the 
procedures  of  the  Joint  Committee,  the  Conformity  Assessment  Body 
shall  be  considered  to  be  a  designated  Conformity  Assessment  Body 
under the terms of Article 5; 

in  the  event  that,  under  Article  8,  the  other  Party  contests  the  technical 
competence or compliance of a Conformity Assessment Body within the 
aforementioned 60-day period, the Joint Committee may decide to carry 
out a verification of the body concerned, in accordance with Article 8; 

in  the  case  of  the  designation  of  a  new  Conformity  Assessment  Body, 
conformity  assessment  carried  out  by  such  a  Conformity  Assessment 
Body shall be valid from the date on which the Conformity Assessment 
Body becomes a designated Conformity Assessment Body in accordance 
with this Agreement; 

the 
either  Party  may  suspend,  remove  suspension  or  withdraw 
designation of a Conformity Assessment Body under its jurisdiction. The 
Party  concerned  shall  immediately  notify  the  other  Party  and  the  Joint 
Committee  of  its  decision  in  writing,  together  with  the  date  of  such 
decision. The suspension, removal of suspension or withdrawal shall take 
effect from the date of the Party’s decision; 

in  accordance  with  Article  8,  either  Party  may,  in  exceptional 
circumstances,  contest  the  technical  competence  of  a  designated 
Conformity Assessment Body under the jurisdiction of the other Party. In 
this  case  the  Joint  Committee  may  decide  to  carry  out  a  verification  of 
the body concerned, in accordance with Article 8.’ 

14. 

Article 12(7) is replaced by the following: 

‘7. 

In  the  event  that  the  designation  of  a  Conformity  Assessment  Body  is 
suspended or withdrawn, conformity assessment carried out by that Conformity 
Assessment  Body  before  the  date  of  effect  of  the  suspension  or  withdrawal 
shall remain valid unless either the responsible Party has limited or cancelled 
that  validity,  or  the  Joint  Committee  determines  otherwise.  The  Party  under 

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whose jurisdiction the suspended or withdrawn Conformity Assessment Body 
was  operating  shall  notify  the  other  Party  in  writing  of  any  such  changes 
relating to a limitation or cancellation of validity.’ 

15. 

After Article 12(8), the following is inserted into the Agreement as Article 12(9): 

‘9.  The  Joint  Committee  shall  maintain  current  Sectoral  Annexes  and  provide 

these to Parties upon amendments taking effect.’ 

16. 

Article 15(1) is replaced by the following: 

‘1.  The  Annex  to  this  Agreement  forms  an  integral  part  thereof.  The  Sectoral 
Annexes  form  the  administrative  arrangements  for  the  implementation  of  this 
Agreement and do not have treaty status.’ 

17. 

Article 15(3) is replaced by the following: 

‘3.  The  Joint  Committee  may  adopt  Sectoral  Annexes  to  which  Article  2  applies 
and  which  will  provide  the  implementing  arrangements  for  this  Agreement. 
Any  additional  Sectoral  Annexes  will  come  into  effect  in  accordance  with 
Article 12(5).’ 

18. 

Article 15(4) is replaced by the following: 

‘4.  Amendments  to  the  Sectoral  Annexes,  and  the  adoption  of  new  Sectoral 
Annexes, shall be determined by the Joint Committee and come into effect in 
accordance with Article 12(5).’ 

19. 

Paragraph 9 of the Annex is replaced by the following: 

‘9.  Designating Authorities shall inform their Party’s representatives on the Joint 
Committee,  established  under  Article  12  of  this  Agreement,  of  Conformity 
Assessment  Bodies  to  be  designated,  suspended  or  withdrawn.  Designation, 
suspension  or  withdrawal  of  designation  of  Conformity  Assessment  Bodies 
shall  take  place  in  accordance  with  the  provisions  of  this  Agreement  and  the 
rules of procedure of the Joint Committee.’ 

20. 

Paragraph 10 of the Annex is replaced by the following:  

‘10.  When advising their Party’s representative on the Joint Committee established 
under this Agreement, of the Conformity Assessment Bodies to be designated, 
the Designating Authority shall provide the following details in respect of each 
Conformity Assessment Body: 

(a) 

the name; 

(b) 

the postal address; 

(c) 

the facsimile (fax) number and email address; 

(d) 

the range of products, processes, standards or services it is authorised to 
assess; 

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(e) 

the conformity assessment procedures it is authorised to carry out; and 

(f) 

the designation procedure used to determine competence.’ 

21. 

The Sectoral Annex on medicinal products GMP inspections and batch certification 
is deleted and replaced by the following text: 

'SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND 
BATCH CERTIFICATION 

SCOPE AND COVERAGE 

1. 

The Parties mutually establish that the provisions of this Sectoral Annex will cover 
all  medicinal  products  which  are  industrially  manufactured  in  Australia  and  the 
European  Union,  and  to  which  Good  Manufacturing  Practice  (GMP)  requirements 
apply. 

For medicinal products covered by this Sectoral Annex, each Party will recognise the 
conclusions  of  inspections  of  manufacturers  carried  out  by  the  relevant  inspection 
services of the other Party and the relevant manufacturing authorisations granted by 
the competent authorities of the other Party. 

In  addition,  the  manufacturer’s  certification  of  the  conformity  of  each  batch  to  its 
specifications will be recognised by the other Party without re-control at import.  

“Medicinal products” means all products regulated by the pharmaceutical legislation 
in  the  European  Union  and  Australia  referred  to  in  Section  I.  The  definition  of 
medicinal products includes all human and veterinary products, such as chemical and 
biological  pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal 
products derived from human blood or human plasma, pre-mixes for the preparation 
of  veterinary  medicated  feedingstuffs,  and,  where  appropriate,  vitamins,  minerals, 
herbal remedies and homeopathic medicinal products. 

“GMP” is that part of quality assurance which ensures that products are consistently 
produced  and  controlled  during  manufacture  to  the  quality  standards  appropriate  to 
their  intended  use  and  as  required  by  the  marketing  authorisation  granted  by  the 
importing  Party.  For  the  purpose  of  this  Sectoral  Annex  it  includes  the  system 
whereby  the  manufacturer  receives  the  specification  of  the  product  and/or  process 
from the marketing authorisation holder or applicant and ensures that the medicinal 
product is made in compliance with this specification (equivalent to Qualified Person 
certification in the European Union). 

2. 

With  respect  to  medicinal  products  covered  by  the  legislation  of  one  Party 
(“regulating Party”) but not the other, the manufacturing company may request [the 
authority  nominated  by  the  relevant  contact  point  of  the  regulating  Party  listed  in 
Section III item 12], for the purpose of this Agreement, that an inspection be made 
by the locally competent inspection service. This provision will apply inter alia to the 
manufacture  of  active  pharmaceutical  ingredients  and  intermediate  products  and 
products  intended  for  use  in  clinical  trials,  as  well  as  mutually  determined  pre-
marketing inspections. Operational arrangements are detailed under Section III, item 
3 b. 

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Certification of manufacturers 

3. 

At the request of an exporter, importer or the competent authority of the other Party, 
the  authorities  responsible  for  granting  manufacturing  authorisations  and  for 
supervision  of  the  manufacture  of  medicinal  products  will  certify  that  the 
manufacturer: 

– 

– 

– 

 is appropriately authorised to manufacture the relevant medicinal product or to 
carry out the relevant specified manufacturing operation, 

 is regularly inspected by the authorities, and 

 complies with the national GMP requirements recognised as equivalent by the 
two parties, referred to in Section I. Where different GMP requirements may be 
used as a reference (in line with the provisions in Section III, item 3 b), this is 
to be mentioned in the certificate. 

The  certificates  will  also  identify  the  site(s)  of  manufacture  (and  contract  testing 
laboratories,  if  any).  The  format  of  the  certificate  will  be  decided  by  the  Joint 
Sectoral Group. 

Certificates  will  be  issued  expeditiously,  and  the  time  taken  should  not  exceed  30 
calendar days. In exceptional cases, such as when a new inspection has to be carried 
out, this period may be extended to 60 days. 

Batch certification 

4. 

Each  batch  exported  will  be  accompanied  by  a  batch  certificate  prepared  by  the 
manufacturer  (self  certification)  after  a  full  qualitative  analysis,  a  quantitative 
analysis  of  all  the  active  constituents  and  all  the  other  tests  or  checks  necessary  to 
ensure  the  quality  of  the  product  in  accordance  with  the  requirements  of  the 
marketing  authorisation.  This  certificate  will  attest  that  the  batch  meets  its 
specifications and will be kept by the importer of the batch. It will be made available 
upon request of the competent authority. 

in 

When  issuing  a  certificate,  the  manufacturer  will  take  account  of  the  provisions  of 
the  current  WHO  certification  scheme  on  the  quality  of  pharmaceutical  products 
moving 
the  agreed 
international  commerce.  The  certificate  will  detail 
specifications  of  the  product,  the  reference  of  the  analytical  methods  and  the 
analytical results. It will contain a statement that the batch processing and packaging 
records were reviewed and found in conformity with GMP. The batch certificate will 
be signed by the person responsible for releasing the batch for sale or supply, i.e. in 
the European Union the “qualified person” as referred to in relevant EU legislation. 
In  Australia,  the  responsible  persons  are  for  manufacturing  quality  control  as 
specified in the relevant Australian legislation. 

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SECTION I 

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS 

Subject to Section III “Operational provisions”, general GMP inspections will be carried out 
against  the  GMP  requirements  of  the  exporting  Party.  The  applicable  legislative,  regulatory 
and administrative provisions related to this Sectoral Annex are listed in the Appendix. 

However,  the  reference  quality  requirements  of  products  to  be  exported,  including  their 
manufacturing  method  and  product  specifications,  will  be  those  of  the  relevant  product 
marketing authorisation granted by the importing Party. 

SECTION II 

OFFICIAL INSPECTION SERVICES 

The  lists  of  official  inspection  services  related  to  this  Sectoral  Annex  have  been  mutually 
established by the Parties and will be maintained by them. If a Party requests the other Party 
for a copy of its latest lists of official inspection services, the requested Party will provide the 
requesting Party a copy of those lists within 30 days of the date of receipt of that request. 

SECTION III 

OPERATIONAL PROVISIONS 

1. 

Transmission of inspection reports 

Upon  reasoned  request,  the  relevant  inspection  services  will  forward  a  copy  of  the 
last  inspection  report  of  the  manufacturing  or  control  site,  in  case  analytical 
operations are contracted out. The request may concern a “full inspection report” or a 
“detailed  report”  (see  item  2  below).  Each  Party  will  deal  with  these  inspection 
reports with the degree of confidentiality requested by the Party of origin.  

If the manufacturing operations of the medicinal product in question have not been 
inspected recently, i.e. when the last inspection dates back to more than two years or 
a  particular  need  to  inspect  has  been  identified,  a  specific  and  detailed  inspection 
may  be  requested.  Parties  will  ensure  that  inspection  reports  are  forwarded  in  no 
more  than  30  calendar  days,  this  period  being  extended  to  60  days  should  a  new 
inspection be carried out.  

2. 

Inspection reports 

A  “full  inspection  report”  comprises  a  Site  Master  File  (compiled  by  the 
manufacturer  or  by  the  inspectorate)  and  a  narrative  report  by  the  inspectorate.  A 
“detailed report” responds to specific queries about a firm by the other Party. 

3. 

Reference GMP 

(a)  Manufacturers  will  be  inspected  against  the  applicable  GMP  of  the  exporting 

Party (see Section I). 

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(b)  With  respect  to  medicinal  products  covered  by  the  pharmaceutical  legislation 
of  the  importing  Party  but  not  the  exporting  one,  the  locally  competent 
inspection  service  willing  to  carry  out  an  inspection  of  the  relevant 
manufacturing operations will inspect against its own GMP or, in the absence 
of  specific  GMP  requirements,  against  the  applicable  GMP  of  the  importing 
Party.  This  will  also  be  the  case  when  the  locally  applicable  GMP  are  not 
considered equivalent, in terms of quality assurance of the finished product, to 
the GMP of the importing Party. 

 Equivalence of GMP requirements for specific products or classes of products 
(e.g. investigational medicinal products, starting materials) will be determined 
according to a procedure established by the Joint Sectoral Group. 

4. 

Nature of inspections 

(a) 

(b) 

Inspections  will  routinely  assess  the  compliance  of  the  manufacturer  with 
GMP.  These  are  called  general  GMP  inspections  (also  regular,  periodic,  or 
routine inspections).  

“Product-  or  process-oriented”  inspections  (which  may  be  “pre-marketing” 
inspections  as  relevant)  focus  on  the  manufacture  of  one  or  one  series  of 
product(s)  or  process(es)  and  include  an  assessment  of  the  validation  of  and 
compliance  with  specific  process  or  control  aspects  as  described  in  the 
marketing  authorisation.  Where  necessary,  relevant  product  information  (the 
quality  dossier  of  an  application/authorisation  dossier)  will  be  provided  in 
confidence to the inspectorate. 

5. 

Inspection/establishment fees 

The  regime  of  inspection/establishment  fees  is  determined  by  the  manufacturer’s 
location. Inspection/establishment fees will not be charged to manufacturers located 
on the territory of the other Party for products covered by this Sectoral Annex. 

6. 

Safeguard clause for inspections 

The  Parties  mutually  acknowledge  that  each  Party  reserves  the  right  to  conduct  its 
own inspection for reasons identified to the other  Party. Such inspections are to  be 
notified in advance to the other Party, which has the option of joining the inspection. 
Recourse to this safeguard clause should be an exception. Should such an inspection 
take place, inspection costs may be recovered. 

7. 

Exchange  of  information  between  authorities  and  approximation  of  quality 
requirements 

In  accordance  with  the  general  provisions  of  the  Agreement,  the  Parties  will 
exchange any relevant information necessary for the ongoing mutual recognition of 
inspections.  For  the  purposes  of  demonstration  of  capability  in  cases  of  significant 
changes to regulatory systems in either of the Parties, additional specific information 
may  be  requested  by  either  Party  in  relation  to  an  official  inspection  service.  Such 
specific  requests  may  cover  information on training, inspection procedures,  general 
information  and  document  exchange,  and  transparency  of  agency  audits  of  official 

EN 

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inspection  services  relevant  to  the  operation  of  this  Sectoral  Annex.  Such  requests 
should  be  made  through  and  managed  by  the  Joint  Sectoral  Group  as  part  of  an 
ongoing maintenance programme. 

In addition, the relevant authorities in Australia and in the EuropeanUnion will keep 
each  other  informed  of  any  new  technical  guidance  or  changes  to  inspection 
procedures. Each Party will consult the other before their adoption. 

8. 

Official batch release  

The  official  batch  release  procedure  is  an  additional  verification  of  safety  and 
efficacy  of  immunological  medicinal  products  (vaccines)  and  blood  derivatives, 
carried  out  by  the  competent  authorities  before  the  distribution  of  each  batch  of 
product. This Agreement will not encompass this mutual recognition of official batch 
releases. However, when an official batch release procedure applies the manufacturer 
will  provide,  at  the  request  of  the  importing  Party,  the  official  batch  release 
certificate  if  the  batch  in  question  has  been  tested  by  the  control  authorities  of  the 
exporting Party. 

For the European Union, the official batch release procedures for medicinal products 
for  human  use  are  published  by  the  European  Directorate  for  the  Quality  of 
Medicines  &  HealthCare.  For  Australia,  the  official  batch  release  procedure  is 
specified in document “WHO Technical Report Series, No 822, 1992”. 

9. 

Inspectors training 

In  accordance  with  the  general  provisions  of  the  Agreement,  training  sessions  for 
inspectors, organised by the authorities, will be accessible to inspectors of the other 
Party. The Parties to the Agreement will keep each other informed of these sessions. 

10. 

Joint inspections 

In  accordance  with  the  general  provisions  of  the  Agreement,  and  by  mutual 
arrangement  between  the  Parties,  joint  inspections  may  be  authorised.  These 
inspections  are  intended  to  develop  common  understanding  and  interpretation  of 
practice and requirements. The setting up of these inspections and their form will be 
established through procedures approved by the Joint Sectoral Group. 

11. 

Alert system 

Contact points will be agreed between the Parties to permit competent authorities and 
manufacturers to inform the authorities of the other Party with the appropriate speed 
in case of quality defects, batch recalls, counterfeiting and other problems concerning 
quality, which could necessitate additional controls or suspension of the distribution 
of the batch. A detailed alert procedure will be mutually established. 

The  Parties  will  ensure  that  any  suspension  or  withdrawal  (total  or  partial)  of  a 
manufacturing  authorisation,  based  on  non-compliance  with  GMP  and  which  could 
affect  the  protection  of  public  health,  are  communicated  to  each  other  with  the 
appropriate degree of urgency. 

12. 

Contact points 

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For the purpose of this Sectoral Annex, the contact points for any technical question, 
such  as  exchange  of  inspection  reports,  inspectors  training  sessions,  technical 
requirements, will be: 

For Australia: 
For medicinal products for human use: 
The Head of Office   
Therapeutic Goods Administration  
Department of Health and Ageing   
PO Box 100   
Woden ACT 2606 
Australia 
Tel: 61-6-232-8622   
Fax: 61-6-232-8426 

For medicinal products for use in animals:  
The Manager, GMP Section 
Australian Pesticides and Veterinary Medicines Authority 
PO Box 6182 
Kingston ACT 2604  
Australia 
Tel: 61-6210-4803   
Fax: 61-6210-4741 

For the European Union: 
The Director of the European Agency for the Evaluation of Medicinal Products  
7 Westferry Circus   
Canary Wharf 
London E14 4HB 
United Kingdom 
Tel: 44-171-418 8400 
Fax: 44-171-418 8416 

13. 

Joint Sectoral Group 

A Joint Sectoral Group made up of representatives of the Parties will be established 
under this Sectoral Annex. It will be responsible for the effective functioning of this 
Sectoral  Annex.  It  will  report  to  the  Joint  Committee  as  the  Joint  Committee  will 
determine.  

The  Joint  Sectoral  Group  will  determine  its own rules of procedure. It will take its 
decisions and adopt its recommendations by consensus. It may decide to delegate its 
tasks to subgroups. 

14. 

Divergence of views 

Both  Parties  will  use  their  best  endeavours  to  resolve  any  divergence  of  views 
concerning  inter  alia  compliance  of  manufacturers  and  conclusions  of  inspection 
reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.  

EN 

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SECTION IV 

CHANGES TO THE LIST OF OFFICIAL INSPECTION SERVICES 

The  Parties  mutually  recognise  the  need  for  this  Sectoral  Annex  to  accommodate  change, 
particularly  with  regard  to  the  entry  of  new  official  inspection  services  or  changes  in  the 
nature or role of established competent authorities. Where significant changes have occurred 
with regard to official inspection services, the Joint Sectoral Group will consider what, if any, 
additional  information  is  required  to  verify  programmes  and  establish  or  maintain  mutual 
recognition of inspections, in accordance with Section III, item 7. 

In  accordance  with  the  provisions  of  the  Agreement,  the  Australian  veterinary  medicinal 
product manufacturers will be inspected by the Therapeutic Goods Administration (TGA) on 
behalf  of  the  Australian  Pesticides  and  Veterinary  Medicines  Authority,  according  to  the 
current Australian code of GMP and the EC GMP Guide for veterinary medicinal products. 
The  European  Union  will  recognise  the  conclusions  of  inspections  carried  out  by  the  TGA 
and  Australian  manufacturers’  certifications  of  batch  conformity.  Should  the  Australian 
Pesticides  and  Veterinary  Medicines  Authority  (APVMA)  begin  to  carry  out  inspections 
itself, inspection reports will also be routinely transmitted to the importing Party until there 
has been a satisfactory verification of the APVMA GMP inspection programme. 

______________ 

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19 

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Appendix 1 

LIST OF APPLICABLE LEGISLATIVE, REGULATORY AND ADMINISTRATIVE 
PROVISIONS 

For the European Union: 

Council  Directive  65/65/EEC  of  26 January  1965  on  the  approximation  of  provisions  laid 
down by law, regulation or administrative action relating to proprietary medicinal products, as 
extended, widened and amended 

Second  Council  Directive  75/319/EEC  of  20 May  1975  on  the  approximation  of  provisions 
laid  down  by  law,  regulation  or  administrative  action  relating  to  proprietary  medicinal 
products, as extended, widened and amended 

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the 
Member States relating to veterinary medicinal products, as widened and amended 

Commission  Directive  91/356/EEC  of  13  June  1991  laying  down  the  principles  and 
guidelines of good manufacturing practice for medicinal products for human use 

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines 
of good manufacturing practice for veterinary medicinal products 

Council Regulation No (EEC) 2309/93 of 22 July 1993 laying down Community procedures 
for the authorisation and supervision of medicinal products for human and veterinary use and 
establishing a European Agency for the Evaluation of Medicinal Products 

Council  Directive  92/25/EEC  of  31 March  1992  on  the  wholesale  distribution  of  medicinal 
products for human use & Guide to Good Distribution Practice 

Current  version  of  the  Guide  to  Good  Manufacturing  Practice,  Rules  Governing  Medicinal 
Products in the European Community, Annex IV 

For Australia: 

For products for human use: 

Therapeutic  Goods  Act  1989,  and  Regulations,  Orders  and  Determinations  thereunder, 
including  Orders  setting  standards  such  as  labelling,  the  Determination  establishing 
Manufacturing Principles and Australian Codes of Good Manufacturing Practice 

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For products for veterinary use: 

Legislation — Commonwealth: 

Agricultural and Veterinary Chemicals (Administration) Act 1992  
Agricultural and Veterinary Chemicals Act 1994 
Agricultural and Veterinary Chemicals Code Act 1994 
Agricultural  and  Veterinary  Chemicals  (Administration)  Regulations  1995 
Agricultural  and  Veterinary  Chemicals  Instrument  No  1  (Manufacturing 

· 
· 
· 
· 
· 
Principles) 2007 
· 

Agricultural and Veterinary Chemicals Code Regulations 1995 

Legislation — New South Wales: 

· 
· 
· 
· 
· 
· 

Stock Foods Act 1940 
Stock Medicines Act 1989 
Public Health Act 1991 
Poisons and Therapeutic Goods Act 1966 
Pesticides Act 1979 
Agricultural and Veterinary Chemicals (NSW) Act 1994 

and including any regulations, orders or instruments made under this legislation 

Legislation — Victoria: 

· 
· 
· 
· 

Animal Preparations Act, 1987 
Health Act, 1958 
Drugs, Poisons and Controlled Substances Act, 1981 
Agricultural and Veterinary Chemicals (Victoria) Act 1994 

and including any regulations, orders or instruments made under this legislation 

Legislation — Queensland: 

· 
· 
· 
· 

Agricultural Standards Act 1994 
Stock Act 1915 
Health Act 1937 
Agricultural and Veterinary Chemicals (Queensland) Act 1994 

and including any regulations, orders or instruments made under this legislation 

Legislation — South Australia: 

· 
· 
· 
· 
· 
· 

Stock Medicines Act 1939-1978 
Stock Foods Act 1941 
Dangerous Substances Act 1986 
Controlled Substances Act 1984 
Stock Diseases Act 1934 
Agricultural and Veterinary Chemicals (SA) Act 1994 

and including any regulations, orders or instruments made under this legislation 

EN 

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Legislation — Western Australia: 

· 
· 
· 
· 
· 

Veterinary Preparations and Animal Feeding Stuffs Act 1976–1982 
Poisons Act 1964-1981 
Health Act 1911 
Agricultural and Veterinary Chemicals (WA) Act 1995 
Health (Pesticides) Regulations 1956 

and including any regulations, orders or instruments made under this legislation 

Legislation — Tasmania: 

· 
· 
· 
· 
· 

Veterinary Medicines Act 1987 
Poisons Act 1971 
Public Health Act 1997 
Agricultural and Veterinary Chemicals (Tasmania) Act 1994 
Pesticides Act 1968 

and including any regulations, orders or instruments made under this legislation 

Legislation — Northern Territory: 

· 
· 
· 
· 

Poisons and Dangerous Drugs Act 1983 
Therapeutic Goods and Cosmetics Act 1986  
Stock Diseases Act 1954 
Agricultural and Veterinary Chemicals (NT) Act 1994 

and including any regulations, orders or instruments made under this legislation 

Legislation — Australian Capital Territory 

· 

Environment Protection Act, 1997 

and including any regulations, orders or instruments made under this legislation.’ 

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22. 

The Sectoral Annex on medical devices is deleted and replaced by the following text: 

‘SECTORAL ANNEX ON 
MEDICAL DEVICES 

TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT 

ON MUTUAL RECOGNITION IN RELATION TO 
CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS 

SCOPE AND COVERAGE 

The  Parties  mutually  establish  that  the  provisions  of  this  Sectoral  Annex  will  apply  to  the 
following products: 

Products for export to the European Union 

(1) 

All medical devices: 

(a)  manufactured in Australia; and 

(b) 

(c) 

subject  to  third  party  conformity  assessment  procedures,  both  product-  and 
quality systems-related; and 

provided  for  in  Council  Directive  90/385/EEC  of  20  June  1990,  as  last 
amended,  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
active implantable medical devices; and  

(d)  provided for in Council Directive 93/42/EEC of 14 June 1993, as last amended, 

concerning medical devices.  

(2) 

For the purposes of paragraph (1):  

(a)  medical devices provided for in Appendix 1 are excluded; and 

(b)  unless  otherwise  provided  for  or  by  mutual  arrangement  by  the  Parties, 

“manufacture” of a medical device does not include: 

(i) 

restoration  or  renovation  processes  such  as  repairing,  re-conditioning, 
overhauling or refurbishing; or 

(ii)  operations  such  as  pressing, 

ticketing,  packaging  and 
preparation for sale, conducted alone or in combination with each other; 
or 

labelling, 

(iii)  quality control inspections alone; or 

(iv)  sterilisation alone. 

Products for export to Australia 

(1) 

All medical devices: 

(a)  manufactured in the European Union; and 

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(b) 

subject  to  conformity  assessment  procedures,  both  product-  and  quality 
systems-related,  under  the  Australian  Therapeutic  Goods  Act  1989  and 
Therapeutic Goods Regulations, as last amended.  

(2) 

For the purposes of paragraph (1):  

(a)  medical devices provided for in Appendix 1 are excluded; and 

(b)  unless  otherwise  provided  for  or  by  mutual  arrangement  by  the  Parties, 

“manufacture” of a medical device does not include: 

(i) 

restoration  or  renovation  processes  such  as  repairing,  re-conditioning, 
overhauling or refurbishing; or 

(ii)  operations  such  as  pressing, 

ticketing,  packaging  and 
preparation for sale, conducted alone or in combination with each other; 
or 

labelling, 

(iii)  quality control inspections alone; or 

(iv)  sterilisation alone. 

SECTION I 

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS 

Legislative, regulatory and administrative 
requirements of the European Union with which 
Australian-designated conformity assessment 
bodies will assess compliance 

regulatory 

Legislative, 
administrative 
requirements  of  Australia  with  which  European 
Union-designated  conformity  assessment  bodies 
will assess compliance 

and 

–  Council Directive 90/385/EEC of 20 June 1990 
on  the  approximation  of  the  laws  of  the 
Member  States  relating  to  active  implantable 
medical 
and 
supplemented 

amended 

devices, 

as 

–  Council Directive 93/42/EEC of 14 June 1993 
concerning  medical  devices,  as  amended  and 
supplemented 

–  and  any  legislation  adopted  on  the  basis  of 

these Directives. 

–  Therapeutic Goods Act 1989, as amended 

–  Therapeutic  Goods  Regulations  1990,  as 

amended 

–  Therapeutic Goods (Medical Devices) 

Regulations 2002, as amended 

–  and  any  subordinate  legislation  referred  to  in 
the above Acts or Regulations, as amended8 

8 

General  reference  to  Australia’s  subordinate  legislation  referred  to  in  the  Therapeutic  Goods  Act  and 
Regulations and to anticipate any legislative changes. 

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SECTION II 

DESIGNATED CONFORMITY ASSESSMENT BODIES 

Conformity  Assessment  Bodies  designated  by 
Australia to assess products against the European 
Union’s legislative, regulatory and administrative 
requirements 

Conformity Assessment Bodies designated by the 
to  assess  products  against 
European  Union 
and 
legislative, 
Australia’s 
administrative requirements 

regulatory 

The  lists  of  designated  Conformity  Assessment 
Bodies  have  been  mutually  established  by  the 
Parties and will be maintained by them. 

The  lists  of  designated  Conformity  Assessment 
Bodies  have  been  mutually  established  by  the 
Parties and will be maintained by them. 

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SECTION III 

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY 
ASSESSMENT BODIES FOR THE PURPOSES OF THIS AGREEMENT 

For  the  conformity  assessment  bodies  designated 
by Australia 

For the conformity assessment bodies designated 
by the Member States of the European Union 

—  Department  of  Health  and  Ageing  for  the 

— Belgium 

Therapeutic Goods Administration 

  Ministère 

de 

la 

l’environnement 
sociale/Ministerie 
Leefmilieu en Sociale Integratie 

de 

santé 

publique, 

de 
et 
l’intégration 
van  Volksgezondheid, 

— Denmark 

  Sundhedsministeriet 

— Germany 

  Zentralstelle der Länder für Gesundheitsschutz 
bei Arzneimitteln und Medizinprodukten  

— Greece 

  Ministry of Health 

— Spain 

  Ministerio de Sanidad y Consumo 

— France 

  Agence  française  de  sécurité  sanitaire  des 

produits de santé (AFSSAPS). 

— Ireland 

  Department of Health 

— Italy 

Istituto superiore di sanità 

— Luxembourg 

  Ministère de la santé 

— Netherlands 

  Staat der Nederlanden 

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— Austria 

  Bundesministerium für Arbeit, Gesundheit und 

Soziales 

— Portugal 

  Ministério da saúde 

— Finland 

  Sosiaali- 

ja 

terveysministeriö/Social-  och 

hälsovårdsministeriet 

— Sweden 

  Under  the  authority  of  the  Government  of 
för  ackreditering  och 

Sweden:  Styrelsen 
teknisk kontroll (SWEDAC) 

— United Kingdom 

  Medicines and Healthcare Products Regulatory 

Agency (MHRA) 

— Czech Republic 

  Czech  Office  for  Standards,  Metrology  and 

Testing 

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SECTION IV 

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES 

to  be  followed  by  Australia 

in 
Procedures 
designating  Conformity  Assessment  Bodies  to 
assess  products  against  the  European  Union’s 
requirements 

Procedures to be followed by the European Union 
in  designating  Conformity  Assessment  Bodies  to 
assess products against Australia’s requirements 

The  Therapeutic  Goods  Administration  of  the 
Department  of  Health  and  Ageing  will  meet  the 
requirements of the Directives listed in Section I, 
taking into account Council Decision 93/465/EEC 
of  22  July  1993  concerning  the  modules  for  the 
various  phases  of  the  conformity  assessment 
procedures  and  the  rules  for  the  affixing  and  use 
of the CE conformity marking, which are intended 
technical  harmonisation 
in 
to  be  used 
directives  and  be  designated 
specific 
for 
categories  or  classes  of  devices  and  conformity 
assessment  procedures.  For  products  covered  by 
Section V, designation will occur on the basis of a 
confidence-building  programme  as  mentioned  in 
paragraph 1.2 of Section V.9 

the 

Conformity  Assessment  Bodies  will  meet  the 
requirements mentioned in the Directives listed in 
Section  I,  taking  into  account  Council  Decision 
93/465/EEC  of  22  July  1993  concerning  the 
modules for the various phases of the conformity 
assessment  procedures  and  the  rules  for  the 
affixing  and  use  of  the  CE  conformity  marking, 
which  are  intended  to  be  used  in  the  technical 
harmonisation  directives  and  be  designated  for 
specific  categories  or  classes  of  devices  and 
conformity  assessment  procedures.  For  products 
covered  by  Section  V,  designation  will  occur  on 
the  basis  of  a  confidence-building  programme  as 
mentioned in paragraph 1.2 of Section V.10  

SECTION V 

ADDITIONAL PROVISIONS 

1. 

Confidence building with respect to high-risk devices 

1.1. 

A  confidence-building  process  for  the  purpose  of  strengthening  confidence  in  the 
designating  systems  of  each  of  the  Parties  will  apply  for  the  following  medical 
devices: 

– 

– 

– 

active implantable devices as defined in the legislation referred to in Section I; 

devices that are classified as class III devices under the legislation referred to 
in Section I; 

a medical device that is an implantable intra-ocular lens; 

9 

10 

Presumption  of  competence  is  following  successful  completion  of  confidence  building  for  Section  V 
devices. 
Presumption  of  competence  is  following  successful  completion  of  confidence  building  for  Section  V 
devices. 

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– 

– 

a medical device that is an intra-ocular visco-elastic fluid; 

a medical device that is a barrier indicated for contraception or prevention of 
the sexual transmission of disease. 

1.2. 

1.3 

The  Parties  will  establish  a  detailed  programme  to  this  effect  involving  the 
Therapeutic Goods Administration and the European Union’s competent authorities. 

The confidence-building period will be reviewed after two years commencing from 
the date the Sectoral Annex, as amended, becomes effective. 

1.4. 

Additional specific requirements for regulatory progress: 

1.4.1. 

In  pursuance  of  Articles  2,  7(1),  8(1)  and  9(1)  of  the  Agreement,  either  Party  may 
request  additional  specific  requirements  in  relation  to  the  Conformity  Assessment 
Bodies  for  the  purposes  of  demonstration  of  experience  in  the  evolving  regulatory 
systems. 

1.4.2.  These specific requirements may include training, observed Conformity Assessment 
Body audits, visits and information and document exchange, including audit reports. 

1.4.3.  These  requirements  may  likewise  be  applicable  in  relation  to  the  designation  of  a 

Conformity Assessment Body in accordance with this Agreement.  

2. 

2.1. 

Registration,  listing  and  inclusion  procedures  for  the  Australian  Register  of 
Therapeutic Goods (ARTG) 

The  Parties  recognise  that  Australian  procedures  under  the  Therapeutic  Goods  Act 
1989  for  the  registration,  listing  or  inclusion  of  products  for  market  surveillance 
purposes,  and  corresponding  European  Union  procedures,  are  unaffected  by  this 
Agreement. 

2.2.  Within  the  framework  of  this  Agreement,  the  Australian  Regulatory  Authority  will 
without delay enter a product from the European Union on the ARTG without further 
assessment  of  the  product.  This  is  contingent  upon  receipt  of  a  product  application 
accompanied  by  the  prescribed  fee  and  the  Conformity  Assessment  Body’s 
certification to Australia’s requirements.  

2.3. 

Any fees attached to registration by either Party will be related only to the costs of 
the medical device registration, enforcement  and post-market surveillance activities 
of the Parties in this sector. 

3. 

Exchange of information 

The Parties agree to inform each other of: 

– 

– 

– 

certificates withdrawn, suspended, restricted or revoked; 

adverse events in the context of the GHTF medical device vigilance procedure;  

matters concerning product safety; and 

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– 

any legislation or amendment to existing legislation adopted on the basis of the 
legal texts listed in Section I.  

The Parties will establish contact points for each of these purposes. 

The Parties will consider the consequences of the establishment of Eudamed. 

In  addition,  the  Therapeutic  Goods  Administration  will  advise  of  any  certificates 
issued. 

4. 

New legislation 

The Parties jointly note that Australia is to introduce  new legislation concerning in 
vitro diagnostics, and that any new arrangements will respect the principles on which 
the Agreement on Mutual Recognition is based.  

The Parties mutually declare their plan to extend the scope of the MRA to IVDs as 
soon as the Australian legislation on IVDs is in place. 

5. 

Measures to protect public health and safety 

Implementation  of  this  Sectoral  Annex  will  not  constrain  a  Party  from  taking 
measures  necessary  to  protect  public  health  and  safety,  in  accordance  with  the 
legislation  referred  to  in  Section  I.  Each  Party  will  duly  inform  the  other  Party  of 
such measures. 

6. 

Joint Sectoral Group 

A Joint Sectoral Group made up of representatives of the Parties will be established 
under this Sectoral Annex. It will be responsible for the effective functioning of this 
Sectoral  Annex.  It  will  report  to  the  Joint  Committee  as  the  Joint  Committee  will 
determine.  

The  Joint  Sectoral  Group  will  determine  its own rules of procedure. It will take its 
decisions and adopt its recommendations by consensus. It may decide to delegate its 
tasks to subgroups.  

7. 

Divergence of views 

Both  Parties  will  use  their  best  endeavours  to  resolve  any  divergence  of  views. 
Unresolved  divergences  of  view  will  be  referred  to  the  Joint  Sectoral  Group. 

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APPENDIX 1 

Pursuant to paragraph 2(a) of this Sectoral Annex, the provisions of this Sectoral Annex will 
not apply to the following devices: 

•  medical devices that contain or are manufactured using cells, tissues or tissue derivatives 
of  animal  origin  that  have  been  rendered  non-viable,  where  the  safety  with  regard  to 
viruses  or  other  transferable  agents  requires  validated  methods  for  elimination  or  viral 
inactivation in the course of the manufacturing process; 

•  medical  devices  that  contain  tissues,  cells  or  substances  of  microbial,  bacterial  or 

recombinant origin and are intended for use in or on the human body; 

•  medical devices incorporating tissues or tissue derivatives of human origin; 

•  medical devices incorporating stable derivatives of human blood or human plasma that are 

liable to act on the human body in a way that is ancillary to the device; 

•  medical devices that incorporate, or intend to incorporate, as an integral part, a substance 
that, if used separately, might be considered to be a medicine that is intended to act on a 
patient in a way that is ancillary to the device; 

•  a medical device that is intended by the manufacturer specifically to be used for chemical 
disinfection of another medical device, except for sterilisers using dry heat, moist heat or 
ethylene oxide.  

Both  Parties  may  decide  by  mutual  arrangement  to  extend  the  application  of  this  Sectoral 
Annex to the aforementioned medical devices.’  

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Article 2 

Entry into force 

This Agreement shall enter into force on the first day of the second month following the date 
on  which  the  Parties  have  exchanged  diplomatic  notes  confirming  the  completion  of  their 
respective procedures for entry into force of this Agreement. 

This Agreement is drawn up in two originals in the Bulgarian, Czech, Danish, Dutch, English, 
Estonian,  Finnish,  French,  German,  Greek,  Hungarian,  Irish,  Italian,  Latvian,  Lithuanian, 
Maltese,  Polish,  Portuguese,  Romanian,  Slovak,  Slovene,  Spanish  and  Swedish  languages, 
each text being equally authentic. 

On behalf of Australia 

On behalf of the European Union 

Signed in Canberra on 

Signed in Brussels on 

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