Proposal for a Council Decision on the conclusion of the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
Date: 2010-05-28
Institutions: European Commission
Subjects: Community certification, EC conformity marking, New Zealand, agreement (EU), mutual recognition principle, quality label, ratification of an agreement, revision of an agreement

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EUROPEAN COMMISSION 

Brussels, 28.5.2010 
COM(2010)258 final 

2010/0139 (NLE) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of the Agreement between the European Union and New Zealand 
amending the Agreement on mutual recognition in relation to conformity assessment 
between the European Community and New Zealand 

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EXPLANATORY MEMORANDUM 

I. 

1. 

THE AMENDMENT 

BACKGROUND 

The Agreement between the European Community and New Zealand (‘the Parties’) on mutual 
recognition  in  relation  to  conformity  assessment1  (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  Australia  on  mutual  recognition  in 
relation  to  conformity  assessment,  certificates  and  markings3  is  in  effect  identical  to  the 
Agreement  on  Mutual  Recognition  with  New  Zealand.  A  parallel  Agreement  amending  the 
Agreement with Australia 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. 

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

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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. 

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 New Zealand amending the Agreement on 
mutual  recognition  in  relation  to  conformity  assessment  between  the  European  Community 

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and New Zealand (hereinafter referred to as ‘the Agreement’) 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. 

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2010/0139 (NLE) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of an Agreement between the European Union and New Zealand 
amending the Agreement on mutual recognition in relation to conformity assessment 
between the European Community and New Zealand 

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  between 
the  European  Community  and  New  Zealand5  (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 New Zealand amending the Agreement on mutual recognition in 
relation  to  conformity  assessment  between  the  European  Community  and  New 
Zealand (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 New Zealand amending the Agreement on 
mutual  recognition  in  relation  to  conformity  assessment  between  the  European  Community 
and New Zealand (hereinafter referred to as ‘the Agreement’) is hereby concluded. 

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

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5 
6 
7 

OJ C […], […], p. […]. 
OJ L 229, 17.8.1998, p. 62. 
OJ L 5, 9.1.1999, p. 74. 
OJ L […], […], p. […]. 

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Article 2 

The President of the Council shall designate the person empowered to proceed, on behalf of 
the  European  Union,  to  transmiting  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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AGREEMENT 

amending the Agreement on Mutual Recognition in relation to Conformity Assessment 
between the European Community and New Zealand 

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

HAVING  concluded  an  Agreement  on  Mutual  Recognition  in  relation  to  Conformity 
Assessment, done at Wellington on 25 June 1998 (hereinafter referred to as ‘the Agreement’); 

NOTING the need to simplify the operation of the Agreement; 

WHEREAS Article 3 of the Agreement sets out the form of the Sectoral Annexes in detail, 
and,  specifically,  provides  that  Section  II  of  each  Sectoral  Annex  to  the  Agreement  shall 
contain a list of the designated Conformity Assessment Bodies; 

WHEREAS Article 4 of the Agreement restricts the application of the Agreement to 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; 

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; 

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CONSIDERING  that  in  order  to  simplify  the  operation  of  the  Agreement,  the  need  for  the 
Joint  Committee  to  take  decisions  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 before their designation is suspended or withdrawn should be clarified; 

CONSIDERING  that  the  Agreement  on  mutual  recognition  in  relation  to  conformity 
assessment, certificates and markings between the European Union and Australia is identical 
in  form  to  the  Agreement,  and  is  therefore  being  amended  in  parallel  in  order  to  retain 
coherence between the Agreements; 

CONSIDERING that the legal references and mode of operation of the Sectoral Annexes on 
Medicinal  Products  GMP  Inspections  and  Batch  Certification  and  on  Medical  Devices  are 
outdated, and the opportunity has been taken to amend them to reflect the current position; 

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 

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

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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  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 
Conformity  Assessment  Body  shall  be  suspended  by 
the  competent 
Designating Authority from the time its technical competence and compliance 
is  contested  in  accordance  with  this  Article  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  technical  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  Organization 
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  of  this  Agreement,  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  manage  a 
risk  posed  by  a  product  covered  by  a  Sectoral  Annex,  it  shall  notify 
immediately  the  other  Party  of  the  measures,  with  a  brief  indication  of  the 
objective  and  the  rationale  of  the  measures,  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 decide otherwise. If required for the effective functioning of this 
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; and 

(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 

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Agreement  shall  be  notified  promptly  in  writing  by  the  Joint  Committee  to 
each Party, and shall come into effect as determined by the Joint Committee.’  

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 may be 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  any 
applicable  procedures  established  by  the  Joint  Committee,  to  the 
proposal,  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 that Article; 

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;  

either  Party  may  suspend,  remove  the  suspension  of,  or  withdraw  the 
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  of  the 
designation 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 
whose jurisdiction the suspended or withdrawn Conformity Assessment Body 

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was  operating  shall  notify  the  other  Party  in  writing  of  any  such  changes 
relating to a limitation or cancellation of validity.’  

15. 

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.’ 

16. 

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.’ 

17. 

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.  The 
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.’ 

18. 

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 electronic mail (email) address;  

(d) 

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

(e) 

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

(f) 

the designation procedure used to determine competence.’ 

_____________ 

Article 2 

Amendments to Sectoral Annexes 

1. 

The  Sectoral  Annex  on  Medicinal  Products  GMP  Inspections  and  Batch 
Certification, including Appendix 1 and Appendix 2, is deleted and replaced by the 
following:  

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‘SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND 
BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY – NEW ZEALAND 
AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY 
ASSESSMENT, CERTIFICATES AND MARKINGS 

SCOPE AND COVERAGE 

1. 

The  provisions  of  this  Sectoral  Annex  cover  all  medicinal  products  which  are 
industrially  manufactured  in  New  Zealand  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 New Zealand 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 homoeopathic 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 
paragraph 12 of Section III, 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  jointly  determined  pre-
marketing inspections. Operational arrangements are detailed under Section III, item 
3 b. 

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 

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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  are 
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 
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  to  be  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 
European Union legislation. In New Zealand, the responsible person is named on the 
licence to manufacture issued under the relevant New Zealand legislation. 

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 set out in Table I below.  

EN 

14 

   EN 

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. 

Table I: 

Applicable legislative, regulatory and 
administrative provisions for the 
European Union  

Applicable legislative, regulatory and 
administrative provisions for New 
Zealand  

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

relating 

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

relating 
products, 

•  Medicines Act 1981 

•  Medicines Regulations 1984 

•  New 

Code 

Zealand 

of  Good 
Manufacturing  Practice  for  Manufacture 
and  Distribution  of  Therapeutic  Goods, 
Parts 1, 2, 4 and 5 

•  Agricultural  Compounds  and  Veterinary 

Medicines Act 1997 

•  Animal Remedies Regulations 1980 

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

products, 

•  Code  of  Good  Manufacturing  Practice 

for Animal Remedies 1984  

•  and  any  legislation  adopted  on  the  basis 
of or that amends the above legislation.  

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

for  medicinal  products 

of 

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

of 
for 

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

veterinary 

and 

use 

EN 

15 

   EN 

 
 
 
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 

(94/C 63/03) 

•  Current  version  of  the  Guide  to  Good 
Manufacturing Practice, Rules Governing 
the  European 
Medicinal  Products 
Union, Annex IV. 

in 

SECTION II:  

OFFICIAL INSPECTION SERVICES 

The lists of official inspection services related to this Annex have been jointly determined 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 
with a copy of those lists within 30 days of the date of receipt of the 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  the  case  where 
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 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 

EN 

16 

   EN 

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

Party (see Section I ). 

(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 

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  this  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 

EN 

17 

   EN 

 
 
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 
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 New Zealand and in the European Union 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  does  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 procedure for medicinal products 
for human use is published by the European Directorate for the Quality of Medicines 
& HealthCare. For New Zealand, 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  this  Agreement,  training  sessions  for 
inspectors, organised by the authorities, will be accessible to inspectors of the other 
Party. The Parties to this Agreement will keep each other informed of these sessions. 

10. 

Joint inspections 

In  accordance  with  the  general  provisions  of  this  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 designated by 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 jointly 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 

EN 

18 

   EN 

affect  the  protection  of  public  health,  are  communicated  to  each  other  with  the 
appropriate degree of urgency. 

12. 

Contact points 

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

FOR NEW ZEALAND: 
For medicinal products for human use: 
Group Manager 
Medicines and Medical Devices Safety Authority (Medsafe) 
PO Box 5013 
Wellington 
New Zealand 
Tel: 64-4-819 6874   
Fax: 64-4-819 6806 

For medicinal products for use in animals:  
The Director  
New Zealand Food Safety Authority 
Agricultural Compounds and Veterinary Medicines Group 
PO Box 2835 
Wellington 
New Zealand 
Tel: 64-4-894 2562   
Fax: 64-4-894 2566 

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 

EN 

19 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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.  

SECTION IV:  

CHANGES TO THE LIST OF OFFICIAL INSPECTION SERVICES 

The Parties 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.’ 

______________ 

1. 

The Sectoral Annex on Medical Devices is deleted and replaced by the following: 

‘SECTORAL ANNEX  ON MEDICAL DEVICES TO THE EUROPEAN 
COMMUNITY – NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN 
RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS 

SCOPE AND COVERAGE 

The provisions of this Sectoral Annex will apply to the following products: 

Products for export to the European 
Union 

Products for export to New Zealand 

(1) All medical devices: 

(1) 

All medical devices: 

(a) 

(b) 

manufactured 
Union; and 

in 

the  European 

subject  to  third  party  conformity 
assessment  procedures,  both  product 
systems-related,  or 
and  quality 
subject  to  other  requirements  under 
the  legislation  listed  in  Section  I  of 
this Sectoral Annex, as last amended. 

(a) manufactured in New Zealand; and 

(b) 

(c) 

(d) 

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  Member  States 
the 
relating 
implantable 
active 
medical devices; and 

laws  of 
to 

provided  for  in  Council  Directive 
93/42/EEC  of  14  June  1993,  as  last 
amended, 
concerning  medical 
devices. 

EN 

20 

   EN 

 
(2) For the purposes of paragraph (1): 

(2) 

For the purposes of paragraph (1): 

(a) 

(b) 

medical  devices  provided  for 
Appendix 1 are excluded; and 

in 

(a) 

medical  devices  provided  for 
Appendix 1 are excluded; and 

in 

unless  otherwise  provided  for  or  by 
mutual  arrangement  by  the  Parties, 
“manufacture”  of  a  medical  device 
does not include: 

(b) 

unless  otherwise  provided  for  or  by 
mutual  arrangement  by  the  Parties, 
“manufacture”  of  a  medical  device 
does not include: 

(i) 

(ii) 

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

operations such as pressing, 
labelling, ticketing, 
packaging and preparation 
for sale, conducted alone or 
in combination with each 
other; or 

(i) 

(ii) 

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

operations such as pressing, 
labelling, ticketing, 
packaging and preparation 
for sale, conducted alone or 
in combination with each 
other; or 

(iii) 

quality control inspections 
alone; or 

(iii) 

quality  control 
alone; or 

inspections 

(iv) 

sterilisation alone. 

(iv) 

sterilisation alone. 

SECTION I : LEGISLATIVE, REGULATORY AND ADMINISTRATIVE 
REQUIREMENTS 

The legislative, regulatory and 
administrative requirements of the 
European Union with which New 
Zealand-designated Conformity 
Assessment Bodies will assess compliance 

The legislative, regulatory and 
administrative requirements of New 
Zealand with which European Union-
designated Conformity Assessment 
Bodies will assess compliance 

EN 

21 

   EN 

 
 
•  Council Directive of 20 June 1990 on the 
the 
active 
devices 

the 
approximation  of 
relating 
Member  States 
medical 
implantable 
(90/385/EEC), as amended 

laws  of 
to 

•  Radiocommunications  Act  1989  and 
Regulations made pursuant to that Act 

•  Electricity  Act  1992  and  Regulations 

made pursuant to that Act 

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

•  Medicines Act 1981 

•  Medicines Regulations 1984 

•  and  any  EC  legislation  adopted  on  the 

basis of these Directives. 

•  Medicines 

(Database 

of  Medical 

Devices) Regulations 2003 

•  and  any  legislation  adopted  on  the  basis 
of or that amends the above legislation.  

SECTION II : THE AUTHORITIES RESPONSIBLE FOR DESIGNATING 
CONFORMITY ASSESSMENT BODIES UNDER THIS SECTORAL ANNEX 

For the Conformity Assessment Bodies 
designated by New Zealand 

For the Conformity Assessment Bodies 
designated by the European Union 

(cid:121) 

Ministry of Health 

•  Belgium 
  Ministère  de 

l'Environnement 
sociale 
  Ministerie 

van 

la  Santé  publique,  de 
l'Intégration 

et  de 

Volksgezondheid, 

Leefmilieu en Sociale Integrati 

•  Denmark 

Sundhedsministeriet 

•  Germany 
  Bundesministerium für Gesundheit 

•  Greece 
  Ministry of Health 

•  Spain 
  Ministerio Sanidad y Consumo 

•  France 
  Ministère de la Santé 

EN 

22 

   EN 

 
 
 
 
 
 
 
 
 
 
•  Ireland 
  Department of Health 

•  Italy 
  Ministero Sanità 

•  Luxembourg 
  Ministère de la Santé 

•  Netherlands 
  Ministerie 

van 

Volksgezondheid, 

Welzijn en Sport 

•  Austria 
  Bundesministerium  für  wirtschaftliche 

Angelegenheiten 

•  Portugal 
  Ministério da Saúde 

•  Finland 
  Sosiaali- ja terveysministeriö 

•  Sweden 
  Under  the  authority  of  the  Government 

of Sweden: 

  Styrelsen  för  ackreditering  och  teknisk 

controll (SWEDAC) 

•  United Kingdom 
  Department of Health 

SECTION III : PROCEDURES FOR DESIGNATING CONFORMITY 
ASSESSMENT BODIES 

The procedures to be followed by New 
Zealand in designating Conformity 
Assessment Bodies to assess products 
against the European Union's 
requirements 

The procedures to be followed by the 
European Union in designating Conformity 
Assessment Bodies to assess products 
against New Zealand's requirements 

EN 

23 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conformity  Assessment  Bodies 
to  be 
designated  for  the  purposes  of  this  Sectoral 
Annex  will  meet  the  requirements  of  the 
Directives  listed  in  Section  I,  taking  into 
account  Council  Decision  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 
(93/465/EEC), and be designated on the basis 
of the procedures defined in the Annex to the 
Agreement.  This  may  be  demonstrated 
through: 

(a)  Product  Certification  Bodies  operating 
according 
requirements  of 
the 
EN 45011  or  ISO  Guide  28  and  40,  and 
either: 

to 

• 

• 

accredited  by  the  Joint  Accreditation 
System  of  Australia  and  New  Zealand 
(JAS-ANZ), or 

able to demonstrate competence by other 
means in accordance with Sections A and 
B of the Annex to the Agreement. 

(b)  Quality  System  Certification  Bodies 
operating  according  to  the  requirements 
of EN 45012 or ISO Guide 62, and either: 

• 

• 

accredited by JAS-ANZ, or 

able to demonstrate competence by other 
means in accordance with Sections A and 
B of the Annex to the Agreement. 

(c)  Inspection Bodies operating according to 
the  requirements  of  ISO/IEC  17020,  and 
either: 

(cid:121) 

accredited  by  the  Testing  Laboratory 
Registration  Council  of  New  Zealand 
or  any  other  body  established  by  law 
in New Zealand which replaces it and 
which has the same functions, or 

1. 

2. 

for 

procedures 

The 
designating 
Conformity  Assessment  Bodies  will 
be  consistent  with  the  principles  and 
procedures set out in the Annex to the 
Agreement. 

The  following  procedures  are  deemed 
to  be  consistent  with  those  set  out  in 
the Annex to the Agreement: 

(a) 

Certification Bodies: 

(cid:121) 

• 

• 

(cid:121) 

accredited  by  accreditation  bodies 
which  are  signatories  to  the  European 
cooperation  for  Accreditation  (EA) 
Multilateral  Agreement  (MLA)  for 
certification of products, 

members of the IECEE CB Scheme, 

accredited  by  an  accreditation  body 
with  which  JAS-ANZ  has  a  mutual 
recognition agreement, or 

able  to  demonstrate  competence  by 
other  means 
in  accordance  with 
Section  A  and  B  of  the  Annex  to  the 
Agreement. 

(b) 

Testing Laboratories: 

(cid:121) 

(cid:121) 

(cid:121) 

accredited  by  accreditation  bodies 
which  are  signatories  to  the  European 
cooperation  for  Accreditation  (EA) 
Multilateral  Agreement  (MLA)  for 
calibration and testing laboratories, 

recognised  within 
Scheme, or 

the  IECEE  CB 

able  to  demonstrate  competence  by 
in  accordance  with 
other  means 
Section  A  and  B  of  the  Annex  to  the 
Agreement. 

Pursuant  to  paragraph  5.2  in  Section  IV  of 
this  Sectoral  Annex,  designation  for  high-
risk devices  listed  in  paragraph  5.1  in  the 
same  Section  will  occur  on  the  basis  of  a 
confidence-building programme. 

EN 

24 

   EN 

 
(cid:121) 

able  to  demonstrate  competence  by 
other  means 
in  accordance  with 
Sections A and B of the Annex to the 
Agreement. 

Pursuant  to  paragraph  5.2  in  Section  IV  of 
this  Sectoral  Annex,  designation  for  high-
risk devices  listed  in  paragraph  5.1  in  the 
same  Section  will  occur  on  the  basis  of  a 
confidence-building programme. 

SECTION IV : ADDITIONAL PROVISIONS 

1. 

New legislation 

The  Parties  note  New  Zealand's  intention  to  introduce  new  legislation  concerning 
medical  devices,  and  jointly  decide  that  the  provisions  of  this  Sectoral  Annex  will 
apply to this legislation upon its entry into force in New Zealand. 

The Parties jointly declare their intention to extend the scope of this Sectoral Annex 
to in vitro diagnostic devices as soon as New Zealand’s new legislation concerning 
medical devices is in place. 

2. 

Exchange of information 

The Parties will inform each other of incidents in the context of the medical device 
vigilance procedure, or with regard to matters concerning product safety. The Parties 
will also inform each other of: 

(a) 

certificates withdrawn, suspended, restricted or revoked; and 

(b) 

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

The contact points through which the information can be passed are: 

(a) 

New Zealand: 

The Manager 
Medicines and Medical Devices Safety 
Authority (Medsafe) 
PO Box 5013 
Wellington 
New Zealand 
Tel.: 64-4-819 6874 
Fax: 64-4-819 6806 

and 

Group Manager 

25 

   EN 

EN 

 
 
 
 
 
 
(b) 

European Union 

Energy Safety and Radio Spectrum 
Management 
Ministry of Economic Development (MED) 
P.O. Box 1473 
Wellington 
New Zealand 
Tel.: 64-4-472-0030 
Fax: 64-4-471-0500 

European Commission 
Directorate-General for Health and 
Consumers 
Rue de la Loi 200 
B-1049 Brussels 
Tel.: 32-2-299.11.11 

The Parties may exchange information on the consequences of the establishment of 
Eudamed. 

In addition, the Medicines and Medical Devices Safety Authority will advise of any 
certificates issued. 

3. 

Subcontracting 

Where  required  by  New  Zealand 
legislative,  regulatory  and  administrative 
provisions,  European  Union  Conformity  Assessment  Bodies  subcontracting  all  or 
part  of  the  testing  will  subcontract  only  to  testing  laboratories  accredited  in 
accordance with Section III, item 2 of this Sectoral Annex. 

4. 

Recording of approvals granted 

In  addition  to  the  requirements  imposed  by  the  Annex  to  the  Agreement,  on 
designation  of  a  Conformity  Assessment  Body,  the  relevant  European  Union 
Designating  Authority  will  provide  to  New  Zealand,  in  respect  of  each  designated 
Conformity  Assessment  Body,  details  of  the  method  that  that  Conformity 
Assessment Body intends to adopt to record the fact that an approval required by the 
Secretary under the Electricity Act 1992 (and Regulations made pursuant to that Act) 
for  fittings  or  appliances  to  be  sold  or  offered  for  sale  in  New  Zealand  has  been 
granted. 

5. 

5.1 

Confidence-building with respect to high-risk devices 

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; 

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– 

– 

– 

medical devices that are an implantable intra-ocular lens; 

medical devices that are an intra-ocular visco elastic fluid; and 

medical devices that are a barrier indicated for contraception or prevention of 
the sexual transmission of disease. 

5.2 

5.3 

The  Parties  will  establish  a  detailed  programme  to  this  effect  involving  the 
Medicines  and  Medical  Devices  Safety  Authority  and  the  European  Union’s 
competent authorities. 

The  confidence-building  period  will  be  reviewed  after  two  (2)  years  commencing 
from the date the Sectoral Annex, as amended, becomes effective.  

5.4 

Additional specific requirements for regulatory progress: 

5.4.1 

In pursuance of Articles 2, 7(1), 8(1) and 9(1) of this 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. 

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

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

Conformity Assessment Body in accordance with this Agreement. 

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 
concerning  inter  alia  compliance  of  manufacturers  and  conclusions  of  conformity 
assessment  reports.  Unresolved  divergences  of  view  will  be  referred  to  the  Joint 
Sectoral Group. 

APPENDIX 1 

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 

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– 

– 

– 

– 

– 

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; and 

medical  devices  that  are  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  common  arrangement  to  extend  the  application  of  this  Sectoral 
Annex to the aforementioned medical devices.’ 

_____________ 

Article 3 

Entry into force 

1. 
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. 

2. 
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 New Zealand 

On behalf of the European Union 

DONE in ____________ on _____________  DONE in ____________ on _____________ 

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