HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 356/2
EN
Official Journal of the European Union
22.12.2012
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 EUROPEAN UNION
and
NEW ZEALAND,
hereinafter ‘the Parties’,
HAVING concluded the Agreement on mutual recognition in relation to conformity assessment ( 1 ), done at Wellington
on 25 June 1998 (hereinafter ‘the Agreement on Mutual Recognition’);
NOTING the need to simplify the operation of the Agreement on Mutual Recognition;
WHEREAS Article 3 of the Agreement on Mutual Recognition 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 on Mutual Recognition 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 on Mutual Recognition 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 on Mutual Recognition refer to the Chair of the Joint Committee;
WHEREAS Article 12 of the Agreement on Mutual Recognition 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 of the Agreement on Mutual Recognition should be amended, both to reflect the changes
proposed to Article 12 thereof 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 of the Agreement on Mutual Recognition, 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 of the Agreement on Mutual Recognition 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 on Mutual Recognition;
CONSIDERING that enhanced exchange of information between the Parties regarding the operation of the Agreement on
Mutual Recognition will facilitate its operation;
CONSIDERING that in order to make timely adaptations to the Sectoral Annexes so as 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 of the Agreement on Mutual Recognition 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;
( 1 ) OJ L 229, 17.8.1998, p. 62.

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CONSIDERING that in order to simplify the operation of the Agreement on Mutual Recognition, 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 of the Agreement on Mutual Recognition;
CONSIDERING that in order to simplify the operation of the Agreement on Mutual Recognition, a simpler procedure for
the recognition, withdrawal of recognition, and suspension of conformity assessment bodies should be set up in Article 12
thereof, 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 Community and Australia is identical in form to the Agreement on Mutual Recognition, 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
inspection 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 AS FOLLOWS:
bodies have the necessary power and competence to
designate, suspend, remove suspension and withdraw the
designation of such bodies.
Article 1
Amendments to the Agreement on Mutual Recognition
2. In
making
such
designations,
suspensions,
removals
The Agreement on Mutual Recognition is hereby amended as
of suspension and withdrawals, designating authorities
follows:
shall, unless specified otherwise in the Sectoral Annexes,
observe the procedures for designation set out in Article 12
and the Annex.’.
1. Article 3(2) is replaced by the following:
‘2. Each
Sectoral
Annex
shall,
in
general,
contain
the
4. Article 7(1) is replaced by the following:
following information:
‘1. The
Parties
shall
exchange
information
concerning
(a) a statement of its scope and coverage;
the procedures used to ensure that the designated
conformity assessment bodies under their responsibility
comply with the legislative, regulatory and administrative
(b) the legislative, regulatory and administrative
requirements outlined in the Sectoral Annexes and the
requirements pertaining to the conformity assessment
competence requirements specified in the Annex.’.
procedures;
(c) the designating authorities;
5. Article 8 is amended as follows:
(d) a set of procedures for the designation of conformity
(a) paragraph 3 is replaced by the following:
assessment bodies, and
‘3. Such
contestation
has
to
be
justified
in
an
(e) additional provisions as required.’.
objective and argued manner and in writing to the
other Party and to the Joint Committee.’;
2. Article 4 is replaced by the following:
(b) paragraph 6 is replaced by the following:
‘Article 4
Scope and coverage
‘6. Except
when
decided
otherwise
by
the
Joint
This Agreement shall apply to products specified in the
Committee, the contested conformity assessment body
statement of scope and coverage in each Sectoral Annex.’.
shall be suspended by the competent designating
authority from the time its technical competence and
compliance is contested in accordance with this Article
3. Article 6 is replaced by the following:
until either agreement is reached in the Joint
Committee on the status of that body or the chall
enging Party notifies the other Party and the Joint
‘Article 6
Committee that it is satisfied as to the technical
Designating authorities
competence and compliance of that body.’.
1. The
Parties
shall
ensure
that
the
designating
auth
orities responsible for designating conformity assessment
6. Article 9 is replaced by the following:

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‘Article 9
(e) resolving any questions relating to the application of
this Agreement and its Sectoral Annexes, and
Exchange of information
1. The
Parties
shall
exchange
information
concerning
the
implementation of the legislative, regulatory and adminis
(f) adopting new Sectoral Annexes in accordance with this
trative provisions identified in the Sectoral Annexes and
Agreement.
shall maintain an accurate list of conformity assessment
bodies designated in accordance with this Agreement.
5. Any
amendments
to
the
Sectoral
Annexes
made
in
accordance with this Agreement and any new Sectoral
2. Consistent
with
their
obligations
under
the
World
Annexes adopted in accordance with this Agreement shall
Trade Organization Agreement on Technical Barriers to
be notified promptly in writing by the Joint Committee to
Trade, each Party shall inform the other Party of the
each Party, and shall come into effect as determined by the
changes it intends to make to the legislative, regulatory
Joint Committee.
and administrative provisions relating to the subject
matter of this Agreement and shall, except as provided
for in paragraph 3 of this Article, notify the other Party
6. The
following
procedure
shall
apply
in
relation
to
the
of the new provisions at least 60 calendar days before their
designation of a conformity assessment body:
entry into force.
(a) a Party wishing to designate a conformity assessment
3. Where
a
Party
takes
urgent
measures
that
it
considers
body shall forward its proposal to that effect to the
warranted by considerations of safety, health or protection
other Party in writing, adding supporting documen
of the environment in order to manage a risk posed by a
tation, as may be defined by the Joint Committee;
product covered by a Sectoral Annex, it shall notify
immediately the other Party of the measures, with a brief
indication of their objective and rationale, or as otherwise
(b) in the event that the other Party consents to the
specified in the Sectoral Annex.’.
proposal or upon the expiry of 60 calendar days
without an objection having been lodged, in accordance
with any applicable procedures established by the Joint
7. Paragraphs 3 to 7 of Article 12 are replaced by the
Committee, the conformity assessment body shall be
following:
considered to be a designated conformity assessment
body under the terms of Article 5;
‘3. The
Joint
Committee
shall
meet
at
least
once
a
year
unless the Joint Committee or the Parties decide otherwise.
(c) in the event that, under Article 8, the other Party
If required for the effective functioning of this Agreement,
contests the technical competence or compliance of
or at the request of either Party, an additional meeting or
the proposed conformity assessment body within the
meetings shall be held.
aforementioned 60-day period, the Joint Committee
may decide to carry out a verification of the body
concerned, in accordance with Article 8;
4. The
Joint
Committee
may
consider
any
matter
related
to the functioning of this Agreement. In particular, it shall
be responsible for:
(d) in the case of the designation of a new conformity
assessment body, conformity assessment carried out
by such a body shall be valid from the date on
(a) amending the Sectoral Annexes in accordance with this
which it becomes a designated conformity assessment
Agreement;
body in accordance with this Agreement;
(b) exchanging information concerning the procedures
(e) either Party may suspend, remove the suspension of, or
used by either Party to ensure that the conformity
withdraw the designation of a conformity assessment
assessment bodies maintain the necessary level of
body under its jurisdiction. The Party concerned shall
competence;
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
(c) in accordance with Article 8, appointing a joint team or
suspension or withdrawal of the designation shall take
teams of experts to verify the technical competence of a
effect from the date of the Party’s decision;
conformity assessment body and its compliance with
other relevant requirements;
(f) in accordance with Article 8, either Party may, in
exceptional circumstances, contest the technical
(d) exchanging information and notifying the Parties of
competence of a designated conformity assessment
modifications of legislative, regulatory and adminis
body under the jurisdiction of the other Party. In this
trative provisions referred to in the Sectoral Annexes
case the Joint Committee may decide to carry out a
including those which require modification of the
verification of the body concerned, in accordance
Sectoral Annexes;
with Article 8.

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7. In
the
event
that
the
designation
of
a
conformity
‘9. Designating
authorities
shall
inform
their
Party’s
assessment body is suspended or withdrawn, conformity
representatives on the Joint Committee, established
assessment carried out by that body before the date of
under Article 12 of this Agreement, of the conformity
effect of the suspension or withdrawal shall remain valid
assessment bodies to be designated, suspended or with
unless either the responsible Party has limited or cancelled
drawn. The designation, suspension or withdrawal of
that validity, or the Joint Committee determines otherwise.
designation of conformity assessment bodies shall
The Party under whose jurisdiction the suspended or
take place in accordance with this Agreement and the
withdrawn conformity assessment body was operating
rules of procedure of the Joint Committee.’;
shall notify the other Party in writing of any such
changes relating to a limitation or cancellation of validity.’.
(b) paragraph 10 is replaced by the following:
8. Article 15 is amended as follows:
‘10. When
advising
their
Party’s
representative
on
the Joint Committee established under this Agreement,
of the conformity assessment bodies to be designated,
(a) paragraph 3 is replaced by the following:
the designating authority shall provide the following
details in respect of each conformity assessment body:
‘3. The Joint Committee may adopt Sectoral
Annexes to which Article 2 applies and which will
(a) the name;
provide the implementing arrangements for this Agree
ment.’;
(b) the postal address;
(b) paragraph 4 is replaced by the following:
(c) the facsimile (fax) number and e-mail address;
‘4. Amendments
to
the
Sectoral
Annexes,
and
the
(d) the range of products, processes, standards or
adoption of new Sectoral Annexes, shall be determined
services it is authorised to assess;
by the Joint Committee.’.
(e) the conformity assessment procedures it is auth
orised to carry out; and
9. The Annex is hereby amended as follows:
(f) the designation procedure used to determine
(a) paragraph 9 is replaced by the following:
competence.’.

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10. The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix
1 and Appendix 2, is replaced by the following:
‘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
SCOPE AND COVERAGE
1. The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in New
Zealand and in 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 auth
orisation 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 point 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 phar
maceutical 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 point 3(b) of Section III.
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 are used as a reference (in line with the provisions in point 3(b)
of Section III), 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 calendar days.

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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.
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 in international commerce. The certificate will detail
the agreed 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, 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
the Table.
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.
Applicable legislative, regulatory and administrative provisions for Applicable legislative, regulatory and administrative provisions
the European Union
for New Zealand
— Commission Directive 91/412/EEC of 23 July 1991 — Medicines Act, 1981
laying down the principles and guidelines of good
manufacturing practice for veterinary medicinal
products, as amended
— Medicines Regulations, 1984
— Directive 2001/82/EC of the European Parliament and — New Zealand Code of Good Manufacturing Practice
of the Council of 6 November 2001 on the
for Manufacture and Distribution of Therapeutic
Community code relating to veterinary medicinal
Goods, Parts 1, 2, 4 and 5
products, as amended
— Agricultural Compounds and Veterinary Medicines
— Directive 2001/83/EC of the European Parliament and
Act, 1997
of the Council of 6 November 2001 on the
Community code relating to medicinal products for
human use, as amended
— Agricultural Compounds and Veterinary Medicines
Regulations, 2001
— Commission Directive 2003/94/EC of 8 October
2003 laying down the principles and guidelines of — Agricultural Compounds and Veterinary Medicines
good manufacturing practice in respect of medicinal
(ACVM) Standard for Good Manufacturing Practice
products for human use and investigational medicinal
products for human use, as amended
— Agricultural Compounds and Veterinary Medicines
(ACVM) Guideline for Good Manufacturing Practice
— Regulation (EC) No 726/2004 of the European
Parliament and of the Council of 31 March 2004
laying down Community procedures for the authori — and any legislation adopted on the basis of, or that
sation and supervision of medicinal products for
amends, the above legislation
human and veterinary use and establishing a
European Medicines Agency, as amended
— Guide to Good Distribution Practice (94/C 63/03)
— Volume 4 — Guidelines for good manufacturing
practices for medicinal products for human and
veterinary use

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SECTION II
OFFICIAL INSPECTION SERVICES
The lists of official inspection services related to this Sectoral Annex have been jointly determined by the Parties and
will be maintained by them. If a Party requests from the other Party 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 calendar 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 point (2). 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 calendar 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).
(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) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general
GMP inspections (also regular, periodic, or routine inspections).
(b) ‘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/estab
lishment 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.

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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 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 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, counter
feiting 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 affect the protection of public health, is communicated to
the other Party 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

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For medicinal products for use in animals:
Director, Approvals and ACVM Standards
Ministry of Agriculture and Forestry
(MAF) PO Box 2526
Wellington 6140
New Zealand
Tel. 64-4-894 2541
Fax 64-4-894 2501
FOR THE EUROPEAN UNION: The
Director
of
the
European
Medicines
Agency
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.
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 point 7 of Section III.’.
11. The Sectoral Annex on medical devices is replaced by the following:
‘SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY — NEW ZEALAND
AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT
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) manufactured in New Zealand; and
(a) manufactured in the European Union; and
(b) subject to third party conformity assessment
(b) subject to third party conformity assessment
procedures, both product and quality systems-
procedures, both product and quality systems-
related; and
related, or subject to other requirements under
the legislation listed in Section I, as amended.
(c) provided for in Council Directive 90/385/EEC of
20 June 1990 on the approximation of the laws
of the Member States relating to active
implantable medical devices, as amended; and

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Products for export to the European Union Products
for
export
to
New
Zealand
(d) provided for in Council Directive 93/42/EEC of
14 June 1993 concerning medical devices, as
amended.
(2) For the purposes of paragraph 1:
(2) For the purposes of paragraph 1:
(a) medical devices provided for in the Appendix are
(a) medical devices provided for in the Appendix are
excluded; and
excluded; and
(b) unless otherwise provided for or by mutual
(b) unless otherwise provided for or by mutual
arrangement by the Parties, ‘manufacture’ of a
arrangement by the Parties, ‘manufacture’ of a
medical device does not include:
medical device does not include:
(i) restoration or renovation processes such as
(i) restoration or renovation processes such as
repairing, re-conditioning, overhauling or
repairing, re-conditioning, overhauling or
refurbishing; or
refurbishing; or
(ii) operations such as pressing, labelling,
(ii) operations such as pressing, labelling,
ticketing, packaging and preparation for
ticketing, packaging and preparation for
sale, conducted alone or in combination
sale, conducted alone or in combination
with each other; or
with each other; or
(iii) quality control inspections alone; or
(iii) quality control inspections alone; or
(iv) sterilisation alone.
(iv) sterilisation alone.
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
The legislative, regulatory and administrative requirements of the The legislative, regulatory and administrative requirements of
European Union with which New Zealand-designated conformity New Zealand with which European Union-designated conformity
assessment bodies will assess compliance
assessment bodies will assess compliance
— Council Directive 90/385/EEC of 20 June 1990 on — Radiocommunications Act 1989 and Regulations
the approximation of the laws of the Member States
made pursuant to that Act
relating to active implantable medical devices, as
amended
— 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
— and any European Union legislation adopted on the — Medicines Regulations 1984
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
For the conformity assessment bodies designated by the
Zealand
European Union
— Ministry of Health
— Belgium
Ministère de la Santé publique, de l’Environnement et
de l’Intégration sociale
Ministerie van Volksgezondheid, Leefmilieu en
Sociale Integratie

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For the conformity assessment bodies designated by New
For the conformity assessment bodies designated by the
Zealand
European Union
Agence Fédérale des Médicaments et des Produits de
Santé – Federaal Agentschap voor Geneesmiddelen en
Gezondheidsproducten
— Bulgaria
Държавна агенция за метрологичен и технически
надзор
— Czech Republic
ad pro technickou normalizaci, metrologii a státní
zkuebnictví
— Denmark
Indenrigs- og Sundhedsministeriet
Lgemiddelstyrelsen
— Germany
ZLG — Zentralstelle der Lnder für Gesund
heitsschutz bei Arzneimitteln und Medizinprodukten,
Bonn
ZLS — Zentralstelle der Lnder für Sicherheit
stechnik, München
— Estonia
Majandus- ja Kommunikatsiooniministeerium
— Ireland
Department of Health
Irish Medicines Board
— Greece
Υπουργεο Υγεα και Κοινωνικ Αλληλεγγη
Εθνικ Οργανισμ Φαρμκων
— Spain
Ministerio de Sanidad, Política Social e Igualdad
Agencia Espaola de Medicamentos y Productos Sani
tarios
— France
Ministère de la Santé
Agence Franaise de Sécurité Sanitaire des produits de
Santé
Agence Nationale du Médicament Vétérinaire
— Italy
Ministero della Salute – Dipartimento dell’ Inno
vazione – Direzione Generale Farmaci e Dispositivi
Medici
— Cyprus
The Drugs Council, Pharmaceutical Services (Ministry
of Health)
Veterinary Services (Ministry of Agriculture)

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For the conformity assessment bodies designated by New
For the conformity assessment bodies designated by the
Zealand
European Union
— Latvia
Zāu valsts aentūra
Veselības ministrija
— Lithuania
Lietuvos Respublikos sveikatos apsaugos ministerija
— Luxembourg
Ministère de la Santé
Division de la Pharmacie et des Médicaments
— Hungary
Országos Gyógyszerészeti Intézet
— Malta
Direttorat tal-Affarijiet Regolatorji, Awtorità Maltija
dwar l-iStandards
— Netherlands
Ministerie van Volksgezondheid, Welzijn en Sport
Inspectie voor de Gezondheidszorg
— Austria
Bundesministerium für Gesundheit
Bundesamt für Sicherheit im Gesundheitswesen
— Poland
Ministerstwo Zdrowia
Urzd Rejestracji Produktów Leczniczych, Wyrobów
Medycznych i Produktów Biobójczych
— Portugal
INFARMED:I.P. (Autoridade Nacional do Medic
amento e Produtos de Saúde, I.P.)
— Romania
Ministerul Sntii – Departament Dispozitive
Medicale
— Slovenia
Ministrstvo za zdravje
Javna agencija Republike Slovenije za zdravila in
medicinske pripomoke
— Slovakia
rad pre normalizáciu, metrológiu a skúobníctvo
Slovenskej republiky
— Finland
Sosiaali- ja terveysministeri
Sosiaali- ja terveysalan lupa- ja valvontavirasto
(Valvira)

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For the conformity assessment bodies designated by New
For the conformity assessment bodies designated by the
Zealand
European Union
— Sweden
Styrelsen fr ackreditering och teknisk kontroll
(SWEDAC)
— United Kingdom
Medicines and Healthcare products Regulatory
Agency
SECTION III
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
The procedures to be followed by New Zealand in designating
The procedures to be followed by the European Union in
conformity assessment bodies to assess products against the
designating conformity assessment bodies to assess products
European Union’s requirements
against New Zealand’s requirements
Conformity assessment bodies to be designated for the 1. The procedures for designating conformity assessment
purposes of this Sectoral Annex will meet the
bodies will be consistent with the principles and
requirements of the Directives listed in Section I, taking
procedures set out in the Annex to this Agreement.
into account Annex II to Decision No 768/2008/EC of
the European Parliament and of the Council of 9 July 2. The following procedures are deemed to be consistent
2008 on a common framework for the marketing of
with those set out in the Annex to this Agreement:
products, as amended, and be designated on the basis
of the procedures defined in the Annex to this
(a) Certification bodies:
Agreement. This may be demonstrated through:
— accredited by accreditation bodies which are
(a) Product certification bodies operating according to
signatories to the European cooperation for
the requirements of EN 45011 or ISO Guides 28
Accreditation (EA) Multilateral Agreement
and 40, and either:
(MLA) for certification of products,
— accredited by the Joint Accreditation System of
— members of the Worldwide System for
Australia and New Zealand (JAS-ANZ), or
Conformity Testing and Certification of Elec
trotechnical Equipment and Components
— able to demonstrate competence by other means
(IECEE) CB Scheme,
in accordance with Sections A and B of the
Annex to this Agreement.
— accredited by an accreditation body with
which JAS-ANZ has a mutual recognition
(b) Quality System certification bodies operating
agreement, or
according to the requirements of EN 45012 or ISO
Guide 62, and either:
— able to demonstrate competence by other
means in accordance with Section A and B
— accredited by JAS-ANZ, or
of the Annex to this Agreement.
— able to demonstrate competence by other means
(b) Testing laboratories:
in accordance with Sections A and B of the
Annex to this Agreement.
— accredited by accreditation bodies which are
signatories to the EA MLA for calibration
(c) Inspection bodies operating according to the
and testing laboratories,
requirements of ISO/IEC 17020, and either:
— recognised within the IECEE CB Scheme, or
— accredited by the Testing Laboratory Registration
Council of New Zealand or any other body estab
— able to demonstrate competence by other
lished by law in New Zealand which replaces it
means in accordance with Section A and B
and which has the same functions, or
of the Annex to this Agreement.
— able to demonstrate competence by other means Pursuant to point 5.2 of Section IV, designation for high-
in accordance with Sections A and B of the risk devices listed in point 5.1 of that Section will occur
Annex to this Agreement.
on the basis of a confidence-building programme.
Pursuant to point 5.2 of Section IV, designation for high-
risk devices listed in point 5.1 of that Section will occur
on the basis of a confidence-building programme.

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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:
— certificates withdrawn, suspended, restricted or revoked, and
— any legislation or amendment to existing legislation adopted on the basis of the legal texts listed in
Section I.
The contact points through which the information can be passed are:
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
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 Union European
Commission
Directorate-General for Health and Consumers
Rue de la Loi/Wetstraat 200
B-1049 Brussels
Tel. 32-2-299 11 11
The Parties may exchange information on the consequences of the establishment of the European Database on
Medical Devices (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 point 2 of Section III.
4. Recording
of
approvals
granted
In addition to the requirements imposed by the Annex to this Agreement on the 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 such 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.

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5. Confidence-building
with
respect
to
high-risk
devices
5.1. 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;
— medical devices that are implantable intra-ocular lenses;
— medical devices that are intra-ocular visco elastic fluids, and
— medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of
disease.
5.2. 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.
5.3. The
confidence-building
period
will
be
reviewed
after
two
years
commencing
from
the
date
this
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 latter 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
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;

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— 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 afore
mentioned medical devices.’.
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
Done at Brussels, in duplicate, on 23 February 2012 in the Bulgarian, Czech, Danish, Dutch, English,
Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish,
Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages, each text being equally authentic.

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За Европейския съюз
Por la Unión Europea
Za Evropskou unii
For Den Europiske Union
Für die Europische Union
Euroopa Liidu nimel
Για την Ευρωπακ νωση
For the European Union
Pour l'Union européenne
Per l'Unione europea
Eiropas Savienības vārdā –
Europos Sjungos vardu
Az Európai Unió részérl
Gall-Unjoni Ewropea
Voor de Europese Unie
W imieniu Unii Europejskiej
Pela Unio Europeia
Pentru Uniunea European
Za Európsku úniu
Za Evropsko unijo
Euroopan unionin puolesta
Fr Europeiska unionen
За Нοва Зeлaндия
Por Nueva Zelanda
Za Nov Zéland
For New Zealand
Für Neuseeland
Uus-Meremaa nimel
Για τη Nα Ζηλανδα
For New Zealand
Pour la Nouvelle-Zélande
Per la Nuova Zelanda
Jaunzēlandes vārdā –
Naujosios Zelandijos vardu
Uj-Zéland részérl
Gal New Zealand
Voor Nieuw-Zeeland
W imieniu Nowej Zelandii
Pela Nova Zelndia
Pentru Noua Zeeland
Za Nov Zéland
Za Novo Zelandijo
Unden-Seelannin puolesta
Fr Nya Zeeland

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