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EN
Official Journal of the European Union
29.12.2012
AGREEMENT
between the European Union and Australia amending the Agreement on mutual recognition in
relation to conformity assessment, certificates and markings between the European Community and
Australia
THE EUROPEAN UNION
and
AUSTRALIA,
hereinafter ‘the Parties’,
HAVING concluded the Agreement on mutual recognition in relation to conformity assessment, certificates and mark
ings ( 1 ) signed in Canberra on 24 June 1998 (hereinafter ‘the Agreement on Mutual Recognition’);
NOTING the need to simplify the operation of the Agreement on Mutual Recognition;
NOTING the need to clarify the status of the Sectoral Annexes 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;
WHEREAS Article 4 of the Agreement on Mutual Recognition restricts the application of the Agreement to industrial
products that originate in the Parties according to non-preferential rules of origin;
WHEREAS Article 12 of the Agreement 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;
RECOGNISING that the Parties may need to undertake certain domestic procedures before amendments to the Sectoral
Annexes or the adoption of new Sectoral Annexes take effect;
( 1 ) OJ L 229, 17.8.1998, p. 3.

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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 action on the recognition or withdrawal of recognition of conformity assessment bodies should be
limited to cases that have been contested by the other Party under Article 8 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 afterwards suspended or withdrawn
should be clarified,
HAVE AGREED AS FOLLOWS:
4. Article 7(1) is replaced by the following:
Article 1
‘1. The
Parties
shall
exchange
information
concerning
Amendments to the Agreement on Mutual Recognition
the procedures used to ensure that the designated
conformity assessment bodies under their responsibility
The Agreement on Mutual Recognition is hereby amended as
comply with the legislative, regulatory and administrative
follows:
requirements outlined in the Sectoral Annexes and the
competence requirements specified in the Annex.’.
1. Article 3(2) is replaced by the following:
5. Article 8 is amended as follows:
‘2. Each
Sectoral
Annex
shall,
in
general,
contain
the
following information:
(a) paragraph 3 is replaced by the following:
(a) a statement of its scope and coverage;
‘3. Such
contestation
has
to
be
justified
in
an
(b) the legislative, regulatory and administrative
objective and argued manner and in writing to the
requirements pertaining to the conformity assessment
other Party and to the Joint Committee.’;
procedures;
(c) the designating authorities;
(b) paragraph 6 is replaced by the following:
(d) a set of procedures for the designation of conformity
‘6. Except
when
decided
otherwise
by
the
Joint
assessment bodies, and
Committee, the contested conformity assessment body
shall be suspended by the competent designating
(e) additional provisions as required.’.
authority from the time its competence or compliance
is challenged until either agreement is reached in the
Joint Committee on the status of that body or the
2. Article 4 is replaced by the following:
challenging Party notifies the other Party and the
Joint Committee that it is satisfied as to the competence
‘Article 4
and compliance of that body.’.
Scope and coverage
This Agreement shall apply to the conformity assessment
6. Article 9 is replaced by the following:
of products specified in the statement of scope and
coverage in each Sectoral Annex.’.
‘Article 9
3. Article 6 is replaced by the following:
Exchange of information
1. The
Parties
shall
exchange
information
concerning
the
‘Article 6
implementation of the legislative, regulatory and adminis
trative provisions identified in the Sectoral Annexes and
Designating authorities
shall maintain an accurate list of conformity assessment
1. The
Parties
shall
ensure
that
the
designating
auth
bodies designated in accordance with this Agreement.
orities responsible for designating conformity assessment
bodies have the necessary power and competence to
2. Consistent
with
their
obligations
under
the
World
designate, suspend, remove the suspension of, and
Trade Organization Agreement on Technical Barriers to
withdraw the designation of, such bodies.
Trade, each Party shall inform the other Party of the
changes it intends to make to the legislative, regulatory
2. In
making
such
designations,
suspensions,
removals
and administrative provisions relating to the subject
of suspension and withdrawals, designating authorities
matter of this Agreement and shall, except as provided
shall, unless specified otherwise in the Sectoral Annexes,
for in paragraph 3 of this Article, notify the other Party
observe the procedures for designation set out in Article 12
of the new provisions at least 60 calendar days before their
and the Annex.’.
entry into force.

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3. Where
a
Party
takes
urgent
measures
that
it
considers
(a) a Party wishing to designate a conformity
warranted by considerations of safety, health or protection
assessment body shall forward its proposal to that
of the environment in order to eliminate an immediate risk
effect to the other Party in writing, adding
posed by a product covered by a Sectoral Annex, it shall
supporting documentation as defined by the Joint
notify the other Party of the measures and the reasons for
Committee;
their imposition immediately, or as otherwise specified in
the Sectoral Annex.’.
(b) in the event that the other Party consents to the
7. Article 12 is amended as follows:
proposal or upon the expiry of 60 calendar days
without an objection having been lodged in
(a) paragraphs 3 to 7 are replaced by the following:
accordance with the procedures of the Joint
Committee, the conformity assessment body shall
be considered to be a designated conformity
‘3. The
Joint
Committee
shall
meet
at
least
once
a
assessment body under the terms of Article 5;
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
(c) in the event that, under Article 8, the other Party
additional meeting or meetings shall be held.
contests the technical competence or compliance of
the proposed conformity assessment body within
4. The
Joint
Committee
may
consider
any
matter
the aforementioned 60-day period, the Joint
related to the functioning of this Agreement. In
Committee may decide to carry out a verification
particular, it shall be responsible for:
of the body concerned, in accordance with
Article 8;
(a) amending the Sectoral Annexes in accordance with
this Agreement;
(d) in the case of the designation of a new conformity
(b) exchanging information concerning the procedures
assessment body, conformity assessment carried out
used by either Party to ensure that the conformity
by such a body shall be valid from the date on
assessment bodies maintain the necessary level of
which it becomes a designated conformity
competence;
assessment body in accordance with this
Agreement;
(c) in accordance with Article 8, appointing a joint
team or teams of experts to verify the technical
(e) either Party may suspend, remove suspension or
competence of a conformity assessment body and
withdraw the designation of a conformity
its compliance with other relevant requirements;
assessment body under its jurisdiction. The Party
concerned shall immediately notify the other Party
(d) exchanging information and notifying the Parties of
and the Joint Committee of its decision in writing,
modifications of legislative, regulatory and adminis
together with the date of such decision. The
trative provisions referred to in the Sectoral
suspension, removal of suspension or withdrawal
Annexes, including those which require modifi
shall take effect from the date of the Party’s
cation of the Sectoral Annexes;
decision;
(e) resolving any questions relating to the application
of this Agreement and its Sectoral Annexes, and
(f) in accordance with Article 8, either Party may, in
exceptional circumstances, contest the technical
(f) adopting new Sectoral Annexes in accordance with
competence of a designated conformity assessment
this Agreement.
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
5. Any
amendments
to
the
Sectoral
Annexes
made
accordance with Article 8.
in accordance with this Agreement and any new
Sectoral Annexes adopted in accordance with this
Agreement shall be notified promptly in writing by
7. In the event that the designation of a conformity
the Joint Committee to each Party, and shall come
assessment body is suspended or withdrawn,
into effect for both Parties on the date on which the
conformity assessment carried out by that body
Joint Committee receives notification from each Party
before the date of effect of the suspension or with
confirming completion of their respective procedures
drawal shall remain valid unless either the responsible
for the amendments or new Sectoral Annex to take
Party has limited or cancelled that validity, or the Joint
effect, unless otherwise mutually determined in
Committee determines otherwise. The Party under
writing by the Parties.
whose jurisdiction the suspended or withdrawn
conformity assessment body was operating shall
6. The
following
procedure
shall
apply
in
relation
to
notify the other Party in writing of any such changes
the designation of a conformity assessment body:
relating to a limitation or cancellation of validity.’;

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(b) the following paragraph is added:
‘9. Designating
authorities
shall
inform
their
Party’s
representatives on the Joint Committee, established
‘9. The
Joint
Committee
shall
keep
the
Sectoral
under Article 12 of this Agreement, of the conformity
Annexes up-to-date and shall provide these to the
assessment bodies to be designated, suspended or with
Parties upon the amendments taking effect.’.
drawn. Designation, suspension or withdrawal of desig
nation of conformity assessment bodies shall take place
8. Article 15 is amended as follows:
in accordance with this Agreement and the rules of
procedure of the Joint Committee.’;
(a) paragraph 1 is replaced by the following:
(b) paragraph 10 is replaced by the following:
‘1. The Annex to this Agreement forms an integral
part thereof. The Sectoral Annexes form the adminis
‘10. When
advising
their
Party’s
representative
on
trative arrangements for the implementation of this
the Joint Committee established under this Agreement
Agreement and have less than treaty status.’;
of the conformity assessment bodies to be designated,
the designating authority shall provide the following
(b) paragraph 3 is replaced by the following:
details in respect of each conformity assessment body:
‘3. The Joint Committee may adopt Sectoral
(a) the name;
Annexes to which Article 2 applies and which will
provide the implementing arrangements for this Agree
(b) the postal address;
ment.’;
(c) 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 and come into effect in
accordance with Article 12(5).’.
(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-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION
TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
1. The Parties mutually establish that the provisions of this Sectoral Annex will cover all medicinal products which
are industrially manufactured in Australia and 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
Australia referred to in Section I. The definition of medicinal products includes all human and veterinary products,
such as chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products
derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs,
and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.
“GMP” is that part of quality assurance which ensures that products are consistently produced and controlled
during manufacture to the quality standards appropriate to their intended use and as required by the marketing
authorisation granted by the importing Party. For the purpose of this Sectoral Annex it includes the system
whereby the manufacturer receives the specification of the product and/or process from the marketing 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
mutually 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 may be used as a reference (in line with the provisions in point
3(b) of Section III), this is to be mentioned in the certificate.

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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.
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 in conformity with
GMP. The batch certificate will be signed by the person authorised to release the batch for sale or supply, i.e. in
the European Union the “qualified person” as referred to in relevant European Union legislation; in Australia, the
persons responsible for manufacturing quality control as specified in the relevant Australian 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 listed in
the Appendix.
However, the reference quality requirements of products to be exported, including their manufacturing method and
product specifications, will be those of the relevant product marketing authorisation granted by the importing Party.
SECTION II
OFFICIAL INSPECTION SERVICES
The lists of official inspection services related to this Sectoral Annex have been mutually established by the Parties
and will be maintained by them. If a Party requests 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 that request.
SECTION III
OPERATIONAL PROVISIONS
1. Transmission of inspection reports
Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the
manufacturing or control site, in case analytical operations are contracted out. The request may concern a “full
inspection report” or a “detailed report” (see 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.

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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
The Parties mutually acknowledge that each Party reserves the right to conduct its own inspection for reasons
identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the
option of joining the inspection. Recourse to this safeguard clause should be an exception. Should such an
inspection take place, inspection costs may be recovered.
7. Exchange of information between authorities and approximation of quality requirements
In accordance with the general provisions of 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 Australia 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.

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8. Official batch release
The official batch release procedure is an additional verification of safety and efficacy of immunological
medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the
distribution of each batch of product. This Agreement will not encompass this mutual recognition of official
batch releases. However, when an official batch release procedure applies, the manufacturer will provide, at the
request of the importing Party, the official batch release certificate if the batch in question has been tested by the
control authorities of the exporting Party.
For the European Union, the official batch release procedures for medicinal products for human use are
published by the European Directorate for the Quality of Medicines & HealthCare. For Australia, the official
batch release procedure is specified in document “WHO Technical Report Series, No 822, 1992”.
9. Inspectors’ training
In accordance with the general provisions of 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 agreed between the Parties to permit competent authorities and manufacturers to inform
the authorities of the other Party with the appropriate speed in case of quality defects, batch recalls, 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 mutually established.
The Parties will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation,
based on non-compliance with GMP and which could affect the protection of public health, 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, inspectors training sessions, technical requirements, will be:
FOR AUSTRALIA: For
medicinal
products
for
human
use:
The Head of Office
Therapeutic Goods Administration
Department of Health and Ageing
PO Box 100
Woden ACT 2606
Australia
Tel. 61-6-232-8622
Fax 61-6-232-8426
For medicinal products for use in animals:
The Manager, Manufacturing Quality and Licensing Section
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Australia
Tel. 61-6210-4803
Fax 61-6210-4741

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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 mutually recognise the need for this Sectoral Annex to accommodate change, particularly with regard to
the entry of new official inspection services or changes in the nature or role of established competent authorities.
Where significant changes have occurred with regard to official inspection services, the Joint Sectoral Group will
consider what, if any, additional information is required to verify programmes and establish or maintain mutual
recognition of inspections, in accordance with point 7 of Section III.
In accordance with this Agreement, the Australian veterinary medicinal product manufacturers will be inspected by
the Therapeutic Goods Administration (TGA) on behalf of the Australian Pesticides and Veterinary Medicines
Authority (APVMA), according to the current Australian code of GMP and the European Union GMP Guide for
veterinary medicinal products. The European Union will recognise the conclusions of inspections carried out by the
TGA and Australian manufacturers’ certifications of batch conformity. Should APVMA begin to carry out inspections
itself, inspection reports will also be routinely transmitted to the importing Party until there has been a satisfactory
verification of the APVMA GMP inspection programme.
Appendix
LIST OF APPLICABLE LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
For the European Union:
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufac
turing practice for veterinary medicinal products, as amended;
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code
relating to veterinary medicinal products, as amended;
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code
relating to medicinal products for human use, as amended;
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manu
facturing practice in respect of medicinal products for human use and investigational medicinal products for human
use, as amended;

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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down
Community procedures for the authorisation and supervision of medicinal products for 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.
For Australia:
For products for human use:
Therapeutic Goods Act 1989, and Regulations, Orders and Determinations thereunder, including Orders setting
standards such as labelling, the Determination establishing Manufacturing Principles and Australian Codes of
Good Manufacturing Practice.
For products for veterinary use:
Legislation — Commonwealth:
— Agricultural and Veterinary Chemicals (Administration) Act, 1992
— Agricultural and Veterinary Chemicals Act, 1994
— Agricultural and Veterinary Chemicals Code Act, 1994
— Agricultural and Veterinary Chemicals (Administration) Regulations, 1995
— Agricultural and Veterinary Chemicals Instrument No 1 (Manufacturing Principles), 2007
— Agricultural and Veterinary Chemicals Code Regulations, 1995
Legislation — New South Wales:
— Stock Foods Act, 1940
— Stock Medicines Act, 1989
— Public Health Act, 1991
— Poisons and Therapeutic Goods Act, 1966
— Pesticides Act, 1979
— Agricultural and Veterinary Chemicals (NSW) Act, 1994
including any regulations, orders or instruments made under the above legislation
Legislation — Victoria:
— Animal Preparations Act, 1987
— Health Act, 1958
— Drugs, Poisons and Controlled Substances Act, 1981
— Agricultural and Veterinary Chemicals (Victoria) Act, 1994

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including any regulations, orders or instruments made under the above legislation
Legislation — Queensland:
— Agricultural Standards Act, 1994
— Stock Act, 1915
— Health Act, 1937
— Agricultural and Veterinary Chemicals (Queensland) Act, 1994
including any regulations, orders or instruments made under the above legislation
Legislation — South Australia:
— Stock Medicines Act, 1939-1978
— Stock Foods Act, 1941
— Dangerous Substances Act, 1986
— Controlled Substances Act, 1984
— Stock Diseases Act, 1934
— Agricultural and Veterinary Chemicals (SA) Act, 1994
including any regulations, orders or instruments made under the above legislation
Legislation — Western Australia:
— Veterinary Preparations and Animal Feeding Stuffs Act, 1976–1982
— Poisons Act, 1964-1981
— Health Act, 1911
— Agricultural and Veterinary Chemicals (WA) Act, 1995
— Health (Pesticides) Regulations, 1956
including any regulations, orders or instruments made under the above legislation
Legislation — Tasmania:
— Veterinary Medicines Act, 1987
— Poisons Act, 1971
— Public Health Act, 1997
— Agricultural and Veterinary Chemicals (Tasmania) Act, 1994

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— Pesticides Act, 1968
including any regulations, orders or instruments made under the above legislation
Legislation — Northern Territory:
— Poisons and Dangerous Drugs Act, 1983
— Therapeutic Goods and Cosmetics Act, 1986
— Stock Diseases Act, 1954
— Agricultural and Veterinary Chemicals (NT) Act, 1994
including any regulations, orders or instruments made under the above legislation
Legislation — Australian Capital Territory
— Environment Protection Act, 1997
including any regulations, orders or instruments made under the above legislation.’.
11. The Sectoral Annex on medical devices is replaced by the following:
‘SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY-AUSTRALIA
AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT,
CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
The Parties mutually establish that the provisions of this Sectoral Annex will apply to the following products:
Products for export to the European Union Products
for
export
to
Australia
(1) All medical devices:
(1) All medical devices:
(a) manufactured in Australia; and
(a) manufactured in the European Union; and
(b) subject to third party conformity assessment
(b) subject to conformity assessment procedures,
procedures, both product- and quality systems-
both product- and quality systems-related,
related; and
under the Australian Therapeutic Goods Act
1989 and Therapeutic Goods Regulations, as
(c) provided for in Council Directive 90/385/EEC of
amended.
20 June 1990 on the approximation of the laws
of the Member States relating to active
implantable medical devices, as amended; and
(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
excluded; and
are 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:

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L 359/14
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Products for export to the European Union Products
for
export
to
Australia
(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
Legislative, regulatory and administrative requirements of the
Legislative, regulatory and administrative requirements of
European Union with which Australian-designated conformity
Australia 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 — Therapeutic Goods Act 1989, as amended
the approximation of the laws of the Member States
relating to active implantable medical devices, as — Therapeutic Goods Regulations 1990, as amended
amended
— Therapeutic Goods (Medical Devices) Regulations
— Council Directive 93/42/EEC of 14 June 1993
2002, as amended
concerning medical devices, as amended
— and any subordinate legislation referred to in the
— and any legislation adopted on the basis of these
above Acts or Regulations, as amended ( 1 )
Directives
( 1 ) General reference to Australia’s subordinate legislation referred to in the Therapeutic Goods Act and Regulations and to anticipate
any legislative changes.
SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
Conformity assessment bodies designated by Australia to assess
Conformity assessment bodies designated by the European
products against the European Union’s legislative, regulatory and Union to assess products against Australia’s legislative, regu
administrative requirements
latory and administrative requirements
The lists of designated conformity assessment bodies The lists of designated conformity assessment bodies
have been mutually established by the Parties and will have been mutually established by the Parties and will
be maintained by them.
be maintained by them.
SECTION III
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES FOR THE
PURPOSES OF THIS AGREEMENT
For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the Member
States of the European Union
— Department of Health and Ageing for the Therapeutic — Belgium
Goods Administration
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 Australia For the conformity assessment bodies designated by the Member
States of the 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 Medizinpro
dukten, 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
Sanitarios
— 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 Australia For the conformity assessment bodies designated by the Member
States of the 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 (Val
vira)

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For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the Member
States of the European Union
— Sweden
Styrelsen fr ackreditering och teknisk kontroll
(SWEDAC)
— United Kingdom
Medicines and Healthcare products Regulatory
Agency
SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
Procedures to be followed by Australia in designating conformity Procedures to be followed by the European Union in designating
assessment bodies to assess products against the European
conformity assessment bodies to assess products against
Union’s requirements
Australia’s requirements
The Therapeutic Goods Administration of the Conformity assessment bodies will meet the
Department of Health and Ageing will meet the requirements mentioned in the Directives listed in
requirements of the Directives listed in Section I, taking Section I, taking into account Decision No 768/2008/EC
into account Decision No 768/2008/EC of the European of the European Parliament and of the Council of 9 July
Parliament and of the Council of 9 July 2008 on a 2008 on a common framework for the marketing of
common framework for the marketing of products, as products, as amended, insofar as it refers to the modules
amended, insofar as it refers to the modules for the for the various phases of the conformity assessment
various phases of the conformity assessment procedures procedures and the rules for the affixing and use of
and the rules for the affixing and use of the CE the CE conformity marking, and be designated for
conformity marking, and be designated for specific specific categories or classes of devices and conformity
categories or classes of devices and conformity assessment procedures. For products covered by Section
assessment procedures. For products covered by Section V, designation will occur on the basis of a confidence-
V, designation will occur on the basis of a confidence- building programme as referred to in point 1.2 of
building programme as referred to in point 1.2 of Section V. ( 2 )
Section V. ( 1 )
( 1 ) Presumption of competence is following successful completion of confidence-building for Section V devices.
( 2 ) Presumption of competence is following successful completion of confidence-building for Section V devices.
SECTION V
ADDITIONAL PROVISIONS
1. Confidence-building
with
respect
to
high-risk
devices
1.1.
A confidence-building process for the purpose of strengthening confidence in the designating systems of each
of the Parties will apply for the following medical devices:
— active implantable devices as defined in the legislation referred to in Section I;
— devices that are classified as class III devices under the legislation referred to in Section I;
— 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.
1.2.
The Parties will establish a detailed programme to this effect involving the Therapeutic Goods Administration
and the European Union’s competent authorities.
1.3. The
confidence-building
period
will
be
reviewed
after
two
years
commencing
from
the
date
this
Sectoral
Annex, as amended, becomes effective.

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1.4. Additional
specific
requirements
for
regulatory
progress:
1.4.1. 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.
1.4.2. These specific requirements may include training, observed conformity assessment body audits, visits and
information and document exchange, including audit reports.
1.4.3. These requirements may likewise be applicable in relation to the designation of a conformity assessment
body in accordance with this Agreement.
2. Registration,
listing
and
inclusion
procedures
for
the
Australian
Register
of
Therapeutic
Goods
(ARTG)
2.1. The
Parties
recognise
that
Australian
procedures
under
the
Therapeutic
Goods
Act
1989
for
the
registration,
listing or inclusion of products for market surveillance purposes, and corresponding European Union
procedures, are unaffected by this Agreement.
2.2. Within
the
framework
of
this
Agreement,
the
Australian
Regulatory
Authority
will
without
delay
enter
a
product from the European Union on the ARTG without further assessment of the product. This is
contingent upon receipt of a product application accompanied by the prescribed fee and the conformity
assessment body’s certification to Australia’s requirements.
2.3. Any fees attached to registration by either Party will be related only to the costs of the medical device
registration, enforcement and post-market surveillance activities of the Parties in this sector.
3. Exchange
of
information
The Parties agree to inform each other of:
— certificates withdrawn, suspended, restricted or revoked;
— adverse events in the context of the GHTF medical device vigilance procedure;
— matters concerning product safety; and
— any legislation or amendment to existing legislation adopted on the basis of the legal texts listed in
Section I.
The Parties will establish contact points for each of these purposes.
The Parties will consider the consequences of the establishment of European Database on Medical Devices
(Eudamed).
In addition, the Therapeutic Goods Administration will advise of any certificates issued.
4. New
legislation
The Parties jointly note that Australia is to introduce new legislation concerning in vitro diagnostics (IVDs),
and that any new arrangements will respect the principles on which this Agreement is based.
The Parties mutually declare their plan to extend the scope of this Agreement to IVDs as soon as the
Australian legislation on IVDs is in place.
5. Measures
to
protect
public
health
and
safety
Implementation of this Sectoral Annex will not constrain a Party from taking measures necessary to protect
public health and safety, in accordance with the legislation referred to in Section I. Each Party will duly
inform the other Party of such measures.
6. Joint
Sectoral
Group
A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral
Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint
Committee as the latter will determine.

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The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its
recommendations by consensus. It may decide to delegate its tasks to subgroups.
7. Divergence
of
views
Both Parties will use their best endeavours to resolve any divergence of views. Unresolved divergences of view
will be referred to the Joint Sectoral Group.
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;
— 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 other
medical devices, except for sterilisers using dry heat, moist heat or ethylene oxide.
Both Parties may decide by mutual arrangement to extend the application of this Sectoral Annex to the 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 duplicate 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 Австралия
Por Australia
Za Austrálii
For Australien
Für Australien
Austraalia nimel
Για την Αυστραλα
For Australia
Pour l'Australie
Per l'Australia
Austrālijas vārdā –
Australijos vardu
Ausztrália nevében
Gall-Awstralja
Voor Australi
W imieniu Australii
Pela Austrália
Pentru Australia
Za Austráliu
V imenu Avstralije
Australian puolesta
Fr Australien

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