Article 1 
The Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia ("the Agreement") is hereby approved on behalf of the Union. The text of the Agreement is attached to this Decision. Article 2 The President of the Council shall designate the person empowered to proceed, on behalf of the Union, to transmitting the diplomatic notes provided for in Article 2 of the Agreement, in order to express the consent of the Union to be bound by the Agreement [4]. Article 3 This Decision shall enter into force on the day of its adoption. Done at Brussels, 18 July 2011. For the Council The President M. Dowgielewicz [1] OJ L 229, 17.8.1998, p. 3. [2] OJ L 5, 9.1.1999, p. 74. [3] OJ L 194, 26.7.2011, p. 1. [4] The date of entry into force of the Agreement will be published in the Official Journal of the European Union by the General Secretariat of the Council. 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 AUSTRALIA, hereinafter "the Parties", HAVING concluded the Agreement on mutual recognition in relation to conformity assessment, certificates and markings [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; 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: Article 1 Amendments to the Agreement on Mutual Recognition The Agreement on Mutual Recognition is hereby amended as follows: 1. Article 3(2) is replaced by the following: "2. Each Sectoral Annex shall, in general, contain the following information: (a) a statement of its scope and coverage; (b) the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures; (c) the designating authorities; (d) a set of procedures for the designation of conformity assessment bodies, and (e) additional provisions as required.". 2. Article 4 is replaced by the following: "Article 4 Scope and coverage This Agreement shall apply to the conformity assessment of products specified in the statement of scope and coverage in each Sectoral Annex.". 3. Article 6 is replaced by the following: "Article 6 Designating authorities 1. The Parties shall ensure that the designating authorities responsible for designating conformity assessment bodies have the necessary power and competence to designate, suspend, remove the suspension of, and withdraw the designation of, such bodies. 2. In making such designations, suspensions, removals of suspension and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.". 4. Article 7(1) is replaced by the following: "1. The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.". 5. Article 8 is amended as follows: (a) paragraph 3 is replaced by the following: "3. Such contestation has to be justified in an objective and argued manner and in writing to the other Party and to the Joint Committee."; (b) paragraph 6 is replaced by the following: "6. Except when decided otherwise by the Joint Committee, the contested conformity assessment body shall be suspended by the competent designating authority from the time its competence or compliance is challenged until either agreement is reached in the Joint Committee on the status of that body or the challenging Party notifies the other Party and the Joint Committee that it is satisfied as to the competence and compliance of that body.". 6. Article 9 is replaced by the following: "Article 9 Exchange of information 1. The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes and shall maintain an accurate list of conformity assessment bodies designated in accordance with this Agreement. 2. Consistent with their obligations under the World Trade Organization Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except as provided for in paragraph 3 of this Article, notify the other Party of the new provisions at least 60 calendar days before their entry into force. 3. Where a Party takes urgent measures that it considers warranted by considerations of safety, health or protection of the environment in order to eliminate an immediate risk posed by a product covered by a Sectoral Annex, it shall notify the other Party of the measures and the reasons for their imposition immediately, or as otherwise specified in the Sectoral Annex.". 7. Article 12 is amended as follows: (a) paragraphs 3 to 7 are replaced by the following: "3. The Joint Committee shall meet at least once a year unless the Joint Committee or the Parties decide otherwise. If required for the effective functioning of this Agreement, or at the request of either Party, an additional meeting or meetings shall be held. 4. The Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for: (a) amending the Sectoral Annexes in accordance with this Agreement; (b) exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies maintain the necessary level of competence; (c) in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements; (d) exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes, including those which require modification of the Sectoral Annexes; (e) resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and (f) adopting new Sectoral Annexes in accordance with this Agreement. 5. Any amendments to the Sectoral Annexes made in accordance with this Agreement and any new Sectoral Annexes adopted in accordance with this Agreement shall be notified promptly in writing by the Joint Committee to each Party, and shall come into effect for both Parties on the date on which the Joint Committee receives notification from each Party confirming completion of their respective procedures for the amendments or new Sectoral Annex to take effect, unless otherwise mutually determined in writing by the Parties. 6. The following procedure shall apply in relation to the designation of a conformity assessment body: (a) a Party wishing to designate a conformity assessment body shall forward its proposal to that effect to the other Party in writing, adding supporting documentation as defined by the Joint Committee; (b) in the event that the other Party consents to the proposal or upon the expiry of 60 calendar days without an objection having been lodged in accordance with the procedures of the Joint Committee, the conformity assessment body shall be considered to be a designated conformity assessment body under the terms of Article 5; (c) in the event that, under Article 8, the other Party contests the technical competence or compliance of the proposed conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8; (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 which it becomes a designated conformity assessment body in accordance with this Agreement; (e) either Party may suspend, remove suspension or withdraw the designation of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party and the Joint Committee of its decision in writing, together with the date of such decision. The suspension, removal of suspension or withdrawal shall take effect from the date of the Party’s decision; (f) in accordance with Article 8, either Party may, in exceptional circumstances, contest the technical competence of a designated conformity assessment body under the jurisdiction of the other Party. In this case the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8. 7. In the event that the designation of a conformity assessment body is suspended or withdrawn, conformity assessment carried out by that body before the date of effect of the suspension or withdrawal shall remain valid unless either the responsible Party has limited or cancelled that validity, or the Joint Committee determines otherwise. The Party under whose jurisdiction the suspended or withdrawn conformity assessment body was operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity."; (b) the following paragraph is added: "9. The Joint Committee shall keep the Sectoral Annexes up-to-date and shall provide these to the Parties upon the amendments taking effect.". 8. Article 15 is amended as follows: (a) paragraph 1 is replaced by the following: "1. The Annex to this Agreement forms an integral part thereof. The Sectoral Annexes form the administrative arrangements for the implementation of this Agreement and have less than treaty status."; (b) paragraph 3 is replaced by the following: "3. The Joint Committee may adopt Sectoral Annexes to which Article 2 applies and which will provide the implementing arrangements for this Agreement."; (c) paragraph 4 is replaced by the following: "4. Amendments to the Sectoral Annexes, and the adoption of new Sectoral Annexes, shall be determined by the Joint Committee and come into effect in accordance with Article 12(5).". 9. The Annex is hereby amended as follows: (a) paragraph 9 is replaced by the following: "9. Designating authorities shall inform their Party’s representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be designated, suspended or withdrawn. Designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with this Agreement and the rules of procedure of the Joint Committee."; (b) paragraph 10 is replaced by the following: "10. When advising their Party’s representative on the Joint Committee established under this Agreement of the conformity assessment bodies to be designated, the designating authority shall provide the following details in respect of each conformity assessment body: (a) the name; (b) the postal address; (c) the facsimile (fax) number and e-mail address; (d) the range of products, processes, standards or services it is authorised to assess; (e) the conformity assessment procedures it is authorised to carry out, and (f) the designation procedure used to determine competence.". 10. The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix 1 and Appendix 2, is replaced by the following:
Article 2 
The President of the Council shall designate the person empowered to proceed, on behalf of the Union, to transmitting the diplomatic notes provided for in Article 2 of the Agreement, in order to express the consent of the Union to be bound by the Agreement [4]. Article 3 This Decision shall enter into force on the day of its adoption. Done at Brussels, 18 July 2011. For the Council The President M. Dowgielewicz [1] OJ L 229, 17.8.1998, p. 3. [2] OJ L 5, 9.1.1999, p. 74. [3] OJ L 194, 26.7.2011, p. 1. [4] The date of entry into force of the Agreement will be published in the Official Journal of the European Union by the General Secretariat of the Council. 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 AUSTRALIA, hereinafter "the Parties", HAVING concluded the Agreement on mutual recognition in relation to conformity assessment, certificates and markings [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; 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: Article 1 Amendments to the Agreement on Mutual Recognition The Agreement on Mutual Recognition is hereby amended as follows: 1. Article 3(2) is replaced by the following: "2. Each Sectoral Annex shall, in general, contain the following information: (a) a statement of its scope and coverage; (b) the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures; (c) the designating authorities; (d) a set of procedures for the designation of conformity assessment bodies, and (e) additional provisions as required.". 2. Article 4 is replaced by the following: "Article 4 Scope and coverage This Agreement shall apply to the conformity assessment of products specified in the statement of scope and coverage in each Sectoral Annex.". 3. Article 6 is replaced by the following: "Article 6 Designating authorities 1. The Parties shall ensure that the designating authorities responsible for designating conformity assessment bodies have the necessary power and competence to designate, suspend, remove the suspension of, and withdraw the designation of, such bodies. 2. In making such designations, suspensions, removals of suspension and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.". 4. Article 7(1) is replaced by the following: "1. The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.". 5. Article 8 is amended as follows: (a) paragraph 3 is replaced by the following: "3. Such contestation has to be justified in an objective and argued manner and in writing to the other Party and to the Joint Committee."; (b) paragraph 6 is replaced by the following: "6. Except when decided otherwise by the Joint Committee, the contested conformity assessment body shall be suspended by the competent designating authority from the time its competence or compliance is challenged until either agreement is reached in the Joint Committee on the status of that body or the challenging Party notifies the other Party and the Joint Committee that it is satisfied as to the competence and compliance of that body.". 6. Article 9 is replaced by the following: "Article 9 Exchange of information 1. The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes and shall maintain an accurate list of conformity assessment bodies designated in accordance with this Agreement. 2. Consistent with their obligations under the World Trade Organization Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except as provided for in paragraph 3 of this Article, notify the other Party of the new provisions at least 60 calendar days before their entry into force. 3. Where a Party takes urgent measures that it considers warranted by considerations of safety, health or protection of the environment in order to eliminate an immediate risk posed by a product covered by a Sectoral Annex, it shall notify the other Party of the measures and the reasons for their imposition immediately, or as otherwise specified in the Sectoral Annex.". 7. Article 12 is amended as follows: (a) paragraphs 3 to 7 are replaced by the following: "3. The Joint Committee shall meet at least once a year unless the Joint Committee or the Parties decide otherwise. If required for the effective functioning of this Agreement, or at the request of either Party, an additional meeting or meetings shall be held. 4. The Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for: (a) amending the Sectoral Annexes in accordance with this Agreement; (b) exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies maintain the necessary level of competence; (c) in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements; (d) exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes, including those which require modification of the Sectoral Annexes; (e) resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and (f) adopting new Sectoral Annexes in accordance with this Agreement. 5. Any amendments to the Sectoral Annexes made in accordance with this Agreement and any new Sectoral Annexes adopted in accordance with this Agreement shall be notified promptly in writing by the Joint Committee to each Party, and shall come into effect for both Parties on the date on which the Joint Committee receives notification from each Party confirming completion of their respective procedures for the amendments or new Sectoral Annex to take effect, unless otherwise mutually determined in writing by the Parties. 6. The following procedure shall apply in relation to the designation of a conformity assessment body: (a) a Party wishing to designate a conformity assessment body shall forward its proposal to that effect to the other Party in writing, adding supporting documentation as defined by the Joint Committee; (b) in the event that the other Party consents to the proposal or upon the expiry of 60 calendar days without an objection having been lodged in accordance with the procedures of the Joint Committee, the conformity assessment body shall be considered to be a designated conformity assessment body under the terms of Article 5; (c) in the event that, under Article 8, the other Party contests the technical competence or compliance of the proposed conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8; (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 which it becomes a designated conformity assessment body in accordance with this Agreement; (e) either Party may suspend, remove suspension or withdraw the designation of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party and the Joint Committee of its decision in writing, together with the date of such decision. The suspension, removal of suspension or withdrawal shall take effect from the date of the Party’s decision; (f) in accordance with Article 8, either Party may, in exceptional circumstances, contest the technical competence of a designated conformity assessment body under the jurisdiction of the other Party. In this case the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8. 7. In the event that the designation of a conformity assessment body is suspended or withdrawn, conformity assessment carried out by that body before the date of effect of the suspension or withdrawal shall remain valid unless either the responsible Party has limited or cancelled that validity, or the Joint Committee determines otherwise. The Party under whose jurisdiction the suspended or withdrawn conformity assessment body was operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity."; (b) the following paragraph is added: "9. The Joint Committee shall keep the Sectoral Annexes up-to-date and shall provide these to the Parties upon the amendments taking effect.". 8. Article 15 is amended as follows: (a) paragraph 1 is replaced by the following: "1. The Annex to this Agreement forms an integral part thereof. The Sectoral Annexes form the administrative arrangements for the implementation of this Agreement and have less than treaty status."; (b) paragraph 3 is replaced by the following: "3. The Joint Committee may adopt Sectoral Annexes to which Article 2 applies and which will provide the implementing arrangements for this Agreement."; (c) paragraph 4 is replaced by the following: "4. Amendments to the Sectoral Annexes, and the adoption of new Sectoral Annexes, shall be determined by the Joint Committee and come into effect in accordance with Article 12(5).". 9. The Annex is hereby amended as follows: (a) paragraph 9 is replaced by the following: "9. Designating authorities shall inform their Party’s representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be designated, suspended or withdrawn. Designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with this Agreement and the rules of procedure of the Joint Committee."; (b) paragraph 10 is replaced by the following: "10. When advising their Party’s representative on the Joint Committee established under this Agreement of the conformity assessment bodies to be designated, the designating authority shall provide the following details in respect of each conformity assessment body: (a) the name; (b) the postal address; (c) the facsimile (fax) number and e-mail address; (d) the range of products, processes, standards or services it is authorised to assess; (e) the conformity assessment procedures it is authorised to carry out, and (f) the designation procedure used to determine competence.". 10. The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix 1 and Appendix 2, is replaced by the following:
Article 3 
This Decision shall enter into force on the day of its adoption. Done at Brussels, 18 July 2011. For the Council The President M. Dowgielewicz [1] OJ L 229, 17.8.1998, p. 3. [2] OJ L 5, 9.1.1999, p. 74. [3] OJ L 194, 26.7.2011, p. 1. [4] The date of entry into force of the Agreement will be published in the Official Journal of the European Union by the General Secretariat of the Council. 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 AUSTRALIA, hereinafter "the Parties", HAVING concluded the Agreement on mutual recognition in relation to conformity assessment, certificates and markings [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; 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: Article 1 Amendments to the Agreement on Mutual Recognition The Agreement on Mutual Recognition is hereby amended as follows: 1. Article 3(2) is replaced by the following: "2. Each Sectoral Annex shall, in general, contain the following information: (a) a statement of its scope and coverage; (b) the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures; (c) the designating authorities; (d) a set of procedures for the designation of conformity assessment bodies, and (e) additional provisions as required.". 2. Article 4 is replaced by the following: "Article 4 Scope and coverage This Agreement shall apply to the conformity assessment of products specified in the statement of scope and coverage in each Sectoral Annex.". 3. Article 6 is replaced by the following: "Article 6 Designating authorities 1. The Parties shall ensure that the designating authorities responsible for designating conformity assessment bodies have the necessary power and competence to designate, suspend, remove the suspension of, and withdraw the designation of, such bodies. 2. In making such designations, suspensions, removals of suspension and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.". 4. Article 7(1) is replaced by the following: "1. The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.". 5. Article 8 is amended as follows: (a) paragraph 3 is replaced by the following: "3. Such contestation has to be justified in an objective and argued manner and in writing to the other Party and to the Joint Committee."; (b) paragraph 6 is replaced by the following: "6. Except when decided otherwise by the Joint Committee, the contested conformity assessment body shall be suspended by the competent designating authority from the time its competence or compliance is challenged until either agreement is reached in the Joint Committee on the status of that body or the challenging Party notifies the other Party and the Joint Committee that it is satisfied as to the competence and compliance of that body.". 6. Article 9 is replaced by the following: "Article 9 Exchange of information 1. The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes and shall maintain an accurate list of conformity assessment bodies designated in accordance with this Agreement. 2. Consistent with their obligations under the World Trade Organization Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except as provided for in paragraph 3 of this Article, notify the other Party of the new provisions at least 60 calendar days before their entry into force. 3. Where a Party takes urgent measures that it considers warranted by considerations of safety, health or protection of the environment in order to eliminate an immediate risk posed by a product covered by a Sectoral Annex, it shall notify the other Party of the measures and the reasons for their imposition immediately, or as otherwise specified in the Sectoral Annex.". 7. Article 12 is amended as follows: (a) paragraphs 3 to 7 are replaced by the following: "3. The Joint Committee shall meet at least once a year unless the Joint Committee or the Parties decide otherwise. If required for the effective functioning of this Agreement, or at the request of either Party, an additional meeting or meetings shall be held. 4. The Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for: (a) amending the Sectoral Annexes in accordance with this Agreement; (b) exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies maintain the necessary level of competence; (c) in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements; (d) exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes, including those which require modification of the Sectoral Annexes; (e) resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and (f) adopting new Sectoral Annexes in accordance with this Agreement. 5. Any amendments to the Sectoral Annexes made in accordance with this Agreement and any new Sectoral Annexes adopted in accordance with this Agreement shall be notified promptly in writing by the Joint Committee to each Party, and shall come into effect for both Parties on the date on which the Joint Committee receives notification from each Party confirming completion of their respective procedures for the amendments or new Sectoral Annex to take effect, unless otherwise mutually determined in writing by the Parties. 6. The following procedure shall apply in relation to the designation of a conformity assessment body: (a) a Party wishing to designate a conformity assessment body shall forward its proposal to that effect to the other Party in writing, adding supporting documentation as defined by the Joint Committee; (b) in the event that the other Party consents to the proposal or upon the expiry of 60 calendar days without an objection having been lodged in accordance with the procedures of the Joint Committee, the conformity assessment body shall be considered to be a designated conformity assessment body under the terms of Article 5; (c) in the event that, under Article 8, the other Party contests the technical competence or compliance of the proposed conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8; (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 which it becomes a designated conformity assessment body in accordance with this Agreement; (e) either Party may suspend, remove suspension or withdraw the designation of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party and the Joint Committee of its decision in writing, together with the date of such decision. The suspension, removal of suspension or withdrawal shall take effect from the date of the Party’s decision; (f) in accordance with Article 8, either Party may, in exceptional circumstances, contest the technical competence of a designated conformity assessment body under the jurisdiction of the other Party. In this case the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8. 7. In the event that the designation of a conformity assessment body is suspended or withdrawn, conformity assessment carried out by that body before the date of effect of the suspension or withdrawal shall remain valid unless either the responsible Party has limited or cancelled that validity, or the Joint Committee determines otherwise. The Party under whose jurisdiction the suspended or withdrawn conformity assessment body was operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity."; (b) the following paragraph is added: "9. The Joint Committee shall keep the Sectoral Annexes up-to-date and shall provide these to the Parties upon the amendments taking effect.". 8. Article 15 is amended as follows: (a) paragraph 1 is replaced by the following: "1. The Annex to this Agreement forms an integral part thereof. The Sectoral Annexes form the administrative arrangements for the implementation of this Agreement and have less than treaty status."; (b) paragraph 3 is replaced by the following: "3. The Joint Committee may adopt Sectoral Annexes to which Article 2 applies and which will provide the implementing arrangements for this Agreement."; (c) paragraph 4 is replaced by the following: "4. Amendments to the Sectoral Annexes, and the adoption of new Sectoral Annexes, shall be determined by the Joint Committee and come into effect in accordance with Article 12(5).". 9. The Annex is hereby amended as follows: (a) paragraph 9 is replaced by the following: "9. Designating authorities shall inform their Party’s representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be designated, suspended or withdrawn. Designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with this Agreement and the rules of procedure of the Joint Committee."; (b) paragraph 10 is replaced by the following: "10. When advising their Party’s representative on the Joint Committee established under this Agreement of the conformity assessment bodies to be designated, the designating authority shall provide the following details in respect of each conformity assessment body: (a) the name; (b) the postal address; (c) the facsimile (fax) number and e-mail address; (d) the range of products, processes, standards or services it is authorised to assess; (e) the conformity assessment procedures it is authorised to carry out, and (f) the designation procedure used to determine competence.". 10. The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix 1 and Appendix 2, is replaced by the following: