(ii) as soon as possible, transmits to the applicant the results of the conformity assessment procedure in an accurate and complete manner, so that the applicant can carry out any corrective action;
(iii) where the application is deficient, continue the procedure as far as possible, if the applicant so requests; and
(iv) inform the requester, upon request, of the status of the request and the reasons for any delay;
(g) limit the information to be submitted by the applicant to that necessary to assess conformity and to determine the appropriate cost of the assessment;
(h) to grant confidential information arising out of or submitted in connection with the procedure with respect to a good or service of the other Party:
(i) the same treatment as that accorded to information relating to a good or service of the Party; and (ii) treatment that protects the commercial interests of the applicant;
(j) ensure that any fee charged for assessing conformity of a good or service being exported from the other Party is equitable in relation to that charged for assessing conformity of an identical or similar good or service of the Party, taking into account communication, transportation and related costs;
(k) ensure that the location of the facilities where the conformity assessment procedures are carried out does not cause unnecessary inconvenience to the applicant or its representative;
(l) when possible, to try to assure that the procedure is carried out in the production facility of the good and that a conformity mark is granted, when appropriate;
(m) limit the procedure, in the case of a good or service that has been modified subsequent to a conformity assessment determination, to what is necessary to determine that the good or service continues to comply with those regulations or standards; and
(n) limit to reasonableness any requirement for samples of a good and ensure that the selection and collection of samples does not cause unnecessary inconvenience to the applicant or its representative.
4. The Parties shall apply the provisions of paragraph 3, with appropriate modifications, to their approval procedures.
5. Each Party shall give favorable consideration to the request of the other Party to negotiate agreements on the mutual recognition of the results of that Party's conformity assessment procedures.
Article 13-10. Metrological Standards.
The Parties shall make compatible, to the greatest extent possible, their metrological standards, taking as a basis the international standards in force, as stipulated in this Chapter.
Article 13-11. Health Protection.
1. Each Party shall ensure that the:
(a) medicines, medical equipment and instruments, pharmochemical goods and other inputs for human, animal or plant health;
(b) foodstuffs;
(c) cosmetics and perfumes;
(d) dangerous goods and substances; and
(e) goods, materials, radioactive sources and equipment, and sources and equipment emitting ionizing radiation,
which are subject to sanitary registration within the territory of a Party, shall, where appropriate, be registered, recognized or evaluated by the competent authority of that country, on the basis of a single national system of a federal or central character, as the case may be, of mandatory observance.
2. Certificates attesting that the enterprises producing or conditioning the goods referred to in paragraph 1 comply with the standards and technical regulations shall be accepted only if they have been issued by the competent regulatory agencies of the federal or central government, as the case may be.
3. The Parties shall establish a system of mutual technical cooperation that shall work on the basis of the following program:
(a) identification of specific needs relating to:
(i) to the application of good manufacturing practices in the manufacture and approval of medicines, particularly those for human use;
(ii) the application of good laboratory practices in the systems of analysis and evaluation established in the relevant international guidelines in force; and
(iii) the development of common identification and nomenclature systems for health auxiliary goods and medical instruments;
(b) standardization of labeling requirements, development and strengthening of, inter alia, standardization and surveillance systems in relation to warning labeling;
(c) development of training and education programs, and organization of, inter alia, a common system for the training, continuing education, training and evaluation of health officials and inspectors;
(d) development of a mutual accreditation system for verification units and testing laboratories;
(e) development and strengthening of formal communication systems to monitor and regulate the exchange of goods related to human, animal or plant health; and
(f) development, strengthening and promotion of cooperation in matters related to paragraphs 1 and 2.
4. The Sub-Working Group on Health Standardization Measures, established pursuant to Article 13-17, shall organize and follow up on the activities referred to in paragraph 3 and shall make appropriate recommendations to the Parties upon request.
Article 13-12. Protection of the Environment and Management of Hazardous Substances and Wastes.
1. For the care and protection of its environment, each Party shall apply the provisions, guidelines or recommendations of the United Nations Organization and of the relevant international agreements to which both Parties are parties, in addition to its legislation.
2. The Parties shall regulate and control the production, introduction and commercialization of pharmaceutical products, toxic agro-chemicals and other hazardous substances, in accordance with the provisions of this Treaty and those of their legislation.
3. Each Party shall regulate, in accordance with its legislation, the introduction, acceptance, deposit, transport and transit through its territory of hazardous, radioactive or other wastes of internal or external origin which, by their characteristics, constitute a danger to the health of the population or to the environment.
Article 13-13. Labeling.
1. In accordance with the provisions of this Chapter, each Party shall apply, within its territory, its relevant labeling requirements.
2. The Parties shall develop common labeling requirements through the Sub-Working Group on Standardization Measures on Labeling, Packaging, Packaging and Consumer Information established pursuant to paragraph 5 of Article 13-17.
3. The Sub-Working Subgroup shall formulate recommendations, among others, on the following matters:
(a) development of a common system of symbols and pictograms;
(b) definitions and terminology;
(c) presentation of information, including language, measurement systems, ingredients and sizes; and
(d) any other related matters.
Article 13-14. Notification, Publication and Provision of Information.
1. Each Party shall notify the other Party of the standardization and metrology measures it intends to establish before they enter into force and no later than to its nationals.
2. In addition to the provisions of Articles 17-02 (Publication) and 17-03 (Notification), to propose the adoption or modification of any standardization or metrology measure, each Party shall:
(a) shall publish a notice and notify the other Party in writing of its intention to adopt or modify such measure, so as to enable interested persons to familiarize themselves with the proposal, at least 60 days in advance of its adoption or modification, except in the case of any standardization measure relating to perishable goods, in which case, the Party shall, to the greatest extent possible, publish the notice and notify at least 30 days in advance of the adoption or modification of such measures and, in any case, simultaneously that its producers;
(b) identify in such notice and notification the good or service to which the measure is to be applied, and include a brief description of the objective and motivation of the measure;
(c) provide a copy of the proposed measure to the other Party or any interested person upon request and, where possible, identify the provisions that deviate in substance from the relevant international standards;
(d) without discrimination, allow the other Party and interested persons to make comments in writing and, upon request, discuss and take them and the results of the discussions into account; and
(e) ensure that, upon adoption of the measure, it is published expeditiously or otherwise made available to interested persons in the other Party to familiarize them with it.
3. Each Party shall endeavor to avoid maintaining in force or applying any technical regulations and conformity assessment procedures if the circumstances or objectives that gave rise to their adoption no longer exist, or can be met in a manner less restrictive to bilateral trade.
4. With respect to technical regulations other than those issued by the federal or central government, as the case may be, each Party shall:
(a) shall ensure that a notice is published and shall notify the other Party in writing of its intention to adopt or modify such a regulation at an appropriate initial stage;
(b) ensure that such notice and notification identifies the good or service to which the technical regulation will apply, and includes a brief description of the objective and rationale for the technical regulation;
(c) ensure that a copy of the proposed technical regulation is provided to the other Party or any interested person on request; and
(d) take such reasonable measures as may be available to it to ensure that when the technical regulation is adopted, it is published expeditiously or otherwise made available to interested persons in the other Party so that they may become familiar with it.
5. Where a Party considers it necessary to address an urgent problem relating to safety or to the protection of human, animal or plant life or health, the environment or to practices that mislead consumers, it may omit any of the steps set out in paragraph 2 or 4, provided that, when adopting the standardization measure:
(a) immediately notifies the other Party in accordance with the requirements set out in paragraph 2(b), including a brief description of the urgent problem;
(b) provides a copy of the measure to the other Party and to any interested person upon request;
(c) without discrimination, allow the other Party and interested persons to make comments in writing and, upon request, discuss and take them, and the results of the discussions, into account; and
(d) ensures that the measure is published expeditiously, or otherwise enables interested persons to become familiar with it.
6. The Parties shall allow a reasonable period between the publication of their standardization measures and the date on which they enter into force for interested persons to adapt to these measures, except where it is necessary to address one of the urgent problems identified in paragraph 5.
7. Each Party shall annually notify the other Party in writing of its standardization plans and programs.
8. Where a Party permits interested persons from outside the government to be present during the process of developing standardization measures, it shall also permit persons from outside the government of the other Party to be present.
9. Each Party shall designate a government authority to be responsible for the implementation of the notification provisions of this Chapter and shall notify the other Party. Where a Party designates two or more governmental authorities for this purpose, it shall inform the other Party precisely and fully of the scope of responsibilities of those authorities.
10. When a Party administratively rejects a shipment or provision of services on the grounds of non- compliance with a standardization measure, it shall inform, without delay and in writing, the person holding the shipment or the service provider of the technical justification for the rejection.
11. Once the information referred to in paragraph 10 has been generated, the Party shall immediately forward it to the information center or centers, in its territory, referred to in Article 13-15 in its territory, which, in turn, shall bring it to the attention of the information centers of the other Party.
Article 13-15. Information Centers.
1. Each Party shall ensure that there is at least one information center in its territory capable of responding to all reasonable inquiries and requests from the other Party and interested persons, as well as providing relevant documentation regarding:
(a) any standardization measures or metrological standards adopted or proposed in its territory;
(b) the membership and participation of that Party, or its relevant authorities, in international or regional standardizing bodies and conformity assessment systems, in bilateral or multilateral agreements, within the scope of this Chapter, as well as in relation to the provisions of those systems and agreements;
(c) the location of notices published in accordance with this chapter, or the place where the information contained therein may be obtained;
(d) the location of the information centers referred to in paragraph 3; and
(e) the Party's risk assessment procedures, the factors it takes into consideration in carrying out the assessment, and with the establishment of the levels of protection it considers appropriate, in accordance with paragraph 1 of Article 13-05.
2. Where a Party designates more than one information center:
(a) inform the other Party of the scope of responsibilities of each such center; and
(b) ensure that any request sent to the wrong enquiry point is expeditiously forwarded to the correct enquiry point.
3. Each Party shall take such reasonable measures as may be available to it to ensure that there is at least one information center, within its territory, capable of responding to all inquiries and requests from the other Party and interested persons, and of providing relevant documentation, or information where such documentation may be obtained, relating to:
(a) any standards or conformity assessment processes adopted or proposed by non-governmental standardizing bodies in its territory; and
(b) the membership and participation in international and regional standardizing bodies and conformity assessment systems of relevant non-governmental bodies in its territory.
4. Each Party shall ensure that, where the other Party or interested persons, in accordance with the provisions of this Chapter, request copies of the documents referred to in paragraph 1, they shall be provided at the same price that applies for domestic sale, except for the actual cost of shipment.
Article 13-16. Limitations on the Provision of Information.
Nothing in this Chapter shall be construed to impose an obligation on a Party to provide any information, the disclosure of which it considers contrary to the essential interests of its national security or of particular enterprises.
Article 13-17. Working Group on Standardization Measures.
1. The Parties establish the Working Group on Standardization Measures, composed of an equal number of representatives of each Party.
2. The functions of the Working Group include, among others:
(a) monitoring the implementation, compliance and administration of this Chapter, including the progress of the sub-working groups established pursuant to paragraph 5;
(b) facilitating the process through which the Parties will make their standardization and metrology measures compatible;
(c) to serve as a forum for the Parties to consult on matters related to standardization and metrology measures;
(d) promote technical cooperation activities between the Parties;
(e) assist in risk assessments carried out by the Parties;
(f) assist in developing and strengthening the standardization and evaluation systems of the Parties; and
(g) report annually to the Commission on the implementation of this Chapter.
3. The Working Group shall:
(a) shall meet at least once a year, unless otherwise agreed by the Parties;
(b) establish its rules of procedure; and
(c) make its decisions by consensus.
4. When the Working Group considers it appropriate, it may establish such sub-working groups as it deems appropriate and shall determine the scope and terms of reference of such sub-working groups. Each such sub-working group shall be composed of representatives of each Party and may:
(a) when it deems necessary, include or consult with:
(i) representatives of non-governmental bodies, such as standardization and metrology bodies or private sector chambers and associations;
(ii) scientists; and
(iii) technical experts; and
(b) determine its work program, taking into account relevant international activities.
5. In addition to the provisions of paragraph 4, the Working Group shall:
(a) establish:
(i) the Sub-Working Group on Health Standardization Measures;
(ii) the Sub-Working Group on Standardization Measures on Labeling, Packaging, Packaging and Consumer Information; and
(iii) the Sub-Working Group on Telecommunications; and
(b) any other working subgroups it deems appropriate to analyze, inter alia, the following topics:
(i) the identification and nomenclature of goods and services subject to standardization measures;
(ii) technical regulations and standards of quality and identity;
(iii) programs for the approval of goods and for post-sale surveillance;
(iv) principles for the accreditation and recognition of testing facilities, inspection agencies and conformity assessment bodies;
(v) the development and implementation of a uniform system for the classification and reporting of hazardous chemicals and the communication of chemical hazards;
(vi) programs to ensure compliance with the provisions in force, including training and inspection by personnel responsible for regulation, analysis and verification of compliance;
(vii) the promotion and application of good laboratory practices; viii) the promotion and application of good laboratory practices; viii) the promotion and application of good laboratory practices;
(viii) the promotion and application of good manufacturing practices; viii) the promotion and application of good manufacturing practices; viii) the promotion and application of good manufacturing practices;
(ix) criteria for the evaluation of potential damage to the environment due to the use of goods or services; x) analysis of procedures for the evaluation of potential damage to the environment due to the use of goods or services;
(x) analysis of procedures for the simplification of import requirements for specific goods;
(xi) guidelines for testing chemical substances, including industrial, agricultural, pharmaceutical, and biological substances; and
(xii) means of facilitating consumer protection, including consumer redress.
Article 13-18. Technical Cooperation.
1. At the request of a Party, the other Party may provide information or technical assistance, to the extent of its capabilities and on mutually agreed terms, in order to assist compliance with this Chapter and to strengthen the standardization and metrology activities, processes, systems and measures of that Party.
2. The activities referred to in paragraph 1 include:
(a) the identification of specific needs;
(b) training and capacity building programs;
(c) the development of a mutual accreditation system for verification units and testing laboratories;
(d) the development and strengthening of formal communication systems to monitor and regulate the exchange of goods and services; and
(e) information on technical cooperation programs related to standardization measures carried out by a Party.
3. In order to carry out the activities proposed in paragraph 2, the Parties shall establish the necessary mechanisms they deem appropriate, including those referred to in paragraph 4 of Article 13-17.
Article 13-19. Technical Consultations.
1. When a Party has doubts about the interpretation or application of this Chapter, about the standardization or metrology measures of the other Party or about measures related to them, the latter may refer to the Working Group or resort to the dispute settlement mechanism provided for in Chapter XIX (Dispute Settlement). The Parties may not use both avenues simultaneously.
2. When a Party decides to resort to the Working Group, it shall notify the Working Group so that it may consider the matter or refer it to a subworking group or other competent forum, with a view to obtaining non- binding technical advice or recommendations.
3. The Working Group shall consider any matter referred to it pursuant to paragraphs 1 and 2 as expeditiously as possible and shall bring to the attention of the Parties any technical advice or recommendations it develops or receives in connection with that matter. Upon receipt by the Parties of the requested technical advice or recommendation from the Working Group, the Parties shall provide a written response to the Working Group with respect to such technical advice or recommendation within a period to be determined by the Working Group.
4. In the event that the technical recommendation issued by the Working Group does not resolve the dispute between the Parties, the Parties may resort to the dispute settlement mechanism established in Chapter XIX. If the Parties so agree, consultations held before the Working Group shall constitute consultations for purposes of Article 19-04 (Consultations).
5. A Party asserting that a standards-related measure of the other Party is inconsistent with the provisions of this Chapter shall prove the inconsistency.
Chapter XIV. Government Procurement
Section A. Definitions
Article 14-01. Definitions
For purposes of this Chapter, the following definitions shall apply:
goods of the other Party: goods originating in the territory of the other Party, in accordance with Article 14- 05;
construction services contract: a contract for the performance, by whatever means, of civil works or construction referred to in the Appendix to Annex 6 to Article 14-02;
entity: an entity included in annexes 1 to 3 to article 14-02;
technical specification: a specification that establishes the characteristics of goods or processes and related production methods, or the characteristics of services or their related methods of operation, including the applicable administrative provisions. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements applicable to a good, process or method of production or operation;
bidding procedures: open, selective and restricted bidding procedures; open tendering procedures: those in which all interested suppliers may submit bids;