4. In accordance with paragraph 3, each Party may develop, adopt, maintain and implement measures related to standardization to ensure their level of protection as well as measures to ensure the implementation and enforcement of such measures related to standardization, including approval procedures.
5. In relation to its measures relating to standardization, each Party shall accord to the goods and services from the territory of the other party National Treatment no less favourable than that accorded to similar goods and services from any other country.
Article 14-05. Use of International Standards
1. Each Party shall, as a basis for their own measures related to international standards, standardization, existing or imminent, or their parts, except where such relevant standards do not constitute an effective or appropriate means for achieving their legitimate objectives; for instance because of fundamental climatic or geographical nature or technological infrastructure, in accordance with this chapter.
2. It shall be presumed that measures relating to the standardization of a party which conforms to an international standard shall be consistent with the provisions of paragraphs 1, 2 and 5 of Article 14-04.
3. In pursuing its legitimate objectives, each Party may adopt or maintain any measure on standardisation applied to achieve a high level of protection to which would have been obtained if the measure based on an international standard due, among other factors, nature of fundamental climatic or geographical, technological infrastructure.
Article 14-06. Compatibility and Equivalence
1. Recognizing the central role of measures related to standardization in the promotion and protection of the legitimate objectives, the parties shall work together in accordance with this chapter, to strengthen the level of safety or of protection of human life and health, animal and plant, of their environment and the prevention of practices which may mislead consumers.
2. The Parties shall make compatible to the maximum extent possible, their respective technical regulations and conformity assessment procedures, without reducing the level of safety or of protection of human life and health, animal and plant, the environment or to consumers, without prejudice to the rights conferred by any party in this chapter and taking into account international standardization activities.
3. At the request of a party the other party shall take reasonable measures to promote the compatibility of the measures related to specific standardization that exist in its territory, to measures relating to the normalization that exist in the territory of the other party, taking into account international standardization activities.
4. Each Party shall accept a technical regulation to adopt or maintain the other party as equivalent to its own where, in cooperation with the importing Party and the exporting party proves to the satisfaction of the visit, that its Technical Regulation adequately complies with the legitimate objectives of the importing Party, and, where appropriate, revise it. at the request of the exporting party and the importing Party shall provide written reasons for not accepting a technical regulation as equivalent.
5. Each Party shall, whenever possible, shall accept the results of conformity assessment procedures conducted in the territory of the other party, even where these procedures differ from those provided that those procedures offer satisfactory, equivalent to an assurance that the procedures provided that the party carrying out or to be carried out in their territory which accepts that the good or service complies with the relevant applicable technical regulations or standards developed or maintained in the territory of that Party and, where appropriate, revise the relevant measure on standardisation.
6. Prior to accepting the results of a conformity assessment procedure in accordance with paragraph 5, and in order to build confidence in the integrity of the results of conformity assessment of each of the Parties may consult on matters such as the technical capacity of conformity assessment bodies, taking into account the verified compliance with relevant international standards and recommendations.
Article 14-07. Conformity Assessment
1. The Parties recognise the desirability of achieving mutual recognition of their conformity assessment systems, including bodies accredited by the entity concerned to facilitate trade in goods and services between them and undertake to work towards the achievement of this objective.
2. In addition to paragraph 1, and recognizing the existence of differences in their conformity assessment procedures in their respective territories, the Parties shall make compatible with the highest possible degree of their respective systems and conformity assessment procedures, so that they are mutually recognisable pursuant to this chapter.
3. For the mutual benefit of the Parties and reciprocally, each party through the competent institutions:
a) assess and recognize the national accreditation system of the other Party; and
b) credit, approve, license or recognize conformity assessment bodies in the territory of the other Party on terms no less favorable than those granted to such bodies in its territory.
4. Each Party shall give sympathetic consideration to applications submitted by the other party to negotiate agreements for the mutual recognition of the results of conformity assessment procedures of that Party.
5. When required to carry out any procedure of conformity assessment, each Party shall have the obligation to:
a) Not adopt or maintain more stringent procedures for assessment of conformity and not to apply stricter than necessary to ensure that the good or service conforms to the technical standards or applicable regulations, taking into account the risk that non-conformity would create.
b) Initiate and complete the procedure as expeditiously as possible;
c) Establish a non-discriminatory order for the processing of applications;
d) Publish the normal period of each procedure or communicate, at the request of the applicant, the approximate duration of the procedure;
e) Ensure that the competent body:
i) Upon receipt of a request, consider promptly make the documentation is complete and informs the applicant in a precise and complete manner of any deficiency;
ii) As soon as practicable the applicant to transmit the results of the conformity assessment procedure in a complete and precise so that the applicant may carry out any corrective action;
iii) Where the application is inadequate, the procedure where possible, if the applicant so requests; and
iv) Report of the applicant at the request of the status of the application and the reasons for any delay;
f) Limited to what is necessary, and in accordance with its applicable legislation, the applicant must submit information to assess conformity and to determine the relevant rights;
g) Accord confidential information from the procedure or that are present in relation to:
i) The same treatment as the information concerning a product or service; and
ii) In any case, treatment to protect the legitimate commercial interests of the applicant;
h) Ensure that the amount of any right to raise for assessing the conformity of a good or service that is exported from the other party, not more than any right to raise for assessing the conformity of a good or service National identical or similar, taking into consideration the costs of communication, transportation and other related costs;
i) Ensure that the location of facilities which are carried out at conformity assessment procedures do not cause unnecessary inconvenience to an applicant or his representative;
j) Where possible, ensure that the procedure is conducted by that installation and, where appropriate, a mark of conformity;
k) Limiting the procedure for a good or service that has been amended as a result of a determination of the conformity assessment, to that necessary to determine that the good or service is complying with applicable technical standards or regulations; and
l) A reasonable limit any requirement regarding samples of a good and ensure that the selection of samples does not cause unnecessary inconvenience to an applicant or his representative, in accordance with the procedures adopted at international level and sampling.
6. The Parties shall apply the provisions of paragraph 5 to its approval procedures, with such modifications as appropriate.
7. At the request of a party the other party shall take such reasonable measures as may be available to it to facilitate the implementation of the conformity assessment activities.
Article 14-08. Provision of Information, Notification and Publication
1. Each Party shall notify the other party before the Entry into Force and not later than its nationals, on measures concerning standardization which shall seek to establish as stated in this chapter.
2. The proposing the adoption or modification of any measure on standardisation, each Party shall:
a) Publish a notice and notify the other party in writing of its intention to adopt or amend such measure at least 60 days prior to the adoption or modification, so as to enable interested persons to become acquainted with the proposed, except in cases of any measure on standardisation related to perishable goods, in which case the party, in the best extent possible, publish a notice and notify the other party at least 30 days prior to the adoption or amendment of such measure, but simultaneously be notified to domestic producers;
b) Identify in the notice and notification to the good or service which shall apply the measure, and include a brief description of the objective and the reasons for such action.
c) A copy of the proposed measure to the other party and at the request of any interested person and, where possible, shall identify the provisions which differ substantially from relevant international standards;
d) Without discrimination as will enable the Party and other interested persons to make comments in writing and shall, upon request, discuss and take these comments into account and the results of the discussions; and
e) Ensure that in taking the measure, it shall expeditiously publish or otherwise make available to interested persons in the Party to become acquainted with them.
3. Where there is a relevant international standard or which is imminent for issuing a measure on standardisation proposal, or on standardisation such measure is not substantially the same as an international standard, and where the measure on standardisation may have a significant effect on trade between the parties, each Party shall:
a) Shall publish a notice and notification of the type required in subparagraphs (a) and (b) of paragraph 2, at an early and appropriate;
b) Shall observe the provisions of subparagraphs (c) and (d) of paragraph 2.
4. As regards the technical regulations of the State, regional and municipal governments, each Party shall:
a) It shall publish a notice and notify the other party in writing of its intention to adopt or amend this regulation at an early appropriate;
b) Ensure that notice is identified in the notification and the good or service to which they apply the technical regulation, and include a brief description of the objective and motivation of such regulations;
c) Ensure that re-delivered a copy of the proposed regulation to the other party and to any interested person upon request; and
d) It shall take such reasonable measures as may be available to it to ensure that the adoption of the technical regulation, it shall expeditiously publish or otherwise make available to interested persons in the Party to become acquainted with them.
5. Each Party shall each year to the other party of its standardization plans and programmes.
6. Where a Party considers it necessary to address an urgent problem relating to security or for the protection of life and human, animal and plant health, the environment or practices that mislead consumers, it may omit any step set out in subparagraphs (a) and (b) of paragraph 2, provided that, in adopting the measure on standardisation:
a) Immediately notify the other Party in accordance with the requirements set out in subparagraph 2 (b), including a brief description of the urgent problem;
b) Re-delivered a copy of the measure to any interested party or that person so requests;
c) Without discrimination as to enable the Party and other interested persons to make comments in writing and, upon request, discuss and take into account the comments and the results of the discussions; and
d) Ensure that the measure is published expeditiously, or to enable interested persons to become acquainted with them.
7. The Parties shall allow a reasonable period between the publication of its measures relating to standardization and the date of entry into force, if there is a time for interested persons to conform to these measures related to standardization, except where necessary to address an urgent problems identified in paragraph 6.
8. Where a Party allows persons outside its territory to be present during the process of development of measures related to standardization, shall also allow persons who are present in the territory of the other party that do not belong to the Government.
9. Each Party shall designate a government authority responsible for the implementation of the provisions of the notification of this chapter for federal or central and shall notify the other Party no later than three months after the Entry into Force of this Treaty. where a Party designates two or more government authorities for this purpose, it shall inform the other party or exceptions, unambiguously on the scope of responsibility of those authorities.
10. When a Party administratively refuses a shipment or the provision of services by reason of that breach of a measure on standardisation, it shall inform without delay and in writing to the person of lading or the service provider the technical justification for rejection.
11. Once generated the information referred to in paragraph 10, it shall be immediately transmitted the information centre of measures related to standardization located in the territory of that Party, which, in turn, will be communicated to the information centre of the other party.
Article 14-09. Information Centres
1. Each Party shall ensure that there is at least an information centre within its territory able to answer questions and all reasonable requests of the Party and other interested persons and provide the relevant documentation in relation to:
a) Any measure related to standardization adopted or proposed in its territory of its state or federal or central, regional or local government;
b) The membership and participation of that party and their relevant authorities at the central or federal, state or local or regional bodies in standardisation and conformity assessment systems international or regional, bilateral or multilateral agreements within the scope of this chapter and the provisions of those systems and arrangements;
c) The location of notices published pursuant to this chapter, or where such information can be obtained;
d) The location of information centres; and
e) The processes of risk assessment of the Party and the factors it takes into consideration for conducting the assessment and in establishing the levels of protection that it considers appropriate in accordance with paragraph 3 of article 14 -
2. Where a Party designates more of an information centre:
a) It shall inform the other party complete and unambiguous, on the scope of responsibility of each such centres; and
b) Ensure that any request sent the wrong information centre shall convey expeditiously to correct information centre.
3. Each Party shall take reasonable measures and within its power to ensure that there is at least an Information Centre, within its territory, able to answer all questions and requests from the Party and other interested persons and to provide relevant documents or information which may be obtained such documentation relating to:
a) Any standard or conformity assessment procedure adopted or proposed by non-governmental standardizing bodies in its territory; and
b) The membership and participation in bodies standardisation and conformity assessment systems international and regional non-governmental bodies in its territory.
4. Each Party shall ensure that the other party or by interested persons in accordance with the provisions of this chapter, upon request, copies of the documents referred to in paragraph 1, they shall provide the same price that applies to nationals, except the actual cost of shipment.
Article 14-10. Limitations on the Provision of Information
In addition to the provisions of article 21-03, nothing in this chapter shall be construed as requiring a party to furnish any confidential information the disclosure of which would prejudice legitimate commercial interests of a company.
Article 14-11. Metrology Patterns
For the purpose of avoiding the patterns metrological each party constitute unnecessary barriers to trade, the parties will make compatible, to the greatest extent possible, based on existing international standards.
Article 14-12. Health Protection
1. Medicines, equipment and medical equipment farmoquímicos products and other inputs for human, animal and plant health; food; products and toxic substances; products, materials, radioactive sources and equipment; emitting ionizing radiation sources and equipment subject to registration in the territory of a Party, shall, where appropriate, registered or evaluated, recognized by the competent authority of that Party under a single national system federal or central mandatory.
2. Certificates of conformity assessment from the goods referred to in paragraph 1 shall be accepted only if they have been issued by government agencies or non-governmental conformity assessment of each party.
3. The Parties shall establish a system of mutual technical cooperation to work on the basis of the following work program:
a) Identifying specific needs relating to:
i) The implementation of good manufacturing practices in the development and adoption of medicinal products for human use, animal or plant;
ii) The implementation of GLP systems analysis and assessment procedures in relevant international standards and guides; and
iii) The development of systems and identification of common nomenclature for auxiliary products to health and medical equipment;
b) Harmonization of requirements on labelling and the strengthening of the surveillance systems of standardization and related to labelling;
c) Training programmes and training, including the organization of a common system of training, continuing education, training and evaluation of official health inspectors; and
d) Development of an accreditation system for mutual units of verification and testing laboratories;
e) Updating of legal and regulatory frameworks;
f) Strengthening formal communication systems to monitor and regulate the exchange of products relating to human, animal or plant health.
4. For the purpose of carrying out activities proposed in paragraph 3, the Committee of measures related to established standardization under paragraphs 5 and 6 of article 14, a technical subcommittee on follow-up and organisation of such activities, to guide and make recommendations to the parties upon request.
Article 14-13. Risk Assessment
1. Pursuant to paragraphs 3 and 4 of Article 14-04, each Party may carry out risk assessments within its territory, as deemed appropriate. in so doing they shall take into account the risk assessment methods developed by international organizations and that their technical regulations and standards based on an assessment of risk to human health and safety, animal or plant and the environment.
2. In conducting a risk assessment, who carry out the Party shall take into consideration all relevant scientific evidence, technical information available, the intended end-use, processes or methods of production, operation, sampling, inspection, quality or evidence, or environmental conditions.
3. Once established a level of protection that it considers appropriate, when a Party in accordance with paragraph 3 of Article 14-04, an assessment of risk, avoid distinctions between similar goods or services in the level of protection that it considers appropriate, if such distinctions:
a) Have the effect of arbitrary or unjustifiable discrimination against goods or services of the other party;
b) Constitute a disguised restriction on trade between the parties; or
c) Discriminate between similar goods or services for the same use under the same conditions that pose the same level of risk and provide similar benefits.
4. Where a Party conducting a risk assessment concluded that scientific evidence or other information is insufficient to complete the evaluation, that Party may take a provisional measure on the basis of available relevant information. once it has submitted the information sufficient to complete the assessment of risk, the Party shall conclude as soon as possible the assessment, review and, where appropriate, reconsideration of the measure in the light of that assessment.
Article 14-14. Environmental Protection and Management of Chemicals and Hazardous Wastes
1. For the care and protection of the environment, each Party shall, subject to its laws, provisions, guides or recommendations of the United Nations Organisation and the relevant international agreements to which both parties are party.
2. Each Party shall regulate and monitor the introduction, production and marketing of pharmaceutical products, toxic agro-chemicals and any other dangerous substances of human, animal or plant health or the environment, in accordance with its laws and the provisions of this Treaty.
3. Each Party, in accordance with its laws, regulate the introduction, acceptance, storage, transport and transit through its territory of hazardous waste, radioactive or other internal or external, by their nature, constitute a danger to the health of its population, flora, fauna or environment.
Article 14-15. Labelling
1. The labelling requirements of goods and services are subject to the provisions of this chapter.
2. Each Party shall apply its relevant labelling requirements under this chapter.
3. The Parties shall develop common labelling requirements. the proposals made by each Party shall be evaluated by the Sub-Committee on measures related to standardization in packaging and labelling and packaging, in accordance with paragraph 5 of article 14.
4. The Sub-Committee measures relating to standardization in packaging and labelling and packaging may work and make recommendations on:
a) The establishment of a common system of symbols and pictograms to the Parties;
b) Definitions and terminology;
c) Submission of information, including language, measurement systems, ingredients and sizes; or
d) Other matters.
Article 14-16. Committee on Standards-Related Measures
1. The parties establish a Committee on measures related to standardization comprising representatives of each party.
2. The functions of the Committee include:
a) The Monitoring of Implementation and the administration of this chapter, including the progress of the Sub-Committees established pursuant to paragraph 5, the operation of the information centres established in accordance with paragraph 1 of Article 14-09 and updates to ISO / IEC guide 2: 1991;
b) Facilitating the process by which the parties make compatible their measures related to standardization and metrology;
c) To provide a forum for the parties to consult on issues relating to measures related to standardization and metrology;
d) Further to the relevant institutions to take into account developments on measures related to standardization governmental, non-governmental, regional and multilateral, including the Agreement on Technical Barriers to Trade;
e) Develop procedural mechanisms necessary to achieve mutual recognition of conformity assessment bodies; and
f) Report annually to the Commission on the implementation of this chapter.
3. The Committee shall:
a) It shall be composed of an equal number of representatives of relevant government institutions of each party. each Party shall establish procedures for the selection of their representatives;
b) Unless the parties agree otherwise, shall meet:
i) At least once a year; and
ii) At the request of any party;
c) It shall adopt its own rules of procedure; and
d) It shall take its decisions by consensus.
4. Each Party shall take the necessary steps to allow representatives of state governments, regional or local participation in the work of the Committee when it deems necessary.
5. The Committee shall:
a) The Sub-Committee of measures concerning the standardization of health;
b) The Sub-Committee of measures concerning the standardization of packaging and labelling and packaging;
c) The Sub-Committee of measures concerning the standardization of telecommunications; and
d) Any Sub-Committee that it considers appropriate to discuss, inter alia:
i) The identification and classification of goods and services subject to measures related to standardization;
ii) Technical regulations and standards of quality and identity;
iii) Programmes for the adoption of products and for monitoring after its sale;
iv) principles for accreditation or recognition of the facilities, testing and inspection agencies conformity assessment bodies;
v) The development and implementation of a uniform system for the information and classification of hazardous chemicals and the type of chemical hazard communication;
vi) programmes to ensure compliance with the rules in force, including the training and inspection by the Staff Regulations, analysis and verification of compliance;
vii) Promotion and implementation of good laboratory practice;