Mutual Recognition Agreement Francais

Published on 11 April 2021 by in Uncategorized


In the absence of a written agreement between the parties, the obligations contained in the mutual recognition agreements have no effect and have no effect on the other party with respect to the acceptance of the results of the compliance assessment procedures by the third party by a party that is not a party to this agreement (one third party). The transitional regime is intended to provide a means by which the parties to this agreement can cooperate in the establishment of a system for the designation of compliance assessment bodies and to strengthen mutual confidence in the capabilities of these agencies. The purpose of this transitional regime is to establish that compliance assessment bodies meet the applicable criteria and that the equipment is approved by the exporting country`s compliance assessment bodies by the competent authority of the importing country. A description of mutual recognition obligations After receiving a full proposal, the EC agrees or opposes the Joint Committee within 60 days. The Joint Committee monitors and confirms the recognition of compliance assessment agencies by listing them in Section V of this sector annex. Ensure the development/existence and mutual understanding of the GMP compliance program of each party`s regulators. Elements of the GMP compliance program are used to determine the equivalence of relevant regulatory programs. The suspension remains in effect until the parties reach an agreement on the future status of the organization. This agreement includes three components covering a range of discrete products: unless this agreement is expressly provided for by a joint decision of the parties, this agreement does not apply to a Class II product in the United States or to a Class III product under either system. This agreement sets out the conditions under which each party accepts or recognizes the results of compliance assessment procedures submitted by the other party`s compliance assessment agencies or authorities in assessing compliance with the importing party`s requirements, as defined in the sectoral annexes, and provides for other related cooperation activities. The purpose of this mutual recognition is to ensure effective market access throughout the contracting parties` territory in assessing the compliance of all products covered by this agreement. In the event of obstacles to this access, consultations are carried out without delay.

In the absence of satisfactory results from these consultations, the party refusing market access may, within 90 days of holding that consultation, invoke its right to denounce the agreement in accordance with Article 21. For the purposes of this agreement, the points of contact of the alert system will be as follows: any proposal submitted during or at the end of the transition period to restrict the scope of recognition of a notified compliance assessment agency or to exclude it from the list of organizations designated in this sectoral annex is based on objective and documented criteria. Such an organization may request a re-examination as soon as the necessary corrective action has been taken. Where possible, the parties implement these measures before the end of the transitional period. NOTE that mutual recognition of compliance assessment activities is an important way to improve market access between parties; Given the respective commitments of the parties under bilateral, regional and multilateral agreements on the environment, health, safety and consumer protection. Mutual recognition of compliance programs requires a common exercise to determine the equivalence of compliance programs.

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