Equivalence Assessment Clause Samples
The Equivalence Assessment clause defines the process for determining whether a substitute product, service, or process is sufficiently similar to the original specified in the agreement. Typically, this clause outlines the criteria or standards that must be met for an alternative to be accepted, such as performance benchmarks, regulatory compliance, or functional capabilities. Its core practical function is to provide a clear framework for evaluating and approving alternatives, thereby reducing disputes and ensuring that any substitutions meet the agreed-upon requirements.
Equivalence Assessment. 1. ►M14 Prior to the start of the operational period, the Parties shall proceed to a joint assessment of the equivalence of the CABs that participated in the confidence-building activities. ◄ CABs will be determined to be equivalent provided they have demonstrated proficiency through the submission of a sufficient number of adequate reports. CABs may be determined to be equivalent with regard to the ability to perform any type of quality system or product evaluation covered by this Annex and with regard to any type of product covered by this Annex. The parties shall develop a list contained in Appendix 5 of CABs determined to be equivalent which shall contain a full explanation of the scope of the equivalency determination, including any appropriate limitations, with regard to performing any type of quality system or product evaluation.
2. The Parties shall allow CABs not listed for participation in the MRA, or listed for participation only as to certain types of evaluations, to apply for participation in this MRA once the necessary measures have been taken or sufficient experience has been gained, in accordance with Article 16.
3. Decisions concerning the equivalence of CABs must be agreed to by both Parties.
Equivalence Assessment. (a) The criteria to be used by the par- ties to assess equivalence are listed in appendix D of this subpart. Informa- tion pertaining to the criteria under European Community (EC) competence will be provided by the EC.
(b) The authorities of the parties will establish and communicate to each other their draft programs for assess- ing the equivalence of the respective regulatory systems in terms of quality assurance of the products and con- sumer protection. These programs will be carried out, as deemed necessary by the regulatory authorities, for post- and preapproval inspections and for various product classes or processes.
(c) The equivalence assessment shall include information exchanges (includ- ing inspection reports), joint training, and joint inspections for the purpose of assessing regulatory systems and the authorities’ capabilities. In conducting the equivalence assessment, the parties will ensure that efforts are made to save resources.
(d) Equivalence assessment for au- thorities added to appendix B of this subpart after the effective date de- scribed in § 26.80(a) will be conducted as
Equivalence Assessment. 1. The criteria to be used by the Parties to assess equivalence are listed in Appendix 4. Information pertaining to the criteria under Community competence will be provided by the Community.
2. The authorities of the parties will establish and communicate to each other their draft programmes for assessing the equivalence of the respective regulatory systems in terms of quality assurance of the products and consumer protection. These programmes will be carried out, as deemed necessary by the authorities, for post- and pre-approval inspections and for various product classes or processes.
3. The equivalence assessment shall include information exchanges (including inspection reports), joint training, and joint inspections for the purpose of assessing regulatory systems and the authorities’ capabilities. In conducting the equivalence assessment, the Parties will ensure that efforts are made to save resources.
4. Equivalence assessment for authorities added to Appendix 2 after the effective date of this agreement will be conducted as described in this Annex, as soon as practicable.
Equivalence Assessment. 1. The criteria to be used by the Parties to assess equivalence are listed in Appendix