Common use of Equivalence Assessment Clause in Contracts

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.