Common use of Equivalence Assessment Clause in Contracts

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

Appears in 2 contracts

Sources: Mutual Recognition Agreement, Mutual Recognition Agreement

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 asas described in this subpart, as soon as practicable.

Appears in 1 contract

Sources: Mutual Recognition Agreement

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 asau-

Appears in 1 contract

Sources: Mutual Recognition Agreement