END OF TRANSITION PERIOD. Article 9
END OF TRANSITION PERIOD. Article 9 Equivalence determination Equivalence is established by having in place regulatory systems c overin g the criteria referre d to in Appendix 4, and a demonstrated pattern of c onsistent performance in acc ordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition perio d, with reference to any limitation in terms of inspection type (e.g. post-approval or pre-approval) or product classes or proc esses. The Parties will document insufficient evidence of equivalence, la ck of opportunity to assess equivalence or a determination of non-equivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence.
END OF TRANSITION PERIOD. No later than 18 months after the entry into force of this Agreement, the Joint Sectoral Group shall proceed to a joint evaluation of the experience gained. This evaluation will cover the adequacy of the Confidence Building Programme, the capabilities of Regulatory/Designating Authorities and the capabilities of the designated Conformity Assessment Bodies. Based on the results of the Confidence Building Programme, and by common agreement, the Parties may decide to extend the application of this Annex to include medical devices which were originally excluded from the Scope. Amendments to the Scope will be listed in Attachment 3. Recommendations to list CABs in Attachment 2 of this Annex shall be made by participating Designating/Regulatory Authorities, listed in Attachment 1, to the Joint Sectoral Group on the basis of the results of the Confidence Building Programme. Conformity Assessment Bodies that have been accepted by the Joint Sectoral Group will be listed in Attachment 2 with an indication of their specific conformity assessment expertise and the fields of medical device technologies for which they are recognized. Proposals to limit the recognition of capabilities of CABs should be based on objective evidence and documented. The Joint Sectoral Group may recommend that a CAB not be listed in Attachment 2, provided there is documented evidence demonstrating its lack of capabilities. Excluded CABs may apply for re- consideration of their status once the necessary corrective measures have been taken and confirmed. Where no agreement on any of the above matters has been reached in the Joint Sectoral Group, the matter will be referred to the Joint Committee under the Agreement. The Parties shall enter into the operational phase provided that there is representation of each Party's CABs in Attachment 2 . The agreement will also be re-examined at the end of the transitional period to take account of the regulatory evolution of each Party. Consideration shall be given to a single submission/evaluation/quality systems assessment which simultaneously satisfies the requirements of each jurisdiction.
END OF TRANSITION PERIOD. The parties agree that, effective immediately, the Transition Period is ended, Xx. Xxxxx’ employment as President and Chairman of BLS shall terminate, and Xx. Xxxxx shall cease to have any obligations to perform Transition Services.
END OF TRANSITION PERIOD. 10.1 Toll Rail must ensure that possession and control of any:
END OF TRANSITION PERIOD. Article 9 Equivalence determination Equivalence is established by having in place regulatory systems covering the criteria referred to in Appendix 4, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e.g. post-approval or pre-approval) or product classes or processes. The Parties will document insufficient evidence of equivalence, lack of opportunity to assess equivalence or a determination of non-equivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence.
