Common use of The Scheme Clause in Contracts

The Scheme. 1. The Parties shall adopt a joint scheme for the regulation of the quality, safety, and efficacy or performance of therapeutic products, and in particular for: (a) the regulation of the manufacture, supply, import, export and promotion of therapeutic products; (b) the setting of standards in relation to the quality, safety, and efficacy or performance of therapeutic products and their manufacture, supply, import, export and promotion; (c) the post-market monitoring of therapeutic products; and (d) the enforcement of the Scheme’s requirements. 2. Where a Rule requires an Approval in relation to the manufacture, supply, import, export or promotion of a therapeutic product, each Party shall prohibit the manufacture, supply, import, export or promotion of the therapeutic product otherwise than under and in accordance with the required Approval. 3. Where a Rule prescribes the manner or circumstances in which a therapeutic product is not to be manufactured, supplied, imported, exported or promoted, each Party shall prohibit the manufacture, supply, import, export or promotion of the therapeutic product in that manner or those circumstances. 4. Where a Rule or Order prescribes requirements relating to the manufacture, supply, import, export or promotion of a therapeutic product, each Party shall prohibit such manufacture, supply, import, export or promotion unless it is carried out in accordance with the Rule or Order. 5. Each Party shall ensure the effective implementation, operation, maintenance and enforcement of the Scheme in accordance with the objectives of this Agreement and, subject to paragraph 4 of Article 11 and to Article 12, shall ensure that its joint nature is maintained. 6. The Parties shall conduct effective consultation together in relation to the legislation to be enacted by each Party to implement the Scheme, and in relation to any amendments to that legislation, with a view to ensuring that it is consistent with and gives effect to the objectives of this Agreement. 7. Each Party shall ensure that its legislation implementing the Scheme is not amended or repealed in a manner that is inconsistent with this Agreement, or would prejudice the joint nature of the Scheme or its effectiveness. 8. A Party shall not: (a) introduce Government legislation giving effect to paragraphs 4 or 5 of Article 5; or (b) introduce Government amendments to the legislation giving effect to paragraphs 4 or 5 of Article 5; without the written consent of the other Party, which may be withheld only if the other Party: (c) is of the view that the legislation is inconsistent with the requirements of paragraphs 4 or 5 of Article 5; and (d) outlines the nature of its concerns in a diplomatic note. 9. Each Party shall use its best endeavours to reach agreement with the other Party in relation to any other amendments to the legislation that gives effect to Article 5, including, where relevant, reflecting the position of the other Party in any papers for the Government of that Party. 10. The Parties shall cooperate closely in relation to mutual recognition or other arrangements with third countries that may affect the regulation of therapeutic products within their respective territories, with a view to securing outcomes consistent with the Scheme.