Application of Regulatory Controls Sample Clauses

Application of Regulatory Controls. 1. Each Party shall ensure that for a measure it applies to ensure the safety, effectiveness, or quality of cosmetic products, including marketing authorizations, notification procedures, and elements of either, products imported from the territory of another Party be accorded treatment no less favorable than that accorded to like products of national origin and to like products originating in any other country, in a comparable situation. 2. In developing a regulatory requirement for a cosmetic product, each Party shall consider its available resources and technical capacity in order to minimize the likelihood of implementing requirements that could: (a) inhibit the efficacy of procedures for ensuring the safety, effectiveness, or quality of cosmetic products; or (b) lead to substantial delays for cosmetic products becoming available in that Party’s market. 3. Each Party shall apply a risk-based approach to regulating the safety of cosmetic products for human health, taking into account relevant scientific factors. In applying this approach, each Party shall take into account that cosmetic products generally present a lower potential risk to human health or safety than medical devices or pharmaceutical products. Accordingly, no Party shall require: (a) a marketing authorization for a cosmetic product, unless a Party identifies a human health or safety concern, and a less trade-restrictive alternative, such as a notification or post-market surveillance, is not reasonably available to effectively address the risks at issue; (b) re-testing or re-evaluating of a cosmetic product that differs only with respect to shade extensions or fragrance variants, unless conducted for human health or safety purposes; (c) a cosmetic product to be labeled with a notification number; (d) a cosmetic product to receive a marketing authorization from a regulatory authority in the country of manufacture, as a condition for being placed in its market;4 or
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Application of Regulatory Controls. 1. Each Party shall ensure that for a measure it applies to ensure the safety, effectiveness, or quality of pharmaceutical products, including marketing authorizations, notification procedures, and elements of either, products imported from the territory of another Party be accorded treatment no less favorable than that accorded to like products of national origin and to like products originating in any other country, in a comparable situation. 2. When developing a regulatory requirement for a pharmaceutical product, each Party shall consider its available resources and technical capacity in order to minimize the likelihood of implementing requirements that could: (a) inhibit the efficacy of procedures for ensuring the safety, effectiveness, or quality of pharmaceutical products; or (b) lead to substantial delays for pharmaceutical products becoming available in that Party’s market. 3. The Parties shall seek to improve their collaboration on pharmaceutical inspections. Accordingly, each Party shall, with respect to a good manufacturing practice surveillance inspection of a manufacturing facility for pharmaceutical products within the territory of another Party: (a) notify the other Party prior to conducting an inspection, unless there are reasonable grounds to believe that doing so could prejudice the effectiveness of the inspection; (b) if practicable, permit representatives of the other Party’s competent authority to observe the inspection; and (c) notify the other Party of its findings as soon as possible following the inspection and, if the findings will be publicly released, no later than a reasonable time before release. With respect to subparagraph (c), the inspecting Party is not required to notify the other Party of a finding that is subject to treatment as confidential information under the inspecting Party’s law. 4. Upon certification by the competent authority in the United States, the competent authorities of Canada and the United States shall establish mechanisms to permit the exchange of confidential information relevant to pharmaceutical inspections, including unredacted Good Manufacturing Practice inspection reports. 5. Upon certification by the competent authority in the United States, the competent authorities of Mexico and the United States shall establish mechanisms to permit the exchange of confidential information relevant to pharmaceutical inspections, including unredacted Good Manufacturing Practice inspection reports. 6. To facili...
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Related to Application of Regulatory Controls

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Compliance with U.S. Securities Laws; Regulatory Compliance Notwithstanding any provisions in this Receipt or the Deposit Agreement to the contrary, the withdrawal or delivery of Deposited Securities will not be suspended by the Company or the Depositary except as would be permitted by Instruction I.A.(1) of the General Instructions to the Form F-6 Registration Statement, as amended from time to time, under the Securities Act.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Absence of Regulatory Actions Since January 1, 2017, neither Purchaser nor any of its Subsidiaries has been a party to any cease and desist order, written agreement or memorandum of understanding with, or any commitment letter or similar undertaking to, or has been subject to any action, proceeding, order or directive by any Governmental Entity, or has adopted any board resolutions relating to such matters as are material to the business of Purchaser or its Subsidiaries at the request of any Governmental Entity, or has been advised by any Governmental Entity that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such action, proceeding, order, directive, written agreement, memorandum of understanding, commitment letter, board resolutions or similar undertaking. To the Knowledge of Purchaser, there are no material unresolved violations, criticisms or exceptions by any Governmental Entity with respect to any report or statement relating to any examinations of Purchaser or its Subsidiaries.

  • Application for approval 3.1. The application for approval of a vehicle type with regard to the AEBS shall be submitted by the vehicle manufacturer or by his authorised representative. 3.2. It shall be accompanied by the documents mentioned below in triplicate: 3.2.1. A description of the vehicle type with regard to the items mentioned in paragraph 2.4., together with a documentation package which gives access to the basic design of the AEBS and the means by which it is linked to other vehicle systems or by which it directly controls output variables. The numbers and/or symbols identifying the vehicle type shall be specified. 3.3. A vehicle representative of the vehicle type to be approved shall be submitted to the Technical Service conducting the approval tests.

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • Governing Law, Regulatory Authority, and Rules The validity, interpretation and enforcement of this Agreement and each of its provisions shall be governed by the laws of the state of New York, without regard to its conflicts of law principles. This Agreement is subject to all Applicable Laws and Regulations. Each Party expressly reserves the right to seek changes in, appeal, or otherwise contest any laws, orders, or regulations of a Governmental Authority.

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • Certification Regarding Prohibition of Boycotting Israel (Tex Gov. Code 2271)

  • Territorial application This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.

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