Relevant Regulatory Authority definition

Relevant Regulatory Authority means (i) in relation to a particular country in the Territory, any applicable federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Products in that country, or (ii) WHO pre- qualification programme where such approval has been deemed adequate by the authority referred to in (i).

Relevant Regulatory Authority in relation to a country or region, means the governmental authority, whether federal, state, provincial, or municipal, regulating the use, importation, manufacture, marketing, sale or distribution of pharmaceutical substances and the grant of Marketing Authorisations in such country or region;

Relevant Regulatory Authority means the European Commission, the Dutch Authority for Consumers and Markets, and the Dutch Minister for Economic Affairs;

Examples of Relevant Regulatory Authority in a sentence

• To the extent either Party receives written or material oral communication from any Relevant Regulatory Authority relating to the Licensed Product in the Territory, the party receiving such communication shall notify the other parties and provide a copy of any written communication as soon as reasonably practicable.

• Each Party will immediately notify the other Party of any material events relating to the Development of the Licensed Product in the Territory, including, without limitation, any material comments or concerns raised by any Relevant Regulatory Authority.

• Licensee shall inform Cellegy on at least a semi-annual basis (and more frequently if Cellegy so reasonably requests) about the progress of such registration work, and will promptly provide Cellegy with a copy of all presentations and documents submitted by Licensee to any Relevant Regulatory Authority with respect to the Licensed Product.

• Each Party agrees to provide to the other Party a copy of (i) any documents or reports relating to the Licensed Product that are filed with any Relevant Regulatory Authority in the Territory under this Agreement, including any Approval applications; and (ii) all data, database information and safety reports from clinical trials conducted by or on behalf of Licensee.

• If, within *** of the receipt of notice under clause 11.1, the parties are unable to agree on the need to undertake a recall (including after HPPI discusses the issue with the Relevant Regulatory Authority), then either party may direct that the Product be recalled, with or without the agreement of the other party, if it reasonably determines that such recall is necessary to protect the public health or is necessary to ensure compliance with applicable laws, rules and regulations.

More Definitions of Relevant Regulatory Authority

Relevant Regulatory Authority means, in relation to the provision of Investment Services and Banking and Custody Services by JPMorgan Chase Bank, N.A., acting through its Hong Kong branch, the HKMA and the SFC; by JPMorgan Chase Bank, N.A., acting through its Singapore branch, the MAS and the relevant regulatory authorities in the U.S. regulating X.X. Xxxxxx.

Relevant Regulatory Authority shall have the meaning set forth in the Supply and License Agreement.

Relevant Regulatory Authority means the European Commission, the CMA, the FCA or the Secretary of State (as the case may be);

Relevant Regulatory Authority means the insurance regulatory authority of Ceding Company’s state of domicile.

Relevant Regulatory Authority means the European Commission or the Office of Fair Trading or such other regulator who may have concurrent jurisdiction with the Office of Fair Trading under the Competition Xxx 0000.

Relevant Regulatory Authority means, collectively, the European Commission, EMA, MHRA and any other and any other national, supranational, regional, provincial or local governmental or regulatory authority, agency, department, bureau, commission, council or other government entity having jurisdiction over the manufacture, importation, promotion, marketing, distribution or sale of the Products in the Territory.

Relevant Regulatory Authority has the meaning given to such term in the Sublicence;