Regulatory Approval definition

Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

Regulatory Approval means, with respect to the Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization that is required by the applicable Regulatory Authority to market and sell the Product in such country or jurisdiction.

Regulatory Approval means all approvals, product or establishment licenses, registrations or authorizations of any Regulatory Agency necessary for the manufacture, use, storage, import, export, transport, offer for sale, or sale of the Product.

Examples of Regulatory Approval in a sentence

• Regulatory Approval The applicant shall be responsible for obtaining the statutory clearances/approval including transmission licensee (if required) for carrying out the works requiring connection to the ISTS.

• Each of the Key Regulatory Approvals (including for certainty, the Stock Exchange Approval) has been made, given or obtained to the satisfaction of each of the Parties, acting reasonably, and each such Key Regulatory Approval is in force and has not been modified or rescinded.

• Subject to any restrictions in the Quality Agreement, each party may communicate with any Regulatory Authority responsible for granting Regulatory Approval for the Product (or in Patheon’s case the Manufacture of Products) and any other relevant Authority regarding the Product (or in Patheon’s case the Manufacture of Products) if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of the Authority or Applicable Laws.

More Definitions of Regulatory Approval

Regulatory Approval means any and all approvals (including price and reimbursement approvals, if required), licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a Product in such jurisdiction.

Regulatory Approval means any and all approvals, with respect to any jurisdiction, or authorizations (other than Price Approvals) of a Regulatory Authority, that are necessary for the commercial manufacture, distribution, use, marketing or sale of a pharmaceutical product in such jurisdiction.

Regulatory Approval means any and all approvals (including pricing and reimbursement approvals), licenses, registrations, or authorizations of any Regulatory Authority necessary to Exploit the Product in any country in the Territory, including any (a) approval of a Product, Marketing Authorization and supplements and amendments thereto; (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto); (c) labelling approval; and (d) technical, medical, and scientific licenses.

Regulatory Approval means, with respect to a product in a country, the approval of the applicable Regulatory Authority necessary for the marketing and sale of such product in such country.

Regulatory Approval means any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the manufacture, distribution, use, sale, and marketing of a Licensed Product for human therapeutic or prophylactic use in a regulatory jurisdiction.

Regulatory Approval means with respect to a country, extra-national territory, province, state, or other regulatory jurisdiction, any and all approvals, licenses, registrations or authorizations of any Regulatory Authority necessary in order to commercially distribute, sell, manufacture, import, export or market a product in such country, state, province, or some or all of such extra-national territory or regulatory jurisdiction, but which shall exclude any pricing and reimbursement approvals.

Regulatory Approval means the acceptance for filing, if required, of the transactions contemplated by this Agreement by the Regulatory Authorities;