Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.
Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.
Supervisory Authority means an independent public authority which is established by an EU Member State pursuant to the GDPR.
MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.
Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.
European Commission means the authority within the European Union that has the legal authority to grant Regulatory Approvals in the European Union based on input received from the EMA or other competent Regulatory Authorities.
Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.
IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Competent Supervisory Authority means a supervisory authority which has jurisdiction in relation to the activities of a controller or processor under European data protection law in a particular Member State;
Board of appeals means the local board of appeals as created by local ordinance.
Board of Studies means the Board of Studies of the University;
UK Listing Authority means the Financial Services Authority in its capacity as competent authority under the Financial Services and Markets Xxx 0000.
European Community means the territory comprised by the Member States of the European Community as constituted from time to time;
Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.
Meeting Materials means the notice of meeting, the Circular and the form of proxy in respect of the Meeting which accompanies the Circular.
Government Apprenticeship Programme “ means training which is funded by the Government via the National Apprenticeship Service.
Preliminary Approval means the Court’s Order Granting Preliminary Approval of the Settlement.
Accepted Author Manuscripts An accepted author manuscript is the manuscript of an article that has been accepted for publication and which typically includes author- incorporated changes suggested during submission, peer review and editor-author communications. Published journal article (JPA): A published journal article (PJA) is the definitive final record of published research that appears or will appear in the journal and embodies all value-adding publishing activities including peer review co-ordination, copy-editing, formatting, (if relevant) pagination and online enrichment.
Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).
Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;
Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];
Minister for Mines means the Minister in the Government of the State for the time being responsible for the administration of the Mining Act;