Application for Marketing Approval definition

Application for Marketing Approval means any act of submission of materials, information, data, documents, etc. to a Regulatory Authority required to obtain a Marketing Approval for the Product in the Territory, such as NDA in the US and MAA in the EU. “Initial Application for Marketing Approval” means the initial application submitted to a Regulatory Authority to obtain a Marketing Approval for the Product in the Territory.
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Application for Marketing Approval means a new drug application or a biologics license application or any functional equivalent of such an application seeking approval to market a pharmaceutical product in the United States or elsewhere.
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Examples of Application for Marketing Approval in a sentence

  • Refer to PFSB/ELD ( Iyakushin) Notification No. 0213001 of the Director of Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau dated February 13, 2003, “Basic Principles of Biological Safety Evaluation Required for Application for Approval to Manufacture (Import) Medical Devices” and separately notified “Basic Principles of Biological Tests Required for Application for Marketing Approval of Dental Materials,” and submit the necessary data.

  • Step Two: Submit Application for Marketing Approval Once the licence has been obtained to either import or locally produce a sample of the new drug, a full marketing approval application must be compiled to accompany the samples of the new drug.

  • ALVOTECH Date: October 17, 2022 By: /s/ Tanya ZharovName: Tanya ZharovTitle: Deputy Chief Executive OfficerExhibit 99.1 Alvotech’s Partner Submits Application for Marketing Approval of First Biosimilar Candidate in Japan REYKJAVIK, ICELAND (October 17, 2022) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner Fuji Pharma Co., Ltd.

  • Cephalon Files Application for Marketing Approval of New Modafinil Formulation for the Treatment of Children and Ado-lescents With Attention-Deficit/Hyperactivity Disorder.

Related to Application for Marketing Approval

  • 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.

  • 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.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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.

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • 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.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • 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.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Major Market Country means one or more of the following: Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, and United States of America.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • 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;

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Development approval means any written authorization from a

  • Licensed Territory means worldwide.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.