Marketing Authorisation Application definition

Marketing Authorisation Application means an application for a Marketing Authorisation including but not limited to a New Drug Application or a Biologics License Application as required by the FDA or its foreign equivalents.
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Marketing Authorisation Application or “MAA” — an application filed by GW Pharma with a Regulatory Authority to obtain Marketing Authorisation for Product in the Territory, or any comparable application filed with the Regulatory Authority in or for a country or group of countries outside the Territory to obtain Marketing Authorisation for Product in or for that country or within that group of countries. “Manufacturing Authorisation” - any approval required from a Regulatory Authority to manufacture, assemble, test, store, distribute, import and wholesale deal the Product.
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Marketing Authorisation Application means the application form to be used for an application for a marketing authorisation of a medicinal product for human use (including all documents, data and other information relating thereto) submitted to either the (a) EMEA under the centralised procedure or (b) a Member State under either a national or mutual recognition procedure;
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Examples of Marketing Authorisation Application in a sentence

  • For further details see the Commission services note on the handling of Duplicate Marketing Authorisation Application, http://ec.europa.eu/health/files/latest_news/2011_09_upd.pdfThere are no corresponding provisions in Directive 2001/83/EC that apply to the mutual recognition and decentralised procedures.

  • Questions to consider should the City Council vote to move forward with a Comprehensive Study 1.

  • Risk Management PlanThe MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.

  • Risk Management PlanThe MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.

  • Risk Management plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.

  • The objective of this Best Practice Guide (BPG) is to emphasise the importance of taking care in the compilation of the dossier for a Marketing Authorisation Application (MAA), to minimise delays in validation, to avoid invalidation of submissions, to forestall questions from Member States (both RMS and CMS), and to enhance the efficiency of the regulatory process.This BPG provides a summary overview of points to consider at validation, together with a list of references as to where to find the advice.

  • On 3 April 2018, the Company announced that the EMA had validated for review the Marketing Authorisation Application (MAA) for Lynparza for use as a treatment of patients with deleterious or suspected deleterious BRCA-mutated, HER2-negative, metastatic breast cancer, who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.

  • No additional animal pharmacodynamic studies have therefore been conducted for the current Marketing Authorisation Application.

  • Such authorisation must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application;a Marketing Authorisation Application made to the EMA seeking authorisation of a new medicine.

  • In a report with CNN, Graham Maddocks, president and founder of the Ocean Support Foundation, states the lionfish invasion is probably the worst environmental disaster the Atlantic will ever face.


More Definitions of Marketing Authorisation Application

Marketing Authorisation Application means an application to obtain a Marketing Authorisation from a Regulatory Authority in a Country.
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Marketing Authorisation Application means an application for Marketing Authorisation in any country of the Territory;
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Related to Marketing Authorisation Application

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • 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 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.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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).

  • Safety Authorisation and “deemed Safety Authorisation” have the meanings given to “safety authorisation” and “deemed safety authorisation” by the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

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

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • FDA means the United States Food and Drug Administration.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

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

  • 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.

  • 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.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Pricing Approval means such mandatory governmental approval, agreement, determination or decision establishing prices for the Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

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

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.