Marketing Authorisation Application definition

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 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 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.

  • However if the study is considered to be pivotal to the application, there is a possibility that a study audit will be required by some regulatory receiving authorities at the time an investigational medicinal product dossier (IMPD) is received or at the time the Marketing Authorisation Application (MAA) is reviewed.

  • Under the terms of the agreement, the Company received an upfront payment of USD 55 million and is eligible to receive up to USD 382.5 million in regulatory and net sales-based milestones, of which USD 50 million in license revenue was recognized in December 2022 upon approval of a Marketing Authorisation Application by the European Commission for ZYNLONTA in third-line DLBCL and received in the first quarter of 2023.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • In April 2018, the Company submitted a request for re-examination of the negative opinion adopted by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) on the Company’s European Marketing Authorisation Application (“MAA”) for abaloparatide for subcutaneous administration (“abaloparatide-SC”) and in July 2018, following a re-examination procedure, the CHMP maintained its negative opinion.

  • In this Marketing Authorisation Application (MAA), Takeda seeks registration of alogliptin/metformin at a dose of alogliptin 6.25 mg or 12.5 mg in combination with metformin 850 mg or 1000 mg for twice daily (BID) dosing in adults with T2DM.The product is manufactured as immediate-release, oblong, biconvex, film-coated tablets for twice daily oral administration.Six dosage strengths of alogliptin/metformin (A6.25+M500, A6.25+M850, A6.25+M1000, A12.5+M500, A12.5+M850, and A12.5+M1000) were developed.


More Definitions of Marketing Authorisation Application

Marketing Authorisation Application means any application for a Marketing Authorisation.
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Marketing Authorisation Application means an application to the appropriate Regulatory Authority for Marketing Authorisation for the Product in any particular jurisdiction and all amendments and supplements thereto.
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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 for Regulatory Approval in a country, territory or possession.

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

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

  • 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 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.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • 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.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 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 or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.