Marketing Authorisation definition

Marketing Authorisation means, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

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 Authorisation the approval required from a Regulatory Authority to market and sell Product in a particular jurisdiction.

Examples of Marketing Authorisation in a sentence

• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT • Risk Management Plan (RMP)The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

• SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.

• Marketing Authorisation Holders are responsible for the accuracy and correctness of the content of the published RMP summaries.

• MEDICINAL PRODUCTS 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration)2.

More Definitions of Marketing Authorisation

Marketing Authorisation means an authorisation granted pursuant to the Med- icinal Products (Control of Placing on the Market) Regulations 2007 to 2014;

Marketing Authorisation means an authorisation for the sale and placing on the market or marketing of a Product within the Territory;

Marketing Authorisation means the authorisation granted, under section thirty-nine, for the placement of a medicine or allied substance on the market;

Marketing Authorisation means an authorisation or licence which is for the time being in force and which has been granted by—

Marketing Authorisation means the marketing authorisation (other than Conditional Marketing Authorisation), in respect of the Product granted by the European Commission, as amended or varied from time to time, that allows the Product to be placed on the market in the European Economic Area according to applicable Law;

Marketing Authorisation means authorisation to place a medicinal or healthcare product on the market in the European Union or any part of it whether centrally or nationally authorised, or any equivalent authorisation granted by any Regulatory Authority in any country or region outside the European Union; Marketing Authorisation Application or MAA means any application for a Marketing Authorisation; Major Markets means [***];

Marketing Authorisation means an authorisation which is for the time being in force and which has been granted by the Authority under the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007), or by the Commission under Regulation (EC) No. 726/20042and includes a marketing authorisation issued by the competent authority of an EEA State, other than the State, in accordance with Directive 2001/83/EC6;