Marketing Authorisation definition

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.

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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 marketing authorisation in respect of the Goods granted by the Licensing Authority as amended or varied by the Licensing Authority from time to time;

Examples of Marketing Authorisation in a sentence

• Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted.

• DESITIN shall keep ZOGENIX informed, in writing, of the status of its applications for Marketing Authorisations on a regular basis, and in any event no less frequently than once every three months, and shall immediately notify ZOGENIX in writing of any substantial change in the status of any Marketing Authorisation or any substantive questions received from any Regulatory Authority in respect of such Marketing Authorisations.

• In particular DESITIN shall take all necessary steps to obtain Marketing Authorisation and prepare the Launch of the Product in Germany.

• In exploring in which other countries of the Territory the obtaining of Marketing Authorisation and the subsequent marketing of the Product, whether by DESITIN or DESITIN’s Affiliates or by local distribution partners, is likely to be profitable and commercially feasible, DESITIN will focus on France, Italy, Spain, the United Kingdom, Denmark, Sweden and Finland.

• Where Sobi develops educational materials in languages other than the languages for which TiGenix has provided/approved the materials, it shall be responsible for the correct translation and, if applicable outside of the scope of TiGenix’ current Marketing Authorisation, for obtaining approval by the relevant Regulatory Authority of the materials in such other languages.

More Definitions of Marketing Authorisation

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

Marketing Authorisation means any approval required from the relevant Regulatory Authority or Authorities to distribute, promote, market and sell Licensed Products in the Elidel Territory or Xerese Territory, as applicable.

Marketing Authorisation means a marketing authorisation granted pursuant to the Control of Placing on the Market Regulations;

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;