Marketing Authorisations definition

Marketing Authorisations means, in respect of a Seller, the marketing authorisations issued or applications for marketing authorisations with respect to its Products, and all supplements, amendments and revisions thereto;

Marketing Authorisations means any:

Marketing Authorisations means the consent or approval of the FDA and any applicable comparable state agencies required to market or distribute the FINISHED PRODUCT in the TERRITORY. ARTICLE II.

Examples of Marketing Authorisations in a sentence

• An attempt has been made to list all appropriate production steps and controls as required by the various Marketing Authorisations and the relevant monographs of the Ph. Eur.

• ALVOTECH is engaged in the development of pharmaceutical products, and pursuant to development works and studies, is holding comprehensive, valuable, proprietary information and data concerning a pharmaceutical product with the API [***] which enable ALVOTECH and/or STADA to successfully apply for Marketing Authorisations with local Health Authorities in the Territory in order to sell the corresponding pharmaceutical product.

• Paediatric Use Marketing Authorisations (PUMAs) maybe granted through any appropriate national licensing route and are eligible for 8+2 years data exclusivity/market protection.

• Those without a current UK presence would have until the end of 2020 at the latest to establish a UK presence but would nevertheless be required to make arrangements for providing the MHRA with access to the relevant safety data related to UK Marketing Authorisations (MAs) at any time, and comply with UK inspection requirements, during that interim period.

• In addition, a record of any medication supplied through this scheme should be documented in the Patients Medication Record (PMR) on the pharmacy IT system.All supplies must be labelled in line with the labelling requirements for a dispensed medicine as stated within Schedule 5 of The Medicines (Marketing Authorisations Etc) Regulations 1994, No 3144 as amended.

More Definitions of Marketing Authorisations

Marketing Authorisations means the marketing authorisations issued or applications for Marketing Authorisations with respect to the Products and all supplements, amendments and revisions thereto;

Marketing Authorisations means the authorisations for the sale and marketing of the Products in the Territory granted by a Medicinal Products Regulatory Authority as may be varied from time to time.

Marketing Authorisations means the marketing authorisations issued or applications for marketing authorisations with respect to the Products and all supplements, amendments and revisions thereto;

Marketing Authorisations means the marketing authorisations listed in Schedule 15;

Marketing Authorisations shall have the meaning defined in the License and Distribution Agreement.

Marketing Authorisations means the consent or approval of the FDA and any applicable comparable state agencies required to market or distribute the FINISHED PRODUCT in the TERRITORY. Q. ***** ***** *** ****** ****** ******* **** *********** ******* R. "NDA" means the new drug application required to manufacture, market and sell the PRODUCT and the FINISHED PRODUCT in the TERRITORY. References in this AGREEMENT to Articles Clauses and Appendices are, unless otherwise stated, to Articles and Clauses of and Appendices to this AGREEMENT. In this AGREEMENT the singular includes the plural and vice versa, the masculine includes the feminine and vice versa and references to natural persons include corporate bodies, partnership and unincorporated associations and vice versa. The headings in this AGREEMENT are for ease of reference only and shall not affect its construction or interpretation. ARTICLE II.

Marketing Authorisations means any license or approval of any AGENCY necessary for the MANUFACTURE, PACKAGING, export and/or COMMERCIALISATION of the PRODUCTS in the TERRITORY;