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 authorisation, consent, permit, permission, licence, certificates, registrations, approvals or other authorisations issued by any Authority and required under applicable Law to manufacture, market, promote, advertise, import, export or sell any product;

Marketing Authorisations means any:

Examples of Marketing Authorisations in a sentence

• 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.

• However, in the particular case of a cancellation motivated by the rejection of all applications for the Marketing Authorisations requested by BIOPHYTIS in Europe and the United States, with the most recent rejection occurring within six (6) months before the termination notice, the penalty under this paragraph (ii) will not be due.

• 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.

• 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.

• The PPA holder should consult the HPRA ‘Guide to Renewal of Marketing Authorisations – Human Medicines’ for general guidance on updating the SmPC, labels and package leaflet at renewal.

More Definitions of Marketing Authorisations

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.

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 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 and distribute a Designated Product in the United States, its territories and possessions or the consent or approval of any government or any governmental agency required to market and distribute a Designated Product outside of the United States.

Marketing Authorisations means the marketing authorisations issued or applications for Marketing Authorisations with respect to the Products and all supplements, amendments and revisions thereto including any pending Product Expansion Application;

Marketing Authorisations means the marketing authorisations listed in Schedule 15;