Marketing Authorization Holder definition

Marketing Authorization Holder means a person who possesses all Regulatory Approvals for any particular indication in the Territory in such person’s name and who will manage all interactions with Regulatory Authorities regarding such Regulatory Approval.
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Marketing Authorization Holder means a person who resides in Japan and is granted a license for marketing from a prefectural government [PMD Act 23-2.1].
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Marketing Authorization Holder means a person / organization to which a legal document is issued by the competent drug regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality. The Marketing Authorization Holder ideally should be a pharmacist or a pharmaceutical company authorized to practise in Sierra Leone.
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Examples of Marketing Authorization Holder in a sentence

  • For drugs, the Local Representative or the Marketing Authorization Holder shall permanently and continuously have at his disposal an appropriately Qualified Person Responsible for Pharmacovigilance resident in Ghana.

  • In such a situation, the Local Representative or Marketing Authorization Holder shall provide all the available details making appropriate references to the information provided by the initial reporter, in order to aid identification of the duplicate.

  • When the Local Representative or Marketing Authorization Holder is involved in relationships including those that are contractual, arrangements for meeting safety monitoring obligations shall be clearly specified in writing to the Food and Drugs Authority.

  • The Local Representative or Marketing Authorization Holder is required to submit the name or initials, address and telephone number and qualification of the initial reporter on the adverse drug reaction report form.

  • The FDA shall acknowledge receipt of the report and preliminary evaluation comments communicated to the Local Representative or the Marketing Authorization Holder within 28 days of receipt of the report.


More Definitions of Marketing Authorization Holder

Marketing Authorization Holder or “MAH” means the Person that owns the applicable Regulatory Approval.
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Marketing Authorization Holder means a legal entity to whom a medicinal product marketing authorization has been granted and which is legally responsible for the safety, efficacy, and quality of the medicinal product;
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Marketing Authorization Holder means the party holding the Marketing Authorization.
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Marketing Authorization Holder shall have the meaning provided in Section 4.1(b).
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Marketing Authorization Holder shall in all text refer to Oasmia or Hetero, as specifically agreed in writing by the Parties in a specific case;
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Marketing Authorization Holder has the meaning set forth in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals).
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Marketing Authorization Holder means a local, qualified entity that holds a license from a Regulatory Authority to market a pharmaceutical product in the Territory pursuant to the requirements, obligations, and guidelines of the MHLW, PMDA, and any other applicable Regulatory Authority. 1.48 “MHLW” means the Japanese Ministry of Health, Labour and Welfare, or any successor agency thereto. 1.49 “Net Sales” means, with respect to the Royalty Payments, the aggregate gross invoiced sales prices from sales of all units of the Product sold in the Territory by a member of Recordati’s Group or any Sublicensee of Recordati to Third Parties after deducting, if not previously deducted, from the amount invoiced or received: (a) [***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; (f) [***]; (g) [***]; and (h) [***]. Such amounts shall be determined from the books and records of Recordati that are maintained in accordance with the applicable Accounting Standards. In the case of any sale or other disposal for value, such as barter or counter-trade, of the Product in the Territory, other than in an arm’s length transaction exclusively for cash, Net Sales shall be calculated as above on the value of the non-cash consideration received in relation to the 6 ACTIVE/99458941.1
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