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

  • Marketing Authorization Holder: The company or legal entity in whose name the marketing authorization for a product has been granted and is responsible for all aspects of the product and compliance with the conditions of marketing authorization.

  • This is due to the occurrence of very deep groundwater volumes, whereas the groundwater volume in the upper 100 m is more limited.

  • 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.


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 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 shall have the meaning provided in Section 4.1(b).
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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 or “MAH” means the holder of the relevant MAA(s) or issued marketing authorization(s) with respect to a Licensed Product and all supplements, amendments, and revisions thereto. 1.137 “Material Adverse Impact” means, with respect to any matter, that such matter (a) could have a material adverse impact on the Development, Manufacture, Medical Affairs, or Commercialization of any Licensed Product (including any concern related to product integrity (including counterfeiting and diversion), quality, safety, toxicity, or side effects) or (b) is materially inconsistent with Licensor’s global regulatory strategy for any Licensed Product. 1.138 “Medical Affairs” means activities designed to ensure or improve appropriate medical use of, conduct medical education of, or further research regarding, a product, including
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