Marketing Authorization Holder definition

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].
Sample 1Sample 2Sample 3
Marketing Authorization Holder means a Party that possesses in its name, or is designated as the holder of, all Regulatory Approvals for the Licensed Product in the Territory and that is responsible for managing interactions with Regulatory Authorities in the Territory regarding the Licensed Product.
Sample 1Sample 2
Marketing Authorization Holder or “MAH” means the Person that owns the applicable Regulatory Approval.
Sample 1Sample 2Sample 3

Examples of Marketing Authorization Holder in a sentence

  • 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.

  • 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.

  • 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 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.
Sample 1Sample 2Sample 3
Marketing Authorization Holder means, with respect to a Product, the Party that holds Manufacturing and Marketing Approval in the Territory.
Sample 1
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;
Sample 1Sample 2Sample 3
Marketing Authorization Holder shall in all text refer to Oasmia or Hetero, as specifically agreed in writing by the Parties in a specific case;
Sample 1Sample 2
Marketing Authorization Holder has the meaning set forth in Section 6.2.1(b) (Other Regulatory Approvals).
Sample 1
Marketing Authorization Holder means the Person named on a Regulatory Approval as the Person authorized to market a pharmaceutical product under such Regulatory Approval.
Sample 1
Marketing Authorization Holder or “MAH” has the meaning set forth in Section 3.4.1.
Sample 1