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.

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].

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.

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.

Marketing Authorization Holder means, with respect to a Product, the Party that holds Manufacturing and Marketing Approval in the Territory.

Marketing Authorization Holder shall have the meaning provided in Section 4.1(b).

Marketing Authorization Holder shall in all text refer to Oasmia or Hetero, as specifically agreed in writing by the Parties in a specific case;

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;

Marketing Authorization Holder has the meaning set forth in Section 6.2.1(b) (Other Regulatory Approvals).

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. 1.116 “Material Adverse Impact” means, with respect to any matter, that such matter (a) could have an adverse impact on the Development, Manufacture, Medical Affairs, or Commercialization of any Licensed Product outside of Japan (including any concern related to product integrity (including counterfeiting and diversion), quality, safety, toxicity, or side effects) or (b) is inconsistent with Licensor’s global regulatory strategy for any Licensed Product. 1.117 “Medical Affairs” means activities designed to ensure or improve appropriate medical use of, conduct medical education of, or further research regarding, a product, including by way of example: (a) activities of medical scientific liaisons who, among their other functions, may (i) conduct service-based medical activities including providing input and assistance with consultancy meetings, recommend investigators for Clinical Trials and provide input in the design of such trials and other research related activities and (ii) deliver non-promotional communications and conduct non-promotional activities including presenting new Clinical Trial and other scientific information; (b) grants to support continuing medical education, symposia, or Third Party research related to a product; (c) development, publication, and dissemination of publications relating to a product; (d) medical information services provided in response to scientific inquiries from healthcare providers (HCPs), communicated via sales representatives or received directly from an HCP by letter, phone call, or email; (e) the conduct of scientific advisory board meetings or other consultant programs; (f) the support of investigator-initiated trials, post-approval studies, and health economics and outcomes research; and (g) the implementation of risk, evaluation and mitigation strategies (REMS). Medical Affairs excludes any activities directed to Manufacturing, Development, or Commercialization. 1.118 “Medical Affairs Report” has the meaning set forth in Section 7.2 (Medical Affairs Reports). 1.119 “Negotiation Period” has the meaning set forth in Section 2.8.2. 1.120 “Net Sales” means the gross amount invoiced for sale or other disposition of the Licensed Products by Licensee, its Affiliates, Sublicensees, and any Affiliates of such Sublicensees (in each case, the “Inv...