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].

Marketing Authorization Holder or “MAH” means the Person that owns the applicable Regulatory Approval.

Examples of Marketing Authorization Holder in a sentence

As set forth in Section 5.1(b), the Parties shall cooperate to be ready to transfer and assign these EMA Regulatory Filings to Licensee and Exelixis shall notify the EMA promptly after the Effective Date that Licensee shall be the Marketing Authorization Holder as from the date of the transfer of the MAA.
Nitec AG, through Nitec Germany, has applied for the MARKETING AUTHORIZATION for the PRODUCT in Germany with the competent authority thereby becoming a Marketing Authorization Holder (“MAH”), as defined in § 4 subp.
KHK will be the sole Marketing Authorization Holder in the Territory.
The purpose of the regulatory agreement is to describe the co-operation between medac as the responsible owner of the Product and ERYtech Pharma as the responsible sponsor and future Marketing Authorization Holder for GRASPA®.
Nitec AG, through Nitec Germany, has applied for the MARKETING AUTHORIZATION for the PRODUCT in Austria with the competent authority thereby becoming a Marketing Authorization Holder (“MAH”), as defined in § 2 subp.

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.

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

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

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

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

Marketing Authorization Holder means a person who resides in Japan and is granted a license for