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May 15, 2025 · Marketing Authorization Transfer Considerations. When a Marketing Authorization is transferred, the new MAH receives both rights and duties.
This document specifies the Transfer of Marketing Authorization in Japan. Transfer of Marketing Approval and how to fill in the form.
May 12, 2025 · Conclusion Successfully launching and maintaining a pharmaceutical product in the Japanese market requires a comprehensive understanding of the distinct yet …
Aug 11, 2023 · In Japan, only a local entity qualified as a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH) may import and sell medical products to …
Oct 29, 2024 · This article answers some of the key legal and practical questions surrounding the grant of marketing authorisation for pharmaceuticals and medical devices in Japan.
Dec 5, 2022 · The Marketing Authorization Holder (MAH) makes an application for approval of a medical device on behalf of the foreign manufacturer. The MAH is a Japan-based company or …
For the classification of medical devices in Japan, please refer to “Regulations and Approval/Certification of Medical Devices” page for details. These procedures should be …
May 15, 2025 · Dio Inoue Partner Tokyo Atsumi & Sakai In Japan’s highly regulated pharmaceutical market, the transfer of marketing approval for medicines is a critical process …
This document offers a detailed overview of the marketing authorization process in Japan, the regulatory agencies involved, and the latest trends in drug approval.
Understanding the MAH Japan System In Japan, the Marketing Authorization Holder (MAH) is central in the pharmaceutical and medical device sectors. An MAH is tasked with securing …
Mar 6, 2025 · American pharmaceuticals company acquired the global right of inhaled drug product and needed to transfer the license of the product from the current marketing …
Our Edge in Marketing Authorization Holder Services Providing services for the manufacturing and sales of products in Japan CMIC is the only CRO in Japan that can offer Marketing …
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