Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 86

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 86
---
 the European Commission Guidelines for Good Manufacturing Practice (“GMP”). These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical ingredients into the EU.
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
73

●   The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the EU notably under Directive 2001/83EC, as amended, and EU Member State laws.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation and Procedures Governing Approval of Medicinal Products in Japan
In order to market any medical product in Japan, a company must comply with numerous and varying regulatory requirements regarding quality, safety and efficacy in conducting clinical trials, obtaining marketing approval, distributing products and conducting product sales. Japan is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) and has pharmaceutical law and regulations that are similar in many respects to those of the U.S. and the EU. These requirements are embodied in the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (“Pharmaceuticals and Medical Devices Act”) and related cabinet orders, Ministerial ordinances, and guidelines. A Pharmaceutical company that manufactures or markets medical products in Japan is subject to the supervision of the MHLW, primarily under the Pharmaceuticals and Medical Devices Act. 
​
A clinical trial notification needs to be submitted to the PMDA in advance of clinical trial initiation in Japan. The marketing approval from MHLW needs to be obtained before the product can be marketed and sold in the Japanese market. Obtaining marketing approval requires the satisfactory completion of pharmaceutical development, preclinical studies and adequate and well-controlled clinical trials to establish the safety and efficacy of the medical product for each proposed indication. 
​
A company is required to obtain from the MHLW a marketing license of the appropriate class to conduct the business of marketing or providing medical products that are manufactured (or outsourced to a third party for manufacturing) or imported by such person. Also, to conduct the business of manufacturing medical products which will be marketed in Japan, a company is required to obtain from the MHLW a manufacturing license for each manufacturing site in Japan, and a manufacturing certification in the case of overseas manufacturing.
​
It is a requirement to obtain marketing approval from the MHLW for the marketing of