Risk of Pharmaceutical Regulatory Violations and License and Permit Revocation
First written in FY2017. 1 of 2 entries say "Restated". Latest entry: FY2022.
The whole theme swung hardest in 2021: 2 of 14 companies on the "Worse" side.
16 other companies' latest entry also says "Restated".
- FY2022RestatedAnnual report
「No circumstances giving rise to the cancellation of the relevant licences and approvals have occurred as of the present time. However, if the licences and approvals are cancelled due to violations of laws and regulations or for other reasons, the Group may be required to recall regulated products, or discontinue their manufacture and sale. This could have a material impact on the Group's business activities.」
While stating that no grounds for cancellation of licences and approvals have arisen as of the present time, the Company continues to disclose the risk of business impacts from violations of laws and regulations and regulatory amendments. - FY2017First statedAnnual report
「If the relevant licences and approvals are cancelled due to violations of laws and regulations or for other reasons, the Group may be required to recall regulated products, or discontinue their manufacture and sale. This could have a material impact on the Group's business activities.」
The impact on licences and approvals and business activities of violations of the Pharmaceuticals and Medical Devices Act and other laws and regulations, as well as amendments to related laws and regulations, is identified as a risk.