Risk of Business Suspension Due to Violations of Pharmaceutical Laws and Regulations and Cancellation of Licenses and Permits
First written in FY2017. 7 of 8 entries say "Restated". Latest entry: FY2023-Q3.
The whole theme swung hardest in 2021: 2 of 14 companies on the "Worse" side.
16 other companies' latest entry also says "Restated".
- FY2023-Q3RestatedAnnual report
「During the cumulative third-quarter period, there were no new business risks and no material changes in the business risks described in the annual securities report for the preceding fiscal year.」
The company has disclosed that there have been no material changes in the risk of business suspension due to violations of pharmaceutical regulations or revocation of licenses and approvals. - FY2020RestatedAnnual report
「The sale of active pharmaceutical ingredients and other products is subject to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other regulations. If the company violates these laws or regulations, or if qualified personnel leave and cannot be replaced, the relevant authorities may impose measures such as suspension of operations or revocation of licenses and approvals, which could materially affect the company's operating results.」
The company continues to disclose the risk of suspension of operations or revocation of licenses and approvals due to violations of pharmaceutical regulations or a shortage of qualified personnel. - FY2019RestatedAnnual report
「The sale of active pharmaceutical ingredients and other products is subject to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other regulations. If the company violates these laws or regulations, or if qualified personnel leave and cannot be replaced, the relevant authorities may impose measures such as suspension of operations or revocation of licenses and approvals, which could materially affect the company's operating results.」
The company continues to disclose the risk of suspension of operations or revocation of licenses and approvals due to violations of pharmaceutical regulations or a shortage of qualified personnel. - FY2019-Q1RestatedAnnual report
「During the cumulative first-quarter period, there were no new business or other risks and no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
The company has disclosed that there have been no material changes in the risk of business suspension due to violations of pharmaceutical regulations or revocation of licenses and approvals. - FY2018RestatedAnnual report
「The sale of active pharmaceutical ingredients and other products is subject to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other regulations. If the company violates these laws or regulations, or if qualified personnel leave and cannot be replaced, the relevant authorities may impose measures such as suspension of operations or revocation of licenses and approvals, which could materially affect the company's operating results.」
The company continues to disclose the risk of suspension of operations or revocation of licenses and approvals due to violations of pharmaceutical regulations or a shortage of qualified personnel. - FY2018-Q3RestatedAnnual report
「During the nine months ended September, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company has disclosed that there have been no material changes in the risk of business suspension due to violations of pharmaceutical regulations or revocation of licenses and approvals. - FY2018-Q2RestatedAnnual report
「During the six months ended June, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company has disclosed that there have been no material changes in the risk of business suspension due to violations of pharmaceutical regulations or revocation of licenses and approvals. - FY2017First statedAnnual report
「The sale of active pharmaceutical ingredients and other products is subject to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other regulations. If the company violates these laws or regulations, or if qualified personnel leave and cannot be replaced, the relevant authorities may impose measures such as suspension of operations or revocation of licenses and approvals, which could materially affect the company's operating results.」
Separate from approval acquisition risk, the company has for the first time identified the risk of suspension of operations or revocation of licenses and approvals due to violations of pharmaceutical regulations or a shortage of qualified personnel.