Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 445

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 445
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 of medicine or pharmacy. Payments made to physicians in certain EU Member States must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities of the individual EU Member States. These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the EU Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment. Brexit and the Regulatory Framework in the United Kingdom Following the UK’s departure from the EU (commonly referred to as Brexit), the UK, EU pharmaceutical law no longer applies to the UK. The MHRA, the UK medicines and medical devices regulator, has published detailed guidance for industry and organizations to follow from January 1, 2021, which will be updated as the UK’s regulatory position on medicinal products evolves over time. European Data Collection The collection and use of personal health data in the European Economic Area, or the EEA, is governed by the GDPRwhich became effective May 25, 2018. The GDPR applies to any company established in the EEA and to companies established outside the EEA that processes personal data in connection with the offering of goods or services to data subjects in the EU or the monitoring of the behavior of data subjects in the European Union. The Company’s business may be affected by the requirements of, and potential penalties or liabilities imposed by the GDPR. Other Regulation For other countries outside of the European Union and the United States, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. Additionally, clinical trials must be conducted in accordance with GCP requirements and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. Additional Laws and Regulations Governing International Operations We are subject to numerous laws and regulations in each jurisdiction in which we plan to operate. The Foreign Corrupt Practices Act, or “ FCPA,” prohibits any United States individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of