This Practice Note considers the Convention of 2 July 2019 on the Recognition and Enforcement of Foreign Judgments in Civil or Commercial Matters (the Hague Judgments Convention). The convention provides a framework for the enforcement of international civil or commercial judgments. This Practice Note sets out the background to the convention, its status and when it enters into force. It then explains the scope of the convention (Articles 1–3), as well as the mechanisms for recognition of judgments (Articles 4–7). It then considers interpretation and application, which includes procedure and costs (Articles 8–15) and finally the general clauses dealing with declarations, application of the convention where there are non-unified systems and the interaction of the convention with other international instruments. A definitions section is also included.
This Practice Note describes the difference between financial sanctions and export controls and sets out the need to and how to put in place policies and procedures to prevent breaching the sanctions regimes, including risk assessment, screening, staff awareness and training, licensing and disclosure and reporting requirements.
This Practice Note deals with pharmacovigilance. It sets out the EU and UK regulatory framework and discusses the role of the Pharmacovigilance Risk Assessment Committee (PRAC), EudraVigilance and the guidelines on good pharmacovigilance practices (GVPs). It then takes a more detailed look at the pharmacovigilance processes and requirements set out in the GVP modules, including: how to establish a pharmacovigilance system, the qualified person responsible for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF), pharmacovigilance inspections, pharmacovigilance audits, periodic safety update reports (PSURs), and post-authorisation safety studies (PASS). The Practice Note then considers non-compliance with pharmacovigilance requirements, data protection considerations, and outsourcing pharmacovigilance activities. Finally, it discusses pharmacovigilance in the UK and the role of the Medicines and Healthcare products Regulatory Agency (MHRA).
This Practice Note sets out what your business needs to know about the offences, penalties, investigations and enforcement actions associated with trade and financial sanctions.
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